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Survey and health assesment of chemicals substances in sex toys

5 Health risk screening and prioritization

• • 5.1.1 Elements
  • 5.1.2 Phthalate-based plasticizers
  • 5.1.3 Volatiles determined by headspace GC/MS
  • 5.1.4 Prioritization of light volatiles
  • 5.1.5 Screening of semi and heavy volatile substances from DCM extracts
  • 5.1.6 Prioritisation of semi and heavy volatile substances
• 5.2 Selection criteria for the migration analysis
  • 5.2.1 Products
  • 5.2.2 Hazardous substances

A health risk screening has been made of the substances identified at the screening analysis.  The screening is categorised according to the analytical method.

5.1.1 Elements

The results from the elements analyses are found in table 4.2 above, showing that sample 16 showed cadmium of 218 ppm with a relative uncertainty of 1.4 %. Tin of 250 and 310 ppm Tin was also detected in samples 1 and 2 with 260 ppm and 310 ppm respectively, and it is therefore important to know whether it is an organotin compound. According to the GC/MS screening it is the case for sample no. 2, as it contained trimethyltin chloride. By the GC/MS screening it is possible to detect other volatile organotin compounds, but only trimethyltin chloride and no other has been detected in sample 2.

5.1.2 Phthalate-based plasticizers

In the preliminary analytical screening phase the following phthalates identified and quantitatively determined: DEP, DEHP, DNOP and DINP.

The results are listed in Table 4.3 in chapter 4 and from this it appears that

10 of the 15 tested samples contain phthalates, even in rather large quantities, the samples being 2, 3, 4, 8, 9, 11, 12, 13, 14, and 15. The quantities varied from 0.12 g/kg to 702 g/kg, i.e. up to 70.2 %w/w.

It appears from the product labelling that samples nos. 1, 5, 6, 7 and 14 are latex-based products with no presence of phthalate plasticizers, except from nitrilbutadiene rubber (NBR). It is therefore assumed that sample 14 is manufactured from nitrile rubber. Migration of 3.3´-oxydipropionitrile (CAS no. 1656-48-0) from sample 14 the migration test mentioned in chapter 6 supports this assumption, as the substance is a difunctional nitrile.

Based on these results stated in Table 4 our further health risk assessment will be concentrated on:

• DEHP, Di-(2-ethylhexyl)-phthalate, CAS no.: 117-81-7
• DNOP, Di-n-octylphthalate, CAS no.: 117-84-0
• DINP, Di-iso-nonylphthalate, CAS no.: 28 553

5.1.3 Volatiles determined by headspace GC/MS

The results from the headspace-analyses at room temperature for 3 hours' exposure appear from table 4.4 and 4.5.

Based on the identified substances and their occurrences we have made a preliminary screening of the identified volatiles in order to make a selection of the most relevant substances. The screening comprised the classification and the determined limit values of the substances as workplace hygienic occupational value. The result is shown in Table 5.1.

Table 5.1 Volatiles in sex today, their classification etc. listed alphabetically

* : Classification from recommended list from EPA
H: Skin penetration, GV-list 2005 (C.0.1. 2005))
L: Limit value, GV-list 2005 (C.0.1. 2005))
K: Carcinogenic, GV-list 2005 (C.0.1. 2005))
Tentative: C.0.1. 2005)

5.1.4 Prioritization of light volatiles

Table 5.2 gives a prioritization of the substances according to their occurrences (quantity and no. of products) and their degree of health risk expressed through classification and data from the list of limit values.

Table 5.2 volatiles in sex toys prioritised for health assessment

In addition the following substances:

• Benzene, Carc1;R45  Mut2;R46 HK, 1 product (no.8)
• 1,2-Dichlorethane, Carc2;R45 1 product (no.12)
• Dichloromethane, Carc3;R40 HK, 2 products (nos.2 and 7)
• Diethylformamide, 1 product (no.1)

5.1.5 Screening of semi and heavy volatile substances from DCM extracts

The subject phthalate plasticizers has been dealt with in paragraph 5.1.2  A preliminary health risk screening of the other semi and heavy volatile substances from the extracts has been made in order to select the most relevant substances. The results are shown in Table 5.3. Some of the chemical substances have also been detected by a headspace analysis (Table 5.1).

Table 5.3 Semi to heavy volatile matters in sex toys and their classification

* Classification from the recommendation list

5.1.6 Prioritisation of semi and heavy volatile substances

Among the below chemical substances a few have been picked out according to their occurrences and assumed health risk.

Table 5.4 Selected chemical substances among the heavy volatile organic compounds for health assessment

Of the substances listed in Table 5.5, the following are prioritized for the following reasons:

• 2-Hexanone, as it may have long-term negative effects
• Trimethyltin chloride, as organotin compounds may be harmful

5.2 Selection criteria for the migration analysis

5.2.1 Products

Selection of products for migration tests has been effected on basis of  the results of the analytical screening of the purchased products and the above health risk screening of the detected chemical compounds. In order to make the project as many-sided as possible we have included different material types (vinyl, rubber, SEBS) and functions (dildo, artificial vagina, and gag). The country of origin has been a second parameter in the selection (China, Germany, Canada mm).

The most sold product group is vibrators functioning as dildos. In this group soft vinyl is the material group which contains most different critical health risk substances. The selection for migration studies has been based on information from interviews in the shops on product popularity among the users. Other considerations have been the content of different plasticizer types and differences of other hazardous substances with regard to both chemistry and concentrations.

Regarding products of rubber, neither the GC/MS on the DCM-extracts nor the headspace-analyses have detected such a large number of different hazardous substances as has been found in the vinyl-based products.

Based on the above selection criteria the following products have been selected for migration analysis.

No. 2 Vibrator in soft vinyl (dildo): The DINP-content is higher than 50 % w/w and the following substances are found in not inconsiderable amounts: toluene, guanidine, cyclohexanone, 2-butanone and trimethyltin chloride.

No. 8 Vibrator (dildo): DEHP 70.2 % w/w. Other substances: toluene, cyclohexanone, phenol, tetrahydrofuran.

No. 10 Artificial vagina and anus were selected for screening because it is made of a rather ”slimy” material which is gaining ground within manufacture of sex toys today. The screening analysis detected only a few substances (benzophenone and p-tert-butylbenzoic acid).

No. 11 Vibrator in soft vinyl (dildo): DNOP 23.9 % w/w. Other problematic substances: phenol, nonylphenol, tributylphosphate.

No. 14 Gag manufactured from rubber: DEHP 17.6 % w/w. Other problematic substances: phenol, toluene, naphtalene. The thin-layer chromatographic screening indicates that the accelerator may be of the "antabuse" type.

No. 15 Waterproof vibrator (dildo) in soft vinyl: DEHP 21 % w/w. Other problematic substances: toluene, o-xylene, cyclohexanone.

5.2.2 Hazardous substances

Based on the health screenings the below chemical substances have been estimated to be of interest for the actual health risk assessment.

Based on the health screenings and the selected products, the below chemical substances have been selected for health risk assessment:

Chemical substances indirectly determined by elements analysis

• Tin

Chemical substances identified in the headspace-analysis

• 2-Butanone
• Carbon disulfide
• Cyclohexanone
• Heptane
• 2-Hexanone
• Phenol
• Tetrahydrofuran
• Toluene

Chemical substances identified in dichloromethane extraction

• Bisphenol-A
• Trimethyltin chloride
• 2-Ethylhexanoic acid
• DEHP, Di-(2-ethylhexyl)-phthalate
• DINP, Di-iso-nonylphthalate
• DNOP, Di-n-octylphthalate

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Version 1.0 September 2006, © Danish Environmental Protection Agency