Survey of Chemical Substances in Consumer Products, 57 – Screening for health effects from chemical substances in textile colorants

Screening for health effects from chemical substances in textile colorants

4 Conclusion

From the substances that were identified in the survey report (Miljøstyrelsen 2004) a number was selected for further evaluation of a potential health risk to the consumers based on classification and frequency. The consumers are in this context defined as children at the age around 7-8 years with a body weight of 20 kg.

The table below summarises the results of the assessment of the individual substances and the determined concentrations.

Table 32. Summary of conclusions

Chemical substance	Measured concentrations in products	Total uptake (inh+derm+oral) μg/kg bw/day	Reference value mg/kg bw/day	MOS	Conclusion
1-Butanol	Detected in 6 samples. The concentrations were between 77 and 690 mg/kg	2.2 - 19.9	NOAEL: 125 RfD: 0.5	>6280	No health risk from any of the samples.
Caprolactam	Detected in 1 sample. The concentration was 1100 mg/kg	30.3	NOAEL: 50	1650	No health risk from the sample.
1,4-Dichlorobenzene	Detected in 1 sample. The concentration was 9.9 mg/kg	0.28	NOAEL: 10 ADI: 0.107	35710	No health risk from the sample. (NB carcinogenic)
Diethylene glycol	Detected in 2 samples. The concentrations were 6200 and 53000 mg/kg	170 and 1457	NOAEL: 64	>43	No health risk from any of the samples.
Diisopropylene glycol	Detected in 6 samples. The concentrations were between 390 and 5100 mg/kg	11 – 140	NOAEL: - (used analogous NOAEL: 64)	>456	No health risk from any of the samples.
1,4-Dioxane	Detected in 2 samples. The concentrations were 4.7 and 11 mg/kg	0.13 and 0.30	NOAEL: 10	>33000	No health risk from any of the samples. (NB carcinogenic)
Glycerine	Detected in 2 samples. The concentrations were 11000 and 27000 mg/kg	303 and 743	NOAEL: 5000	>6730	No health risk from any of the samples.
Hexamethyl- entetramine (=methenamine)	Detected in 6 samples. The concentrations were between 11 and 860 mg/kg	0.3 – 24	NOAEL: 27	>1125	No health risk from any of the samples.
Isobutane	Detected in 2 samples. The concentrations were 2000 and 3500 mg/kg	871 and 1525	NOAEL: - est. NOAEL: 7.3	- 4.8	No health risks from any of the samples if short term exposure and ventilation is presumed.
3-Isocyanatomethyl-3,5,5-trimethyl-cyclohexyl isocyanate (IPDI)	Detected in 1 saple. The concentration was 270 mg/kg	7.4	est. NOAEL 0.021	2.8	No health risks if short term exposure and ventilation is presumed. (NB allergenic)
N-Methyl-2- pyrrolidone	Detected in 1 sample. The concentration was 740 mg/kg	20.4	NOAEL: 169 TDI: 0.6	8250	No health risk from the sample.
2-Phenoxyethanol	Detected in 2 samples. The concentrations were 460 and 4900 mg/kg	12.7 and 135	NOAEL: 200	>1480	No health risk from any of the samples.
Propylene glycol	Detected in 5 samples. The concentrations were between 36 and 7100 mg/kg	1.0 – 195	NOAEL: 1300 ADI: 25	>6650	No health risk from any of the samples.
Antimony	Detected in 3 samples. The concentrations were between 64 and 84 mg/kg	0.18 – 0.23	LOAEL: 0.43 NOAEL: 6	>1860 >26000	No health risk from any of the samples. (NB antimony trioxide carcinogenic)
Copper	Detected in 4 samples. The concentrations were between 38 and 2400 mg/kg	0.5 – 30.6	NOAEL: 17 TDI: 0.43	>556	No health risk from any of the samples.

In spite of none of the identified substances could be assessed to pose an immediate health risk to the consumer it should be pointed out that the classification of some of the identified substances was of a serious character.

In the screening of the classification was found that out of the 63 identified chemical substances 28 substances were classified in the List of dangerous substances and 5 could be classified according to the Danish Environmental Protection Agency's Advisory list for self-classification. One substance was classified Carc.cat.1 (May cause cancer), 5 substances were classified Carc.cat.3;R40 (Limited evidence of carcinogenic effects ), and 1 substance was classified mutagenic Mut.cat.2;R46 (May cause heritable genetic damage). Three substances were classified R42 and/or R43 (May cause sensitization by inhalation and/or by skin contact), and further 2 substances were in the same category according to the Danish EPA's Advisory list for self-classification. In total 13 organic substances were selected for a further health assessment.

Selected products were further analysed for 3 metals of which 2 were found at concentrations above the detection limit. The two substances (antimony and copper) were selected for further evaluation.

The health assessment is performed based on realistic "worst case" scenarios according to the methods developed by EU for risk assessment of chemical substances. This means that relevant levels were identified at which no adverse health effects are expected (NOAEL: no observed adverse effect level) or an established threshold limit value for uptake. This value was then compared with the estimated concentrations or uptakes in the selected scenarios.

In the scenarios, an assessment was performed based on exposure via inhalation of volatile substances during the use of textile colorants, by dermal contact if the consumer gets his hands contaminated or is exposed by an equal amount from the dyed textile. Further, a scenario is included for oral exposure based on mouthing of fingers, product or dyed textiles. The latter may hardly be avoided if the family includes toddlers.

Two of the evaluated substances (1,4-dichlorobenzene and 1,4-dioxane) are classified carcinogenic category 3 (R40 Limited evidence of carcinogenic effect). Both substances have been assessed in the EU risk assessment programme. The reports indicate a threshold to carcinogenic effects. Thus at the determined levels the substance may not be of significance but the manufacturer and the consumer perhaps should consider alternatives.

Antimony trioxide has the same classification. The EU risk assessment is not finalised and whether it actually is antimony trioxide or another antimony compound that is contained in the products is unknown.

The product containing 3-isocyanatomethyl-3,5,5-trimethyl-cyclohexyl isocyanate is assessed not to pose an immediate health risk to the consumer of the studied textile colorant. However, the MOS is low indicating a potential health concern and prolonged exposure should be avoided with products containing this substance. It should be noted also that the substance may be allergenic (may cause sensitisation by skin contact and by inhalation). Heating of the colorants should be performed under forced ventilation.

Products containing isobutane also had a very low margin of safety (MOS) indicating a potential health concern. Prolonged exposure should be avoided with products containing this substance. Use of products containing the substance should be performed under aeration or ventilation.

Substances classified as irritants were detected at concentrations below the reported irritating concentrations.

The conclusion of the project is that none of the evaluated chemical substances would cause any immediate adverse health effects to the consumer at the estimated exposure levels by inhalation, dermal or oral contact.

The assessments are in most cases performed by comparing data from long-term studies or even chronic data. As the exposure to textile colorants must be assumed to be actually within shorter periods the conclusions should be acceptable.

However, it should be noted that the consumer is exposed to more than one of the substances simultaneously. Because the effect levels used in the evaluation are based on varying effects they can not be added. Further the consumer may be exposed to the same substances form other sources, e.g. other products, environment or food, which could result in a total exposure above the no-effect levels or tolerable daily intake values. Especially exposure to substances with low margins of safety (low MOS values e.g. isobutane and 3-isocyanatomethyl-3,5,5-trimethyl-cyclohexyl isocyanate) may be critical.