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Appendices 1-18 to: Report on the Health Effects of Selected Pesticide Coformulants

74     Human toxicity

74.1     Single dose toxicity

Acute effects include primarily CNS depression and lactic acidosis form extremely high doses.

74.1.1     Inhalation

Ninety-three asthma-patients showed no adverse clinical effects from 15 minutes inhalation through a mask of an aerosol consisting of 0.005% isoproterenol-hydrochloride in a  40 % PG isotonic saline solution (Cohen & Crandall 1964).

74.1.2     Oral intake

A 15-month infant was given a vitamin C preparation containing 22.5 ml PG (equivalent to 23.8 g) as vehicle. The child experienced hypoglycaemia, irregular heart rate, sinus arythmia, tachypnea, tachycardia and perspiration. The effects disappeared upon cessation of treatment. (Martin & Finberg 1970 - quoted from LaKind et al. 1999).

No effects on the basal metabolic rate were demonstrated in a study of 3 human subjects administered 50 ml (51800 mg) PG (Hanzlik et al. 1939 - quoted from LaKind et al. 1999).

74.1.3     Dermal contact

An severely burnt 8-month infant (large surface of the skin with second and third-degree burns was treated topically over 70 hours with silver sulfadiazine containing 76.7 mg PG/g. The PG dose was calculated to 630 g/kg b.w. The treatment resulted in a peak serum PG level of 1059 mg/dl and caused acute metabolic acidosis and cardio-respiratory arrest, which may be due to the high serum PG levels. (Fligner et al. 1985 - quoted from LaKind et al. 1999).

74.1.4     Irritation and sensitisation

Cases of contact dermatitis have been reported from therapeutic and cosmetic products containing PG as a vehicle. Numerous patch test studies have been designed to determine the incidence and nature of PG skin reactions. Most of the positive reactions were found to be primary irritation, but several investigators were unable to conclude whether reactions to PG exposure were dermal irritation or true allergy. 

In a Draize test, 204 subjects were treated with 12 % and 89 subjects wit 60% PG in petrolatum over a 3-5 week period. No allergic response was seen at challenge with 72 hour contact to 12 % PG. (Marzulli & Maibach 1974 – quoted from Mortensen 1993).

In a modified Draize sensitisation study, 13 of 203 subjects showed a significant response to PG, by none of these subjects reacted to provocative use testing with 100 % PG. The authors concluded that PG was at lest a minimal irritant. (Trancik & Maibach 1982 - quoted from LaKind et al. 1999).

Frosch & Kligman (1977 - quoted from LaKind et al. 1999) classified 100% PG as a moderate skin irritant.

In another test, undiluted PG was applied to 1556 subjects for 20-24 hours. Skin reactions were seen in 12.5% of subjects, 70% of which were considered irritative and 30 % allergic, depending on onset time and area involved. Twelve out of 42 subjects with skin reaction also showed reaction were then tested with 10% PG in water. (Hannuksela et al. 1975 - quoted from Mortensen 1993).

Andersen (1980) pointed at the difficulty to evaluate a positive reaction and its clinical relevance, as false positive reactions occur commonly, and impurities may play a role. The incidence of PG allergy in the population was considered to be very low in relation to the extended use in consumer products.

74.2     Repeated dose toxicity

74.2.1     Inhalation

Exposure of children and adults to up to 94 mg PG/m³ (mean of 69 mg PG/m³) over weeks to months did not result in any adverse effects. (Harris & Stokes Jr, 1943 - quoted from A&H 1983).

No other data were found.

74.2.2     Oral intake

A child was given 2-4 ml of a vitamin D preparation containing 98% PG, twice a day for up to 13 months. The treatment corresponds to an exposure of 114-228 mg PG/kg b.w. day. After the 13 months, the child began to experience repeated seizures followed by a period of unconsciousness within 2 to 4 hours after the second daily dose. The symptoms disappeared when the treatment ceased. (Arulanantham & Genel 1978 - quoted from LaKind et al. 1999).

74.2.3     Dermal contact

No data were found.

74.3     Toxicity to reproduction

No data were found.

74.4     Mutagenic and genotoxic effects

No data were found.

74.5     Carcinogenic effects

No data were found.

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