2,2-dimethylpropane-1,3-diol

Endpoint summary

Description of key information

In male and female rats combined the oral LD50 is 6920 mg/kg bw.
In an inhalation hazard test neither mortality nor clinical signs were found in male and female rats exposed to saturated vapour (140 mg/L) at 20°C for 8 h.
No mortality, no systemic toxicity but slight local effects were detected in guinea pigs after occlusive dermal exposure for 24 h to 4000 mg/kg bw; the LD50 is >4000 mg/kg bw.

Additional information

In a study comparable to OECD Guideline 401 (with acceptable restrictions; BASF 1966) groups of 5 male and 5 female rats were gavaged with 2, 16, or 30% aqueous solutions at dose levels of 200, 1600, 3200, 6400 mg/kg bw. The post exposure observation period was 7 days. Clinical signs occurred a few minutes after gavage: rats kept calm, showed slightly accelerated respiration, staggered gait, atony, apathy, and narkosis; no clinical signs were observed during the following 7 days. No mortality was detected at any dose level. The test substance is practically non-toxic. In conclusion, in male and female rats the oral LD50 is > 6400 mg/kg bw.

Very similar results were obtained in a further acute oral toxicity study (Eastman Kodak 1965; partly limited documentation). No mortality occurred at dose levels up to 6400 mg/kg bw and a post exposure observation period of 14 days.

In an earlier study (BASF 1958; study is comparable to OECD Guideline 401 with acceptable restrictions) groups of 5 male and 5 female rats were gavaged with an higher concentration (40% aqueous solutions, local effects on mucous membranes not excluded) at dose levels of 4.0, 6.3, 10, 12 g/kg bw in males and 4.0, 6.3, 8, 10, 12 g/kg bw in females. The post exposure observation period was presumably 7 days. Clinical signs occurred a few minutes after gavage: staggered gait, reduced muscle tonus, side position, no reflex, narkosis, death. The authors calculated a LD50 value of 6920 mg/kg bw for males and females combined. The test substance is practically non-toxic.

In the inhalation hazard test (BASF 1966; method described in the Annex of OECD Guideline 403; acceptable restrictions) 12 rats of both sexes (no further data) were exposed for 8 h to saturated vapour generated at a temperature of 20°C. The authors calculated a concentration of 140 mg/m³. No clinical signs were observed and no mortality occurred during the 7 days of post exposure observation period. No effects were detected at necropsy. In conclusion, neither mortality nor clinical signs were found in male and female rats exposed to saturated vapour at 20°C for 8 h.

Data on acute dermal toxicity are limited (data from secondary literature; Eastman Kodak 1983; no details available) but results correspond to data on other exposure routes. Guinea pigs were dermally exposed to 4000 mg/kg bw for 24 h. An occlusive coverage was used. No mortality was found; no systemic toxicity was detected. Only slightly to moderately irritating effects were reported. Conclusion: No mortality, no systemic toxicity but slight local effects were detected in guinea pigs after occlusive dermal exposure for 24 h to 4000 mg/kg bw; LD50 > 4000 mg/kg bw.

Justification for classification or non-classification

Classification is not warranted. The criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 are not met.