Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Oral

A GLP-conform acute oral toxicity study with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters was investigated in male and female Wistar rats according to OECD guideline 401 (Biffi, 1992). The test substance in vehicle (sesame seed oil) was administered by gavage to groups of 5 animals per sex at a limit dose of 5000 mg/kg bw. No mortalities and no clinical signs were observed up to the end of the 14-day observation period. Body weights were not affected by treatment with the test substance. The necropsy and histopathological examination did not reveal substance-related findings. Based on the results, the oral LD50 value for male and female rats was greater than 5000 mg/kg bw.

Supporting information on acute oral toxicity is available for the target substances and expected hydrolysis products 2-Hydroxypropanoic acid (CAS 50-21-5, Lactic acid) and Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8). Alcohols, C12-13-branched and linear (CAS 75782-86-4) was investigated in an oral acute toxicity study in 3 male and 3 female Wistar rats according to OECD guideline 423 (Prinsen, 1998). Since no mortalities were noted during the 14-day observation period, the oral LD50 value for rats was considered to be greater than 2000 mg/kg bw. The study on the acute toxicity of the physiologically occurring metabolite 2-Hydroxypropanoic acid (L-Lactic acid) resulted in an oral LD50 value for rats of 3730 mg/kg bw (Andersen, 1998). No mortality occurred even after repeated oral administration of 5000 mg/kg bw/d in a subchronic oral toxicity study conducted with the read-across substance Tetradecyl 2-hydroxypropionate (CAS 1323-03-1). 10 Sprague Dawley rats per sex and group received undiluted test substance 5 days/week at dose levels of 500; 2500 and 5000 mg/kg/day for a period of 13 weeks (Faurot and Pennisi, 1985). An additional group of 10 animals per sex were sham-exposed and served as control group. All animals survived until study termination and their appearance and behaviour were not adversely affected by treatment. Thus the LD50 was considered to exceed 5000 mg/kg bw.

Inhalation

This information is not available.

Dermal

An acute dermal toxicity study was performed with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters similar to OECD guideline 402 (Biffi, 1993). Five male and five female rats were dermally exposed to the undiluted test substance at 2000 mg/kg bw for 24 h under occlusive conditions. Following exposure and up to the end of the 14-day observation period, no mortality occurred and no clinical signs or changes in body weight were observed. Therefore, the dermal LD50 in male and female rats was greater than 2000 mg/kg bw.

Supporting information on acute dermal toxicity is available for the target substance and expected hydrolysis product Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8). Alcohols, C12-13-branched and linear (CAS 75782-86-4) was investigated in an acute dermal toxicity study in 5 male and 5 female Wistar rats according to OECD guideline 402 (Prinsen, 1998). Since no mortalities were noted during the 14-day observation period, the dermal LD50 value for rats was considered to be greater than 2000 mg/kg bw.

Conclusions for acute toxicity

An acute oral toxicity study is available for the target substance Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters, in which no mortalities or adverse systemic effects in rats were observed. Based on these results, an oral LD50 value > 5000 mg/kg bw was derived. Likewise, the expected hydrolysis products Hydroxypropanoic acid (CAS 50-21-5, Lactic acid) and Alcohols, C12-13-branched and linear (CAS 75782-86-4) showed LD50 values exceeding the limit dose of 2000 mg/kg bw. In addition, no mortality occurred even after repeated oral administration of doses of 5000 mg/kg bw/d in a subchronic oral toxicity study, conducted with the read-across substance Tetradecyl 2-hydroxypropionate (CAS 1323-03-1).

Furthermore, no adverse effects were observed in two acute dermal toxicity studies with Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters, and with the read-across substance Alcohols, C12-13-branched and linear (CAS 75782-86-4, former CAS 67762-41-8), resulting in dermal LD50 values > 2000 mg/kg bw.

No information is available for acute inhalation toxicity of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters.

The available data indicate a very low level of acute toxicity for Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters and thus no hazard for acute oral and dermal toxicity was identified.

Justification for selection of acute toxicity – oral endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of acute toxicity – dermal endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on the acute oral and dermal toxicity of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

There are no data available on acute inhalation toxicity.