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Description of key information

All available acute toxicity studies within this category showed that LCAEs are non-toxic via the oral and dermal route.
Studies on acute oral toxicity were available for the following members of this category (CAS No.): 3687-46-5 and 95912-87-1.
Studies on acute oral toxicity were available for (CAS No.): 3687-46-5:
Key, Dufour, 1994, Stearinerie, AOT mouse, RL2 – LD50 oral > 2000 mg/kg bw.
Gloxhuber, 1967, Cognis, AOT rat, RL2 –LD50 oral >17000 mg/kg bw.
Potokar, 1970, Cognis, AOT, rat, RL2 –LD 50 oral > 8660 mg/kg bw.

RA-C, CAS 95912-87-1, Kaestner, 1977, Cognis, AOT rat, RL2-LD50 oral > 5000 mg/ kg bw.
RA-C, CAS 3687-46-5, key, Dufour, 1994, Stearinerie, AOT mouse, RL2- LD50 oral > 2000 mg/kg bw.
Study on acute dermal toxicity was available for (CAS No.).3687-46-5.
Key, Beerens-Heijnen, 2010, Cognis, rat, RL1 –LD50 dermal >2000 mg/ kg bw.
There were no acute inhalation toxicity studies available.

Key value for chemical safety assessment

Additional information

All available experimental data on acute oral and dermal indicate that the members of this category are practically non-toxic:

Acute oral toxicity:

A reliable acute oral toxicity study (limit test) was performed with Decyl oleate (CAS No.3687-46-5) similar to OECD Guideline 401 (Dufour, 1994). 5 Female NMRI EOPS mice received single oral dose of 2000 mg kg bw. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 in mice was found to be greater than 2000 mg/kg bw.

An acute oral toxicity study (limit test) was performed with Fatty acids, C16-18, C12-18-alkyl esters (CAS No.95912-87-1) similar to OECD Guideline 401 (Kaestner, 1977).10 male Wistar rats received single oral (gavage) dose of 5000 mg/kg bw. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 in rat was found to be greater than 5000 mg/kg bw.

An acute oral toxicity study (limit test) was performed with Decyl oleate (CAS No.3687-46-5) similar to OECD Guideline 401 (Gloxhuber, 1967). 10 rats received by oral gavage a dose of 17000 mg/ kg bw. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 in rat was found to be greater than 17000 mg/kg bw.

An acute oral toxicity study (limit test) was performed with Decyl oleate (CAS No.3687-46-5) similar to OECD Guideline 401 (Potokar, 1970). 10 Wistar rats received by oral gavage a dose of 8.66 g/ kg bw. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 in rat was found to be greater than 8.66 g/kg bw.

 Acute dermal toxicity:

An acute dermal toxicity study (limit test) was performed with Decyl oleate (CAS No.3687-46-5) similar to OECD Guideline 402 (Beerens-Heijnen, 2010). Five Wistar rats of each sex received a single dermal application of 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Piloerection and/ or chromodacryorrhoea were noted in all males on Day 1 and/ or 2. No clinical signs of systemic toxicity were noted in females. Scales, scabs, focal erythema were seen in the treated skin area of all females and three males during the observation. The changes noted in bodyweight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value in Wistar rats was established to exceed 2000 mg/ kg bodyweight for the substance.

Justification for classification or non-classification

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute toxicity, no classification is required

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