Glycerides, castor-oil mono-, di- and tri-

Endpoint summary

Description of key information

Acute oral toxicity: A study, similar to OECD401 was performed with the read-across substance CAS 91744-44-4: LD50> 5000 mg/kg bw

Acute dermal toxicity: OECD402: LD50> 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

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

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity (CAS 91744-44-4)

In a study similar to OECD 401, the acute oral toxicity of the test item was assessed in TNO Wistar rats. Using propylene glycol as vehicle, the test item was administrated orally at a single dose of 5000 mg/kg on an empty stomach. 10 rats (5 female and 5 male) were used for the study. After administration of the test item, the animals were observed for 14 days. Deaths and clinical symptoms were recorded and necropsy was performed. The first five hours of application the animals had an ruffle fur, no other clinical signs were recorded and no deaths occurred during the 14 day observation period. The only observation at necropsy was hydrometra in one animal. Based on these data, the LD50 was above 5000 mg/ kg bw/day. Therefore, the substance is not considered to be acutely harmful (BASF, 1984).

Acute dermal toxicity (CAS 91744 -27-3)

In a study performed according to OECD 402 and GLP, the acute dermal toxicity of the test item was assessed in Wistar Crl:WI (Han) SPF rats. A dose of 2000 mg/kg bw undiluted substance was applied to about 40 cm² clipped dorsal and dorsolateral parts of the trunk of 5 males and 5 female animals for 24 hours under semi-occlusive conditions. The test substance was removed with warm water and the animals were observed for 14 days. Mortality, clinical symptoms and bodyweight were recorded and necropsy with gross-pathology examination was performed. In addition, skin findings were scored. No mortality occurred and no systemic clinical signs were observed during clinical examination of both sexes. The body weights of the male and animals increased within the normal range throughout the study period, with the exception of two females in the first week after exposure. However, these observations were considered unspecific. Very slight erythema (grade 1) was observed in three male and four female animals from study day 1 until study day 2 or 3. Based on these data, the LD50 was above 2000 mg/ kg bw/day. Therefore, the substance is not considered to be acutely harmful (Bioassay, 2017).

Justification for classification or non-classification

Based on the available data no classification and labelling is warranted for acute oral and dermal toxicity in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008