Lanolin, hydrogenated

Endpoint summary

Description of key information

LD50 (oral) > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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 study available

Additional information

The acute oral toxicity of the substance was evaluated considering data on the substance itself and on Similar Substance 02. Justification for Read Across is given in Section 13 of IUCLID.

The acute oral toxicity of the substance was assessed in a limit test according to according to the procedure suggested by Hagan, E.C. (1959). Five male and five female Wistar-derived albino rats were orally administered the substance, at 5000 mg/kg b.w. During the 14 -day observation period, mortality, body weight, signs of pharmacologic activity and drug toxicity were noted. All surviving animals were sacrificed and were subjected to complete gross necropsy. No substance-related findings, gross pathological changes or mortality was observed during the study. LD50 > 5000 mg/kg bw.

The acute oral toxicity of the similar substance was tested also in a limit test according to OECD Guideline 401 and EU Method B.1. Five male and five female Sprague-Dawley rats were orally administered the substance in sesame oil, at 2000 mg/kg b.w. During the 14 -day observation period, mortality, body weight, substance-related signs and changes (diarrhoea, lethargy, sleep, convulsions, somamotor activity, behaviour pattern, respiratory and circulatory system) were noted. All surviving animals were sacrificed and inspected macroscopically. No substance-related findings, gross pathological changes or mortality was observed during the study. The mean body weight for both males and females was increased after 7 and 14 days. LD50 >2000 mg/kg bw.

For the assessment of the acute oral toxicity of the substance, following a precautionary approach, the lower effect level is taken into account, i.e. LD50 > 2000 mg/kg, even if this effect level is obtained from the study on the similar substance and not the substance itself. In any case, no mortality was observed in either of the studies.

Justification for classification or non-classification

According to the CLP Regulation (EC) No. 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be above 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).

It is then concluded that the test substance is not classified for acute oral toxicity, according to the CLP Regulation (EC) No. 1272/2008.