Lanolin, hydrogenated

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

non-mutagenic

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The potential of the substance to cause gene mutations in bacteria was evaluated based on data on Similar Substance 02, due to the absence of data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

The test material was tested for its mutagenic potential in the Ames test, according to the OECD Guideline 471, EU Method B13/14, Japan Regulatory Authorities and USA, EPA OPPTS harmonised guidelines. A preliminary toxicity test (range was performed by using TA100 and WP2uvrA bacterial strains tested in 10 concentrations ranging from 0.15 to 5000 μg/plate. The test material was non-toxic to the strains of bacteria used. Subsequently, two individual experiments were performed by the use of direct plate incorporation and pre-incubation method. S.Triphimurium strains TA1535, TA1537,TA98, TA100 and E.coli WP2uvrA were treated with the test material using both Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10 % liver S9 in standard co-factors). The experiment was repeated on a separate day by using the pre-incubation method and by using fresh cultures of the bacterial strains and fresh test formulations. Negative (vehicle control-acetone) and positive controls run in parallel.

The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 mg/plate. A greasy, particulate precipitate was noted at and above 1500 and 5000 μg/plate in Experiments 1 and 2, respectively. This observation did not prevent the scoring of revertant colonies.

No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation or exposure method.

The test material is considered as non-mutagenic under tested conditions.

Justification for classification or non-classification

GERM CELL MUTAGENICITY

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.

Category 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:

- in vitro mammalian chromosome aberration test;

- in vitro mammalian cell gene mutation test;

- bacterial reverse mutation tests

The substance did not create gene mutations in the strains of Salmonella typhimurium and the one of E.coli in the in vitro gene mutation study in bacteria, therefore according to the 3.5. of the CLP Regulation (EC) No. 1272/2008, it is not classified as mutagenic for germ cells.