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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two studies have been conducted on Guinea Pig. The Key study (RCC, Research & Consulting Company AG. 1991) has been performed in GLP and the purity of the substance is known. For the supporting study the purity is unknown, but the two of them are confirming that the substance is not a skin sensitizer.

Furthermore a third study was performed on guinea pigs; unfortunately the original study reports is not more available, but there is only a summary reporting some toxicological test results on CAS 16090-02-1. The available information included in the toxicological test results summary indicate that the substance did not induced skin sensitization (Archroma GmbH, 1969).

REFERENCE

Archroma (1969). Toxikologische Untersuchung von Leukophor 6807. Unpublished data. Testing laboratory: Pharma-agroforschung. Owner company: Archroma GmbH. Report N. 22/69. Report date: 1969 -07 -02.


Migrated from Short description of key information:
Not skin sensitising (OECD 406) No effects in any animal

Justification for selection of skin sensitisation endpoint:
Study conducted according to internationally accepted testing guidelines and performed according to GLP. The sample tested is representative for the market batches.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Two studies were conducted on Guinea Pig. The Key study (Research & Consulting Company AG. 1991) was performed in GLP and the purity of the substance is known. No positive reactions were evident after the first challenge application, neither when treated with vaselinum album only nor when treated with a 25 % test article dilution.

In the supporting study (Ciba Geigy Ltd., 1975) the composition of the lot tested is unknown. Nevertheless, no difference between the test and the control group was found after epidermal challenge and thus it was concluded that the substance is not sensitizing to skin.


Migrated from Short description of key information:
Not skin sensitising.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact. The criteria to classify a substance as skin sensitizer, on the basis of results from test animals, are reported into the second adaptation to technical progress*: a substance in considered a skin sensitizer when:

- an adjuvant type test method for skin sensitisation is used and a response of at least 30 % of the animals is considered as positive;

- for a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive;

- a stimulation index of three or more is considered a positive response in the local lymph node assay.

No positive reactions were evident after the first challenge application, neither when treated with vaselinum album only nor when treated with a 25 % test article dilution in both reported studies.

In conclusion, the available experimental data are adequate for classification and labelling and according to the CLP Regulation (EC 1272/2008), the test substance is not classified as skin sensitizing.

*Commission Regulation (EU) No 286/2011 of 10 March 2011, amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.