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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

non skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The skin sensitisation potential of the substance was evaluated in a weight-of-evidence approach based on data from an in-vivo animal study on Similar Substance 01 and on skin sensitisation data on humans on the substance itself as well on Similar Substance 01 and 02. Justification for Read Across is given in Section 13 of IUCLID.

In the guinea pig maximisation test 25 guinea pigs were intradermally injected with two pairs of three injections (1) 0.1 ml of the adjuvant without the test material, (2) 0.1 ml of test agent without adjuvant and (3) 0.1 ml of the test substance emulsified in complete adjuvant. This responds at 5 % of intradermal induction dose. A week after, the substance was topically applied at 25 % w/w to the same area as the intradermal induction exposure site. After two weeks the animals were challenged by topical application at 15 % and the challenge sites were evaluated 24 hrs after removal of the patch and reexamined in an additional 24 hours for signs of allergic reactions. None of the animals tested presented any allergic reactions throughout the study period. Similar substance 01 is not a skin sensitiser.

Further data were retrieved from skin sensitisation studies on humans and from the analysis of the data obtained in different patch tests. The substance and similar substances seem to cause a skin sensitisation on human skin after patch testing, however, in a very low percentage (i.e. 1 -4.4 %). In one of the patch test with hydrogenated lanolin and anhydrous lanolin, hydrogenated lanolin had a greater skin sensitisation potential than the anhydrous one. It was suggested that this was observed possibly due to the presence of nickel and chromium present as impurities in hydrogenated form. Furthermore, it is suggested that the main components responsible for the allergenic properties of lanolin seem to be the aliphatic fatty alcohols, especially myristic and cetyl alcohol. Hydrogenated lanolin and other lanolin derivatives are complex substances with a varied composition. For the evaluation of the skin sensitisation profile of the substance, it was considered as more appropriate to use more than one studies with different test materials in order to assess this variation of composition.

The substance was also evaluated for its dermal tolerability on human volunteers. For this reason, 14 subjects age 24 -44 years were subjected to a dermal application of the test substance on the palm. The tested site was controlled after 24 and 48 hours by the same doctor and possible skin reactions such as erythema were noted (as present or absent). No evidence of dermal intolerance of the substance was noted. None of the subjects complained for itching or any other indications of intolerance. The test material was found to be tolerable by the human volunteers.

Justification for classification or non-classification

According to the CLP Regulation (EC) No.1272/2008 Annex I: 3.4.2.2.1.4, Table 3.4.2:

Substances shall be classified as skin sensitisers (Category 1) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (see specific criteria in paragraph 3.4.2.2.4.1).

Sub-category 1A: Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Evidence of skin sensitisation in humans normally is assessed by a diagnostic patch test. When considering human evidence, it is necessary to take into account the size of the population exposed and the extent of exposure and frequency, and thus the consideration is on a case by case basis. Patch test concentrations and substances must be suitable for the purpose, not causing false negatives, false positives, irritant reactions or inducing contact allergy (skin sensitisation). The patch tests evaluated had a varying testing population ranging from 14 -24449, negative and positive controls run in parallel in most of the studies and the subjects age, sex and health history was also considered.

Skin sensitisation occurred during the patch test on the substance, however, not in a substantial number of persons. Furthermore, in the guinea pig maximisation test no skin sensitisation was noted. Taking into account the aforementioned, the substance is not classified for skin sensitisation according to the CLP Regulation (EC) No.1272/2008.