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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitising potential in Guinea pig maximisation test.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The substance was tested accordingo to OECD guideline 406 (Guinea pig maximisation test).

Test sample had 52.3 % purity and was identified as one of the main constituents of target substance. As no more analytical information on test sample was available, and considering that the other 2 constituents of target substance were very close to this one, i.e. obtained by hydrolysis of a sulphate group, experimental data was considered as reliable and representaive of target substance.

In the treatment group, 9/10 animals showed a positive skin response after challenge. As the percentage of animals with positive reaction is above the threshold of 60 % responding at 1 % intradermal induction, test substance is considered as potentially able to cause skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Following the definition set out in the CLP Regulation (EC 1272/2008), a skin sensitiser is a substance that will lead to an allergic response following skin contact. According to Table 3.4.3, the sub-category 1A for the maximisation test is assigned when the response is ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose.

The test was conducted with an intradermal injection and a dermal application of 1 % and 25 % of test material, respectively. The allergic response was seen in 90 % of treated animals. Thus, the substance was considered as capable to induce allergic response and was classified as Skin Sensitiser cat. 1A (H317: may cause an allergic skin reaction).