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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:

There is no data available on the skin sensitisation potential of Reaction products of oleoyl sarcosine with sodium hydroxide. In order to fulfil the standard information requirements set out in Annex VII, 8.3., in accordance with Annex XI, 1.5., of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5., of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substance listed below are selected as reference substances for hazard assessment.

Discussion

No studies are available investigating the skin sensitising properties of Reaction products of oleoyl sarcosine with sodium hydroxide. In order to fulfil the standard information requirements set out in Annex VII, 8.3. and in accordance with Annex XI, 1.5., of Regulation (EC) No 1907/2006, read-across from the structurally related category members Sodium N-lauroylsarcosinate (CAS 137-16-6) and (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) was conducted.

The skin sensitising properties of Sodium N-lauroylsarcosinate (CAS 137-16-6) were tested in a Guinea pig maximisation test according to EU method B.6 under GLP conditions (Cuthbert, 1987).

A preliminary range finding test was conducted to determine suitable concentrations for the main study for the intradermal injection and the patch testing. In the main study, female Dunkin-Hartley guinea pigs (20/group) were induced on Day 0 with 3 pairs of intradermal injections of FCA, 0.1 mL of the test substance alone and 0.05% test substance in FCA/water. Epicutaneous induction was done by application of the test substance at 5% in water on Day 8. The negative control group was treated with FCA, water or water/FCA alone. Six days after the injection phase the injection site of each of the test and control group animals was shaved again and then wetted with 10% aqueous SLS to provoke a mild inflammatory response to enhance the possibility of sensitisation. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions. Test substance was applied at a concentration of 5% on the right flank, and the vehicle was applied on the left flank, respectively. Evaluation of skin reactions was carried out 48 and 72 after challenge. No positive control substance was included in the study.

Moderate erythema was noted in test group animals, and slight erythema was noted in control group animals after induction. At challenge, all test and vehicle control animals showed no skin reactions after 48 and 72 h. No changes in body weight were observed in any animal during the study period. No further clinical signs were noted at any time point during the study.

Thus, the available data on skin sensitisation do not provide evidence for sensitising properties of Sodium N-lauroylsarcosinate (CAS 137-16-6).

The skin sensitising properties of (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) were tested in a guinea pig maximisation test similar to OECD Guideline 406 (Maurer, 1981).

In the study, Pirbright white guinea pigs (20/group) were induced with 3 pairs of intradermal injections of FCA, 5% test substance in 20% ethanol/80% saline and 5% test substance in FCA/saline-Mix using Freund’s Complete Adjuvant. Epicutaneous induction was done by application of the test substance at 30% in Vaseline PhH VI on the injection site on Day 8. A negative control group was included in the study but no information about treatment was given. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions. The test substance was applied on the flank at a concentration of 3%. Evaluation of skin reactions was carried out 48 h after challenge. No positive control substance was included in the study.

No skin reactions were observed in any animal in the negative control group. In the treatment group, three animals with very slight erythema and two animals with well-defined erythema were observed (corresponding to 25% positive results).

Thus, the available data on skin sensitisation do not provide evidence for sensitising properties of (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) under the conditions of the study.


Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising, based on read-across

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across based on a category approach and weight of evidence from these studies. The available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties among the category members and overall quality assessment (refer to the endpoint discussion for further details).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on the skin sensitisation of a substance structurally related to Reaction products of oleoyl sarcosine with sodium hydroxide do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

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