Reaction mass of (9-acetoxy-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-azaspiro[5.5]undec-3-yl)methyl palmitate and (9-acetoxy-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-azaspiro[5.5]undec-3-yl)methyl stearate

Endpoint summary

Description of key information

LLNA (OECD 429; RCC 848427,2003) = sensitizing

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

According to regulation (EC) No 1907/2006, Annex XI, paragraph 1.5., substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).

The source (CAS 376588-17-9) and target (EC 936-831-9) substance share identical structural elements, the only difference being the length of the carbon chain at the ester function. The source chemical is esterified with stearic acid (C18), whereas the target compound is a mixture of stearate (C18) and palmitate (C16), with the stearate version accounting for about 60% of the chemicals present in the target compound. Therefore, 60% of the target compound are identical with the source chemical and the remaining molecules of the target compound are nearly identical with the only difference being the chain length at the ester group. It is expected that the structural difference between the octadecanoate and the hexadecanoate does not affect the physico-chemical properties, the toxicological and ecotoxicologocal profile as well as the environmental fate. Both substances are characterized by similar values for water solubility, vapor pressure and log POW. Furthermore, it can be assumed that the degradation products of CAS 376588-17-9 are very similar to the degradation products of the mixture containing the octadecanoate and the hexadecanoate. In addition, both substances triggered comparable (eco)toxicological effects.  Therefore read-across to CAS 376588-17-9 is scientifically justified for physico-chemical properties, the toxicological and ecotoxicologocal profile as well as environmental fate. For more information on the read-across approach, please refer to the Chapter 13 (attached read-across justification).

The sensitization potential was evaluated in a GLP compliant guideline study according to OECD 429 (RCC, 848427, 2003) with the source substance. The substance was found to be a skin sensitizer.

Key information:

According to the analogues approach, no additional information is needed to conclude on the senitizing potential of the registered substance. The registered substance according to the CLP Regulation (EC) No. 1272/2008 as skin sensitizer in Cat 1B / H317.

According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. As the test substance is contained in finished articles below the limits identified in Article 14(2) of REACH, in fact it is lower than 1% (ECHA GD chapter R7c, March 2020) no risk assessment has to be performed. This is supported by additional product tests, which showed that the test substance was not sensitizing when tested up tp 10% in PP.

 

Additional information: product testing with the source chemical

Several product tests were performed. The test substance (CAS 376588-17-9) was found to be not sensitizing in the following LLNA (OECD 429) tests:

- RCC 850009. 5% test substance in PP/190°C. (Concentrations:2.5, 5, 10% in Acetone:olive oil (4:1))

- RCC 850010. 5% test substance in PP/175°C. (Concentrations:2.5, 5, 10% in Acetone:olive oil (4:1))

- RCC 850012. 10% test substance in PP/175°C. (Concentrations:1, 2.5, 5% in Acetone:olive oil (4:1))

According to the analogues approach, it is assumed that the target chemical is also not sensitizing when tested in 5% and 10% in PP.

 

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as sensitizing to skin under Regulation (EC) No. 1272/2008.