Registration Dossier

Administrative data

Description of key information

Oral route: Assessment of acute oral toxicity is not required because registered substance is used exclusively in production of cosmetic products falling within the scope of the Cosmetics Regulation, and the present tonnage band does not require quantitative assessment of risk to workers.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral route: The registered substance is used exclusively in production of cosmetic products falling within the scope of the Cosmetics Regulation, and the present tonnage band does not require quantitative assessment of risk to workers. Furthermore, stringent industrial hygiene practices routinely applied at production sites mean exposure of workers to the substance during formulation activities is expected to be minimal. The definition of workers assumed with respect to this substance is that given by ECHA Factsheet ECHA-14-FS-04-EN: Interface between REACH and Cosmetic regulations (October 2014) where it is stated that professional users and consumers shall not be considered as workers. Therefore, investigation of acute oral toxicity in vertebrate animals is scientifically unnecessary.

Inhalation route: Assessment of acute toxicity via the inhalation route is not required because registered substance is used exclusively in production of cosmetic products falling within the scope of the Cosmetics Regulation, and the present tonnage band does not require quantitative assessment of risk to workers. Furthermore,the substance has been shown to have a high onset boiling point (decomposition temperature > 200°C) and the vapour pressure has been determined to be5.7 x 10E-02Pa at 25 °C. It is therefore expected that inhalation exposure will be low during formulation of cosmetic products and experimental data from studies involving vertebrate animals would be unlikely to contribute significant information to the overall toxicological profile of the substance.

Dermal route: Assessment of acute toxicity via the dermal route is not required because registered substance is used exclusively in production of cosmetic products falling within the scope of the Cosmetics Regulation, and the present tonnage band does not require quantitative assessment of risk to workers. Furthermore, the test material has been shown to have a high onset boiling point (decomposition temperature > 200 °C) and the determined vapour pressure is low (5.7 x 10E-02Pa at 25 °C). These data indicate that the potential for dermal absorption after exposure to vapour is low. The substance is also a UVCB with a relatively high molecular weight, is poorly soluble (0.420 mg/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L.) and has a Log10 Pow value of 6.3 to 6.7. Consequently, and in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance (Version 3.0; June 2017), the substance is considered insufficiently soluble to partition from the stratum corneum into the epidermis and the majority of UVCB constituents are likely to be too large to favour dermal absorption (molecular weight > 100 g/moL and Log10 Pow > 4). Investigation of acute toxicity via the dermal route would therefore be unlikely to contribute significant information to the overall toxicological profile of the substance.

Justification for classification or non-classification

Investigation of acute oral toxicity and subsequent classification/non-classification is not required because the registered substance is used exclusively in production of cosmetic products falling within the scope of the Cosmetics Regulation and the present tonnage band does not require quantitative assessment of risk to workers. Assessment of risk to professional workers and consumers during use of formulated cosmetic products does not fall under the scope of REACH and is done in accordance with the Cosmetics Regulation (see ECHA Q&A ID: 0995; Version 1.1; Modified Date: 19/06/2017).