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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitization: sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
Classification based on calculation rules for mixtures of the CLP regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: accepted calculation method
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP regulation
Key result
Parameter:
other: Classification calculation
Remarks on result:
other: Skin sensitiser category 1

See attached document

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Based on the CLP classification rules, applicable for NCS, the Neroli oil (CAS 8016-38-4; List Nr 639-655-8) is classified for skin sensitization : Skin Sens.1 H317
Executive summary:

The NCS is composed of several identified constituents and according to CLP articles 10 and 11, it can be treated as a mixture for classification purpose. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the skin sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate and robust in vitro or in vivo tests, but one of its constituents is classified as Skin Sens.1 H317 (linalool) and is above the CLP generic concentration limit of 1% that triggers the classification of the mixture.

Therefore, the registered substance is classified for as a skin sensitiser category 1, according to the Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

One of the constituent of Neroli oil is classified as a skin sensitiser category 1, according to the Regulation (EC) No 1272/2008.

Although no sensitisation effects have been observed in the test performed with Neroli oil Tunisian, on human volunteers the uncertainties surrounding the quality of the test and the exact analytical profil of the substance tested, Neroli oil is classified a skin sensitiser category 1, according to the Regulation (EC) No 1272/2008.