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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation: causes serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, 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:
2 (reliable with restrictions)
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
Irritation / corrosion parameter:
other: Classification calculation
Remarks on result:
other: Skin Irrit.2 H315

See attached document

Interpretation of results:
Category 2 (irritant) 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 irritation : Skin Irrit. 2 H315
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 irritation/corrosion potential of the registered substance.

Twelve of its constituents are classified as Skin Irrit.2 H315((R)-p-mentha-1,8-diene, Linalool, Beta-Pinene, Linalyl acetate, Ocimene (trans beta), Terpineol (alpha), Myrcene, Geranyl acetate, Geraniol, Nerol, Farnesol (trans trans) and Alpha-pinene)) and the sum of their contents exceeds

the CLP generic concentration limit of 10% that triggers the classification of the mixture.

Therefore, the registered substance is classified for skin irritation Skin Irrit.2 H315 according to the Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, 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
Irritation parameter:
other: Classification calculation
Remarks on result:
other: Eye dam.1 H318

See attached document

Interpretation of results:
Category 1 (irreversible effects on the eye) 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 eye damage : Eye Dam.1 H318
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 eye irritation/corrosion potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests, but two of its constituents are classified as Eye Dam.1 H318 (geraniol and nerol) and the sum of their contents is potentially above the CLP generic concentration limit of 3% that triggers the classification of the mixture.

therefore, the registered substance is classified for serious eye damage Eye Dam.1 H318, according to the CLP Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritating potential of Neroli was tested on 25 humans subjects. After the application of the substance at 4% in petrolatum, for 48 -hr under occlusion, none of the subject had any irritation. The skin irritating potential of Neroli was also tested on intact or abraded rabbit skin. After the application of the substance under occlusion, no irritation was observed.

In a study of acute skin compatibility of a cosmetic product was carried out during 48 hours on 11 adults volunteers by single application of 0.02 mL of the pure subtance, with a semi-occlusive patch-test for, 48 hours. No irritation has been observed.

However, twelve of its constituents are classified as Skin Irrit.2 H315((R)-p-mentha-1,8-diene, Linalool, Beta-Pinene, Linalyl acetate, Ocimene (trans beta), Terpineol (alpha), Myrcene, Geranyl acetate, Geraniol, Nerol, Farnesol (trans trans) and Alpha-pinene)) and the sum of their contents exceeds the CLP generic concentration limit of 10% that triggers the classification of the mixture.

Justification for classification or non-classification

Skin irritation

Twelve of the constituents of Neroli oil are classified as Skin Irrit.2 H315((R)-p-mentha-1,8-diene, Linalool, Beta-Pinene, Linalyl acetate, Ocimene (trans beta), Terpineol (alpha), Myrcene, Geranyl acetate, Geraniol, Nerol, Farnesol (trans trans) and Alpha-pinene)) and the sum of their contents exceeds the CLP generic concentration limit of 10% that triggers the classification of the mixture.

Although no irritation effect has been observed in the tests with the substance on human and rabbit skin, the uncertainties surrounding the quality of the test and the exact analytical profil of the Neroli tested, Neroli oil is classified as skin irritant cat. 2, according to the CLP regulation.

Eye irritation

Neroli oil has not been tested itself in appropriate in vitro or in vivo tests, but two of its constituents are classified as Eye Dam.1 H318 (geraniol and nerol) and the sum of their contents is potentially above the CLP generic concentration limit of 3% that triggers the classification of the mixture.

therefore, Neroli oil is classified for serious eye damage Eye Dam.1 H318, according to the CLP Regulation.