Registration Dossier

Administrative data

Description of key information

According to ECHA Guidance on the Application of the CLP Criteria (2017), Peru balsam oil can be classified as skin sensitizer based on its composition classified as skin sensitizer Cat1, above the generic concentration limit of 1%).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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
Parameter:
other: Classification
Remarks on result:
other: Skin sensitiser Category 1
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The substance is to be classified as Skin Sensitiser 1
Executive summary:

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. 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 in vitro or in vivo tests but some of its constituents are classified as skin sensitiser Cat.1B (beta-caryophyllene, alpha-pinene, beta-pinene, limonene, beta-myrcene, terpineol-4, alpha-terpinolene, delta-3 -carene, alpha-thujene, linalolp-metha-1,3 -dienene and fenchyl acetate) and each are present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. 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 in vitro or in vivo tests but some of its constituents are classified as skin sensitiser Cat.1B (beta-caryophyllene, alpha-pinene, beta-pinene, limonene, beta-myrcene, terpineol-4, alpha-terpinolene, delta-3 -carene, alpha-thujene, linalolp-metha-1,3 -dienene and fenchyl acetate) and each are present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, the registered substance is classified as skin sensitiser: Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation

(EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.