Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Data source

Reference
Reference Type:
other: Guidance
Title:
Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Author:
ECHA
Year:
2017
Bibliographic source:
ECHA-17-G-21-EN

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Constituent 1
Reference substance name:
Essential oil of Citrus sinensis (Rutaceae) peel, terpene-free
EC Number:
951-680-9
IUPAC Name:
Essential oil of Citrus sinensis (Rutaceae) peel, terpene-free
Test material form:
liquid
Details on test material:
Batch No. 0000448007
CAS No. not applicable
EC No. 951-680-9
Form: liquid
Colour: orange-yellow to green-yellow
Date received: 25 May 2020
Production date: 13 January 2020
Expiry date: 12 January 2021
Purity: 100% UVCB
Storage: fridge (6°C+/-3°C), darkness

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: classification
Remarks on result:
other: Skin sensitizer cat.1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.
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.


No skin sensitisation study was available on the registered substance. However, some of its constituents are classified as skin sensitisers Cat.1  (CAS 2244-16-8, 2244-16-8) or Cat. 1B (CAS 78-70-6, 141-27-5, 106-26-3, 112-54-9, 106-23-0, 87-44-5, 106-22-9)  and are present at concentrations 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 CLP and to the GHS. Sub-categorisation is not possible as data on individual constituants are not sufficient to differentiate sub-category 1A and 1B.