Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin sensitising potential of Camphor white oil.

Camphor white oil is not a skin sensitiser in the available study performed using a non-adjuvant method (Sharp, 1978). However relevant methodological deficiencies were noticed, questioning the reliability of the result. Indeed, some ingredients of Camphor white oil have been classified as skin sensitizers Cat.1B (cineole, pinene, limonene) and are all present above the generic concentration limit of 1%. Therefore Camphor white oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.

This conclusion is supported by a human case-report (Stevenson, 2003) in which positive reactions was observed following the cutaneous application of Camphor white oil at 10% in petrolatum.

Source: ECHA disseminated dossiers

-Pinene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html

- Cineole:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-dcd757ca-6791-7505-e044-00144f67d031/DISS-dcd757ca-6791-7505-e044-00144f67d031_DISS-dcd757ca-6791-7505-e044-00144f67d031.html


Migrated from Short description of key information:
Skin sensitiser, based on existing data and constituents concentration.

Justification for selection of skin sensitisation endpoint:
Available data indicates that the criteria are met for classification as skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
This information is not available

Justification for classification or non-classification

Harmonized classification:

Camphor white oil has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.

Self-classification:

Based on the typical composition provided by the Lead Registrant, Camphor white oil is classified as:

- May cause sensitisation by skin contact (Xi; R43) according to the criteria of the Annex VI of the Directive 67/548/EEC,

- Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.