Camphor tree, ext.

Skin sensitisation

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

accepted calculation method

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only short abstract available

Type of sensitisation studied:

skin

Study type:

other: case report and patch testing

Principles of method if other than guideline:

A 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.

GLP compliance:

no

Type of population:

general

Controls:

None

Route of administration:

dermal

Results of examinations:

- One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum.
- A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions.

None

Conclusions:

Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization case in human.

Executive summary:

In a study, a 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.

 

One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum. A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions.

 

Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization in human.

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

Test material information

Constituent 1

Reference substance name:

Camphor tree, ext.

EC Number:

295-980-1

EC Name:

Camphor tree, ext.

Cas Number:

92201-50-8

IUPAC Name:

1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

Results and discussion

In vitro / in chemico

Results

Key result

Parameter:

other: Classification

Remarks on result:

other: Skin sensitiser category 1

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

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 been tested itself in an in vivo test but the study has been disregarded. Moreover, some of its constituents are classified as skin sensitisers Cat.1 and 1B (Dipentene, cineol 1,8, pinene alpha, pinene beta, 7-methyl-3-methyleneocta-1,6-diene, p-menth-1-en-4-ol, p-mentha-1,4(8)-diene and 5-isopropyl-2-methylbicyclo[3.1.0]hex-2-ene) and 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 because sub-categories does not exist for the classification of the sensibilisation hazard of mixtures.