Camphor tree, ext.

Endpoint summary

Description of key information

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 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 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 all present above the generic concentration limit of 1%.

Therefore Camphor white oil shall be classified as a Skin sensitizer Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1978

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Modified Draize procedure using 10 animals in test group instead of 20. Morevoer, some of the substances tested that were shown to be non-sensitizer under the study conditions are currently classified as skin sensitizer, so the test method is not considered to be reliable enough for the purpose of hazard assessment.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Modified Draize Procedure

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

other: modified draize procedure

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS (10 animals)
- Weight at study initiation: 350 g
- Housing: Animals were housed in pairs of same sex in wire mesh cages
- Diet: Pelleted guinea pig diet, cabbage and hay, ad libitum
- Water, ad libitum

Positive control results:

None

Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.

Executive summary:

In a modified draize procedure, ten guinea pigs were intradermally induced with 0.1 mL aliquots of Camphor white oil at 2.5 times the ICC at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Fourteen days later each animal was challenged intradermally in one flank and topically (uncovered) in the other flank with 0.1 mL aliquots of test substance at the respective ICC (0.15 %) and ACC (30 %). Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included. At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the ICC and ACC respectively. Preliminary study was conducted to determine the concentrations for main study.

Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.

 

Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.

Reference 2

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

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline required

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Key result

Parameter:

other: Classification

Remarks on result:

other: Skin sensitiser category 1

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.

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 (2017) 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 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 all present above the generic concentration limit of 1%.

Therefore Camphor white oil shall be classified as a Skin sensitizer Cat.1 without further testing according to the Regulation (EC) No 1272/2008, because sub-categories does not exist for the classification of the sensitisation hazard of mixtures.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Harmonized classification:

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

Self-classification:

Based on the typical composition provided by the Lead Registrant, Camphor white oil is classified as a Skin Sensitiser Cat. 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.