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Description of key information

Skin sensitisation: skin sensitiser, based on classified constituents.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1985
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non adjuvant method, relevant deficiencies. Uncovered test site. Application site changed if very strong reactions provoked. No detail on test results / dose tested and selection.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
Open epicutaneous test
GLP compliance:
not specified
Type of study:
open epicutaneous test
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 300-450 g
Route:
epicutaneous, open
Vehicle:
other: unchanged or concurrent vehicle
Concentration / amount:
Range finding tests: 100, 30, 10, 3 and 1 %
Main test:
- Induction phase: 100, 30, 10, 3, 1 and 0.3 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations
Route:
epicutaneous, open
Vehicle:
other: unchanged or concurrent vehicle
Concentration / amount:
Range finding tests: 100, 30, 10, 3 and 1 %
Main test:
- Induction phase: 100, 30, 10, 3, 1 and 0.3 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations
No. of animals per dose:
At least 6 animals in each treatment group (maximum: 20) and 10 animals in control group
Details on study design:
RANGE FINDING TESTS: On a day before starting the exposure (Day -1), a single application of 0.025 mL of each test concentration (100, 30, 10, 3 and 1 %) was simultaneously performed on clipped flank skin (2 cm2) of 6-8 animals and the reactions were recorded after 24 h. The minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Test groups: Open epicutaneous application of 0.1 mL of each test concentration (100, 30, 10, 3, 1 and 0.3 %)
- Control group: No treatment or topical (uncovered) application of 0.1 mL of vehicle
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. When very strong skin reactions were provoked, the application sites were changed.
- Duration: Days 0-20
- Evaluation: Dermal reactions were recorded at 24 h after each application or at the end of each week and the minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 21 and 35
- Test and control groups: Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material
- Site: Contralateral flank (2 cm2)
- Evaluation (h after challenge): 24, 48 and/or 72 h
Challenge controls:
Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on control animals during challenge phase.
Positive control substance(s):
not specified
Positive control results:
Not applicable

No positive reaction was observed after challenge exposure.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the test conditions, Eucalyptus oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
Executive summary:

In an open epicutaneous test (OET), groups of guinea pigs were topically (uncovered) induced with 0.1 mL of Eucalyptus oil at doses of 100, 30, 10, 3, 1 and 0.3 % on clipped flank skin (8 cm2), daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. The application sites were changed if very strong skin reactions were provoked. At least 6 animals were used in each treatment group and 10 animals in control group. On Days 21 and 35, an open epicutaneous challenge application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on the contralateral flank (2 cm2) of the animals and the dermal reactions were recorded after 24, 48 and/or 72 h.

Under the test conditions, Eucalyptus oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).

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
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 1B
Interpretation of results:
Category 1B (indication of skin sensitising potential) 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 (2015) 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 sensitisers Cat.1B (cineol 1,8; dipentene, alpha pinene...) and are all potentially 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. 1B without further testing according to the Regulation (EC) No 1272/2008.

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

Eucalyptus globulus oil is not a skin sensitiser in the available study performed using a non-adjuvant method (Klecak, 1985). However relevant methodological deficiencies were noticed, questioning the reliability of the result.

Indeed 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 (2015) 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 sensitisers Cat.1B (cineol 1,8; alpha pinene, dipentene ...) and are all potentially 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. 1B without further testing according to the Regulation (EC) No 1272/2008.


Migrated from Short description of key information:
Skin sensitiser, based on 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:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.

Self-classification:

Based on the available information the substance 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.