Registration Dossier
Registration Dossier
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EC number: 290-163-6 | CAS number: 90082-72-7
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: skin sensitizer,
based on available human and animal data and the presence of classified
ingredients (WoE).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21 September 1976 - 04 February 1977
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet criteria of today's standard method, however the result is in accordance with the classification obtained using additivity approach per constituent
- 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:
- The method is modified from Draize. In the Draize test sensitization is induced by 10 intradermal injections of test substance at the ICC (injection challenge concentration) given over a 3 week period, whereas in this method the equivalent total dose is administered at one time by 4 intradermal injections each 2.5 times the ICC. 14 days later each animal is challenged intradermally in one flank and topically in the other with 0.1 mL aliquots of test substance at the respective ICC and ACC (application challenge concentration) and 24 h later reactions are scored.
Guinea pigs were treated to induce sensitization by intradermal injection and were challenged 2 weeks later by both intradermal injection and topical application. A second challenge with controls was made a further week later to clarify possible sensitisation seen at first challenge followed by a further cross-challenge. The induction procedure was then repeated and the animals challenged after two weeks. A final confirmatory challenge with controls was made. - GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: intradermal injection - 0.01 % Dobs/saline; topical application - alcohol
- Concentration / amount:
- Induction phase (intradermal injection): 0.25 %
Challenge phase:
- Intradermal injection: 0.1 %
- Topical application: 25 % - Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal injection - 0.01 % Dobs/saline; topical application - alcohol
- Concentration / amount:
- Induction phase (intradermal injection): 0.25 %
Challenge phase:
- Intradermal injection: 0.1 %
- Topical application: 25 % - No. of animals per dose:
- Preliminary irritation test: 4 males
Main test: 4 males for control and 10 animals (4 males and 6 females) for test item - Details on study design:
- PRELIMINARY IRRITATION STUDY:
- Intradermal injection: Four males were injected intradermally on the shaved flanks with 0.1 mL aliquots of a range of concentrations of test substance (0.05 to 1 %). 24 h later the reactions were examined for size (two largest diameters), erythema and oedema and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
- Topical application: Four males were topically applied with 0.1 mL aliquots of a range of concentrations of test substance in small circular areas to the shaved flanks. 24 h later the reactions were examined for erythema and the highest concentration, which causes no irritation was selected as the application challenge concentration (ACC).
MAIN STUDY
Induction Exposure: For each animal 0.1 mL aliquots of test substance (0.25 %) were injected intradermally at 4 sites which overlie the 2 axillary and 2 inguinal lymph nodes.
Challenge Exposure: 14 days later each animal was challenged intradermally in one flank and topically in the other with 0.1 mL aliquots of test substance at 0.1 and 25 %, respectively. 24 h later skin reactions were scored.
- As there was no sensitization after one induction treatment, the induction procedure was repeated and the animals were challenged 2 weeks later. A confirmatory challenge with control was performed further 7 days later.
Scoring
- Reactions were examined under constant artificial daylight. Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if (a) they are + or greater and (b) there are no erythema reactions in controls. - Challenge controls:
- - At each challenge with controls, 4 previously untreated animals were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the respective concentration.
- Positive control substance(s):
- no
- Positive control results:
- None
- Reading:
- other: challenge 1 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1 - after 1st induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 1 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1 - after 1st induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 2 - after 1st induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 2 - after 1st induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 3 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 3 - after 1st induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- other: other: challenge 3 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: other: challenge 3 - after 1st induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 3 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection Pine pumilionis stock S8690
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 3 - after 1st induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection Pine pumilionis stock S8690. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 3 - after 1st induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 % intradermal injection Pine pumilionis stock S8690
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 3 - after 1st induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 % intradermal injection Pine pumilionis stock S8690. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 1 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 1 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % topical application
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 1 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % topical application. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 % intradermal injection
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05 % intradermal injection. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.05 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % intradermal injection. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 % intradermal injection
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % topical application
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % topical application. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- other: challenge 2 - after 2nd induction treatment
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % topical application
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: challenge 2 - after 2nd induction treatment. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 % topical application. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the test conditions, Pine pumilionis oil classified as skin sensitiser "category 1" according to CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a skin sensitisation test, ten guinea pigs (males and females) were treated with test item, Pine pumilionis oil by intradermal injections (0.25 %) and were challenged approximately 2 weeks later by intradermal injection (0.1 %) and topical application (25 %). A second challenge with controls was made a further week later to clarify possible sensitisation seen at first challenge followed by a further cross- challenge with another test item: Pine pumilionis stock S8690. The induction procedure was then repeated and the animals challenged after two weeks. A final confirmatory challenge with controls was made. Preliminary irritation study was conducted in 4 males with intradermal injection (0.05-1 %) and topical application to determine the concentrations for main study.
1/10 guinea pigs sensitized after first induction treatment. 3/10 guinea pigs sensitized after second induction treatment.
Under the test conditions, Pine pumilionis oil induced weak sensitisation in guinea pigs.
- 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.
Some ingredients of Pine dwarf oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Pine dwarf oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008.
Referenceopen allclose all
- 1/10 guinea pigs sensitized after first induction treatment.
- 3/10 guinea pigs sensitized after second induction treatment.
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
Pine dwarf oil
Some ingredients of Pine dwarf oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Pine dwarf 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 positive reaction to Pine dwarf oil in 2 human patients with eczema(Paulsen, 2005). A guinea pig maximisation test is also available and showed 30% of positive reaction after two induction treatments.
Source: ECHA disseminated dossiers
- Pinene alpha:
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
- Pinene beta:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-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
- Terpinolene:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031_DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031.html
- Carene delta-3:
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead810f-31dc-543d-e044-00144f67d031/DISS-9ead810f-31dc-543d-e044-00144f67d031_DISS-9ead810f-31dc-543d-e044-00144f67d031.html
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
Pine dwarf oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Pine dwarf oil is classified as skin sensitizer:
- Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
No information was available regarding respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
