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EC number: 266-767-0 | CAS number: 67601-05-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline conformant
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline conformant
- Justification for type of information:
- See read across justification document attached in section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Structural similar compouds (such as prenyl acetat) showed fales positive results in the LLNA or inconclusive results in in vitro studies.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN, Kreuzelweg 53, 5961 NM HORST, The Netherlands
- Age at study initiation: 3-4 weeks
- Weight at D0 of study: 241-295 g
- Housing: in groups of 2
- Diet: SAFE 106 ad libitum
- Water: ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 3)
- Humidity (%): 30-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of 100% (undiluted) test substance (MNIC determined in pre-study), control animals were treated with 0.5ml of liquid paraffin for sensitisation and challenged with 100% (undiluted) test substance.
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of 100% (undiluted) test substance (MNIC determined in pre-study), control animals were treated with 0.5ml of liquid paraffin for sensitisation and challenged with 100% (undiluted) test substance.
- No. of animals per dose:
- Total animals: 30
Group 1 (negative control): 10 female guinea pigs
Group 2 (treated with test substance): 20 female guinea pigs - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was carried out to dertermine the MNIC. Three guinea pigs were treated with concentrations of 100%, 75%, 50%, and 25% of test substance in liquid paraffin. Application was performed epicutaneously under occlusive dressing for 6 hours. Cutaneous reaction was determined 24h and 48h after removal of occlusive dressings. No irritating skin reaction could be found at all test concentrations. In view of these results, the concentration selected was 100% for the 3 inductions of the main study and the concentration selected was 100% (MNIC) for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure at D0, D7, D14
- Site: Scapular zone
- Duration: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (treated group), liquid paraffin (control group)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: D28
- Exposure period: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (MNIC) on the left flank or 0% test substance in liquid paraffin on the right flank
- Evaluation (hr after challenge): 24h, 48h after removal of occlusive dressing
Grading was perfomed according to OECD 406:
0 = No visible change
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
The number of animals showing visible cutaneous reactions were determined and recorded at 24 and 48 hours after challenge.
The classification "sensitising" results if at least 15% of test animals showed cutaneous reactions at the time of evaluation. The evaluation is based on the criteria of the OECD Harmonized Integrated Classification System in place on the date of report signature. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Discrete erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: no positive control reported
Induction phase:
No cutaneous reaction was recorded 24 hours after each induction in the treated group. No cutaneous reaction was recorded during the induction phase in the control group.
| Animals showing cutaneous reactions | |||
| 1st induction | 2nd induction | 3rd induction | |
| Control group (10 animals) | 0 | 0 | 0 |
| Treated group | 0 | 0 | 0 |
Challenge phase:
In the treated group (treatment concentration 100% of test item), a discrete erythema was noted in only one animal (1/20) at the reading time 24 hours. No macroscopic cutaneous reactions attributable to allergy were observed 48 hours after the removal of the occlusive dressing.
In the negative control group (treatment concentration of 100% liquid paraffin during induction phase and treatment concentration 100% of test item during challenge phase), no cutaneous reactions were observed at 24 or 48 hours after removal of occlusive dressing.
No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the area treated with liquid paraffin (vehicle).
The animals showed normal weight gain during the time of the study.
| Grading scale | ||||||||
| Groups | Reading time | Concentrations | 0 | 1 | 2 | 3 | % positive responses | % of animals sensitized |
| Control | 24 hours | 100% | 10 | 0 | 0 | 0 | 0 | |
| 48 hours | 100% | 10 | 0 | 0 | 0 | 0 | ||
| 24 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
| 48 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
| Treated | 24 hours | 100% | 19 | 1 | 0 | 0 | 5 | 5 |
| 48 hours | 100% | 20 | 0 | 0 | 0 | 0 | 0 | |
| 24 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 | |
| 48 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 | |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Structural similar compouds (such as prenyl acetat) showed fales positive results in the LLNA or inconclusive results in in vitro studies.
Test material
- Reference substance name:
- Citronellyl acetate
- EC Number:
- 205-775-0
- EC Name:
- Citronellyl acetate
- Cas Number:
- 150-84-5
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Citronellyl acetate
- Physical state: yellowish liquid
- Analytical purity: 97.1%
- Lot/batch No.: 00011277LO
- Expiration date of the lot/batch: 05 August 2016
- Storage condition of test material: room temperature, under light exclusion
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN, Kreuzelweg 53, 5961 NM HORST, The Netherlands
- Age at study initiation: 3-4 weeks
- Weight at D0 of study: 241-295 g
- Housing: in groups of 2
- Diet: SAFE 106 ad libitum
- Water: ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 3)
- Humidity (%): 30-70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of 100% (undiluted) test substance (MNIC determined in pre-study), control animals were treated with 0.5ml of liquid paraffin for sensitisation and challenged with 100% (undiluted) test substance.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Animals in treated group were sensitized and challenged with 0.5ml of 100% (undiluted) test substance (MNIC determined in pre-study), control animals were treated with 0.5ml of liquid paraffin for sensitisation and challenged with 100% (undiluted) test substance.
- No. of animals per dose:
- Total animals: 30
Group 1 (negative control): 10 female guinea pigs
Group 2 (treated with test substance): 20 female guinea pigs - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was carried out to dertermine the MNIC. Three guinea pigs were treated with concentrations of 100%, 75%, 50%, and 25% of test substance in liquid paraffin. Application was performed epicutaneously under occlusive dressing for 6 hours. Cutaneous reaction was determined 24h and 48h after removal of occlusive dressings. No irritating skin reaction could be found at all test concentrations. In view of these results, the concentration selected was 100% for the 3 inductions of the main study and the concentration selected was 100% (MNIC) for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure at D0, D7, D14
- Site: Scapular zone
- Duration: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (treated group), liquid paraffin (control group)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: D28
- Exposure period: 6h under occlusive dressing (50 x 25mm gauze patches hydrophilic Codex of 8-layer Gazin from Lohmann & Rauscher held in contact with the skin by means of 50mm wide hypoallergenic micropore adhesive tape from 3M and Blenderm from 3M)
- Concentrations: 100% test substance (MNIC) on the left flank or 0% test substance in liquid paraffin on the right flank
- Evaluation (hr after challenge): 24h, 48h after removal of occlusive dressing
Grading was perfomed according to OECD 406:
0 = No visible change
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
The number of animals showing visible cutaneous reactions were determined and recorded at 24 and 48 hours after challenge.
The classification "sensitising" results if at least 15% of test animals showed cutaneous reactions at the time of evaluation. The evaluation is based on the criteria of the OECD Harmonized Integrated Classification System in place on the date of report signature.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Discrete erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- other: no positive control reported
Any other information on results incl. tables
Induction phase:
No cutaneous reaction was recorded 24 hours after each induction in the treated group. No cutaneous reaction was recorded during the induction phase in the control group.
| Animals showing cutaneous reactions | |||
| 1st induction | 2nd induction | 3rd induction | |
| Control group (10 animals) | 0 | 0 | 0 |
| Treated group | 0 | 0 | 0 |
Challenge phase:
In the treated group (treatment concentration 100% of test item), a discrete erythema was noted in only one animal (1/20) at the reading time 24 hours. No macroscopic cutaneous reactions attributable to allergy were observed 48 hours after the removal of the occlusive dressing.
In the negative control group (treatment concentration of 100% liquid paraffin during induction phase and treatment concentration 100% of test item during challenge phase), no cutaneous reactions were observed at 24 or 48 hours after removal of occlusive dressing.
No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the area treated with liquid paraffin (vehicle).
The animals showed normal weight gain during the time of the study.
| Grading scale | ||||||||
| Groups | Reading time | Concentrations | 0 | 1 | 2 | 3 | % positive responses | % of animals sensitized |
| Control | 24 hours | 100% | 10 | 0 | 0 | 0 | 0 | |
| 48 hours | 100% | 10 | 0 | 0 | 0 | 0 | ||
| 24 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
| 48 hours | 0% | 10 | 0 | 0 | 0 | 0 | ||
| Treated | 24 hours | 100% | 19 | 1 | 0 | 0 | 5 | 5 |
| 48 hours | 100% | 20 | 0 | 0 | 0 | 0 | 0 | |
| 24 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 | |
| 48 hours | 0% | 20 | 0 | 0 | 0 | 0 | 0 | |
Applicant's summary and conclusion
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.
