Registration Dossier
Registration Dossier
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EC number: 932-389-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study under GLP with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA method was not available by the time the study was conducted.
- Species:
- guinea pig
- Strain:
- other: Alderley Park, SPF-derived albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Unit, ICI Limited, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire
- Age at study initiation: 21-42 d
- Weight at study initiation: 300-400 g
- Housing: individually in solid-bottom plastic cages with sawdust bedding
- Diet (e.g. ad libitum): Frant FDI guinea pig diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 50-60%
- Air changes (per hr): 24 - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Dose finder: 100%, 75%, 50%, and 25% (w/v)
Main test (challenge): 75% and 50% (w/v) - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Dose finder: 100%, 75%, 50%, and 25% (w/v)
Main test (challenge): 75% and 50% (w/v) - No. of animals per dose:
- Control animals: 10
Test animals: 10 - Details on study design:
- RANGE FINDING TESTS: yes, with 100%, 75%, 50%, and 25% (w/v) in corn oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 10 animals
- Control group: 10 animals
- Site: scapular region
- Duration: 6 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 2 weeks after last induction exposure
- Exposure period: 6 h
- Test groups: 10 animals
- Control group: 10 animals
- Site: flank
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- 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.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Cyhalothrin is a skin sensitizer under the conditions of the study described.
- Executive summary:
Skin sensitizing potential of Cyhalothrin was assessed using the Buehler test on guinea pigs. GLP compliance was stated.
The test item Cyhalothrin Challenge of test and control animals with a 50% solution of cyhalothrin in corn oil caused faint erythema in 5 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. Challenge with a 75% solution in corn oil caused faint erythema in 2 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. No erythema were observed in any control animal.
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has to be classified as skin sensitizer on the basis of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitizing potential of the substance was assessed using the Buehler test on guinea pigs. GLP compliance was stated.
The test item Cyhalothrin Challenge of test and control animals with a 50% solution of cyhalothrin in corn oil caused faint erythema in 5 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. Challenge with a 75% solution in corn oil caused faint erythema in 2 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. No erythema were observed in any control animal.
Justification for classification or non-classification
The available data on Skin sensitization is considered reliable with restrictions but adequate for the classification and labelling.
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has to be classified as skin sensitizer on the basis of this study.
According to the criteria in Directive 2001/59/EC, Annex VI, 3.2, the substance is classified as R43, May cause skin sensitization by skin contact.
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