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Registration Dossier
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EC number: 807-421-6 | CAS number: 260359-57-7
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Maximisation test has been performed in 2006.
Test material
Reference
- Name:
- Unnamed
- Test material form:
- liquid
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Purity : 96.7%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-7 weeks
- Weight at study initiation: male 303-398 g; female 262-314 g
- Housing: 2 to 3 guinea pigs of same sex per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 64-66
- Air changes (per hr): min 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5.0% v/v d-trans Allethrin in propylen glycol was selected for intrdermal injection.
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted d-trans Allethrin was selected for topical application during induction.
- Day(s)/duration:
- day 7
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted d-trans Allethrin was selected for topical application during challenge exposure.
- Day(s)/duration:
- day 21
- No. of animals per dose:
- 30 guinea pigs.
Control: 10 animals (5 males and 5 females)
Treatment group: 20 animals (10 males and 10 females) - Details on study design:
- The skin reactions were recorded post induction (intradermal injections/topical application) following the Draize method and at 24 and 48 hours post challenge treatment following the Magnusson and Kligman grading scale.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2 ml , 2 mercaptobenzothiazole
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2 ml , 2 mercaptobenzothiazole
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
Any other information on results incl. tables
Very slight erythema (8/20 guinea pigs), well-defined erythema (12/20 guinea pigs) and very slight oedema (18/20 guinea pigs) to slight oedema (1/20 guinea pigs) on day 1 following intradermal injecton.
Very slight erythema (13/20 guinea pigs) well-defined erythema (7/20 guinea pigs) and very slight oedema (13/20 guinea pigs) on day 10 on the left flank of the treatment group guinea pigs following topical application on day 7.
No skin reactions in the guinea pigs from the control group either on day 1 or day 10.
Any positive skin response at 24 or 48 hours post patch removal.
No clinical signs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A skin sensitisation rate of 0% at 24 and 48 hours post patch removal was observed using an adjuvant. d-trans Allethrin 75/25 is not considered as skin sensitiser to guinea pigs as the guinea pigs from the treatment group exhibited negative skin response.
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