Registration Dossier
Registration Dossier
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EC number: 427-670-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 June - 22 July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Details on test material:
- - Lot/batch No.: 6090
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: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 301 - 374 g
- Housing: singly or in pairs in solid-floor polypropylene vages furnished with woodflakes
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: a minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24 ºC
- Humidity (%): 54 - 68 %
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: topical
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Topical Induction : 50 % w/w in petroleum jelly
Concentration of test material and vehicle used for each challenge: Topical challenge: 50% and 25% w/w in petroleum jelly
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction: Topical Induction : 50 % w/w in petroleum jelly
Concentration of test material and vehicle used for each challenge: Topical challenge: 50% and 25% w/w in petroleum jelly
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
- The highest concentration of the test material producing only mild dermal irritation was selected for the topical induction stage of the main study.
- The highest concentration of the test material which produced no evidence of dermal irritation, and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals, vehicle alone was applied
- Site: clipped left flank under occlusive dressing
- Frequency of applications: 3 (days 0, 7 and 14)
- Concentrations: 50% w/w - test substance in petroleum jelly
B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Site: clipped right flank under occlusive dressing
- Concentrations: 25 and 50% w/w - test substance in petroleum jelly - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Pale green/yellow staining caused by the test material was noted at the
topical induction sites of two group animals after the second induction.
This did not prevent accurate assessment of skin response.
No skin reactions were noted at the challenge sites of the test or
control group animals at the 24 or 48 -hour observations.
Other observations:
Bodyweight gains of guinea pigs in the test group, between Day 0 and day
30, were comparable to those observed in the control group animals over
the same period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test substance did not meet the criteria for classification as a sensitiser according to EU labelling regulations.
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