Registration Dossier
Registration Dossier
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EC number: 432-690-8 | 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:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested; GLP study using standard method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Maximisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
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: D. Hall Ltd; Burton on trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 313 - 403 g
- Housing: 1-2 per cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: > 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -21 C
- Humidity (%): 52-66 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal Induction: 10% w/v in deionised water
Topical Induction: 75% w/w in deionised water
Concentration of test material and vehicle used for each challenge:
Topical Challenge : 50% and 25% w/w in deionised water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal Induction: 10% w/v in deionised water
Topical Induction: 75% w/w in deionised water
Concentration of test material and vehicle used for each challenge:
Topical Challenge : 50% and 25% w/w in deionised water
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- MAIN STUDY
A1. INDUCTION EXPOSURE: intradermal
- No. of exposures: 1
- Exposure period: not applicable
- Control group: vehicle only
- Site: back of the neck/ shoulder
- Concentrations: 10 %
A2. INDUCTION EXPOSURE: epidermal
- No. of exposures: 1
- Exposure period: 48 h occlusive
- Control group: vehicle
- Site: back of the neck/shoulder
- Concentrations: 75 % in water
B. CHALLENGE EXPOSURE: epidermal
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Control group: same as treated
- Site: flank
- Concentrations: 25 % & 50 %
- Evaluation (hr after challenge): 24 h & 48 h - Positive control substance(s):
- yes
- Remarks:
- in separate studies positive results were generated with Mercaptobenzthiazole, hexyl-cinnamic aldehyde, and ethyl-amino-benzoate
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:
- 10
- 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: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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: test group. 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:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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: test group. Dose level: 25 %. 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:
- 5
- 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: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
Any other information on results incl. tables
Maximum concentration not causing
irritating effects in preliminary test: 50 %
Signs of irritation during induction:
Intradermal Induction:
Very slight erythema was noted at all test group sites at the 24 and
48-hour observations. No signs of skin irritation were noted at the
control sites at either the 24 or 48-hour observations.
Topical Induction:
Very slight erythema was noted at all test group sites at the 1-hour
observation and persisted at one test site at the 24-hour observation.
Residual test material was present at all test sites at the 1 and
24-hour observations. Very slight erythema was noted at one control site
at the 1-hour observation.
Evidence of sensitisation of each challenge concentration:
None.
Other observations:
Pale yellow coloured staining was noted at all test and control sites at
the 24 and 48-hour observations at the 50% w/w dilution and one test and
one control site at the 25% w/w dilution.
All animals showed expected gain in bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The analogue substance 1 (refer to IUCLID chaper 13) did not cause skin sensitisation in a maximisation test using 50 % as challenge concentration
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