Registration Dossier
Registration Dossier
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EC number: 278-133-0 | CAS number: 75214-65-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Remarks:
- source of read across endpoint record
- Adequacy of study:
- key study
- Study period:
- From July 27th to August 29th, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
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:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Experiment already available.
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRl, Biological Research laboratories ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland.
- Age at study initiation: 5 - 7 weeks.
- Weight at study initiation: 336 - 391 g.
- Housing: individually in Makrolon type-3 cages with autoclaved standard softwood bedding.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 24 °C
- Humidit:: 52 - 74 %
- Air changes: 10-15 per hr
- Photoperiod: 12 hrs dark / 12 hrs ligh
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 1
- No. of animals per dose:
- Control: 5 animals
Treated: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epidermal.
- Exposure period: 8 days.
- Test groups: 10 animals
- Control group: 5 animals
- Site: scapular area.
- Frequency of applications: 2 at a weeks distance.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Site: flank
- Concentrations: 25 %
- Evaluation: 24 and 48 hr after challenge. - Challenge controls:
- Opposite flank
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Group:
- positive control
- Remarks on result:
- other: no data available
Any other information on results incl. tables
Test Group Skin Response after challenge test article-treated, 25 % in distilled water
| Animal | Sex | erythema (24 h) | edema (24 h) | erythema (48 h) | edema (48 h) |
| 11 | male | 1 | 0 | 1 | 0 |
| 12 | male | 1 | 0 | 1 | 0 |
| 13 | male | 2 | 0 | 3 | 0 |
| 14 | male | 2 | 0 | 2 | 0 |
| 15 | male | 3 | 0 | 2 | 0 |
| 16 | male | 1 | 0 | 2 | 0 |
| 17 | male | 2 | 0 | 2 | 0 |
| 18 | male | 2 | 0 | 3 | 0 |
| 19 | male | 2 | 0 | 1 | 0 |
| 20 | male | 1 | 0 | 1 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens 1B, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Test item caused skin reactions after challenge in all treated animals
- Executive summary:
To assess the allergenic potential of test item in albino guinea pigs the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used.
Five males were used as control group and 10 males were used as test group.
The highest non-irritating test article concentration used for challenge application was 25 % in bi-distilled water.
All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and the test material is judged skin sensitising.
Conclusion
Skin sensitizer; more than 30 % responding at an intradermal induction dose higher than 1 %.
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