Registration Dossier
Registration Dossier
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EC number: 939-703-0 | CAS number: 1474044-75-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 9; 1990 - November 9, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- CIBA-GEIGY Limited, Toxicology Services, Dermatotoxicology, 4002 Basel / Switzerland
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid maximization study with guinea pigs is available, no further animal studies are necessary
Test material
- Reference substance name:
- Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine
- EC Number:
- 939-703-0
- Cas Number:
- 1474044-75-1
- Molecular formula:
- C16H19N - C28H43N (main constituents)
- IUPAC Name:
- Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine
- Details on test material:
- - Analytical purity: no data
- Physical state: liquid (soluble in water)
- Storage conditions: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba Geigy Ltd., Tierfarm, Stein, Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 363 g to 461 g
- Housing: individually in Macrolon cages (type 3)
- Diet: standard guinea pig pellets, NAFAG No. 845, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 1%
- Day(s)/duration:
- 1 week
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30%
- Day(s)/duration:
- 48h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h
- No. of animals per dose:
- 20 (10 males, 10 females)
- Details on study design:
- RANGE FINDING TESTS:
1, 3 and 5% suspensions of the test substance in saline was tested intradermally in separate animals. Because necrosis were induced with the 3 and 5% concentrations, the 1% concentration was used for the intradermal induction injections.
30, 10 and 3% of the test substance in vaseline have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration. The tested concentrations did not induce erythema reactions. 30% was therefore selected for the epidermal induction application. 10% was used as subirritant concentration for the challenge application because a higher concentration may lead to nonspecific reactions in adjuvant treated animals.
MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal, first week)
- No. of exposures: 3 pairs of injections (0.1 mL per injection) were made simultaneously
- Test groups: a) adjuvant/saline mixture 1:1 (v/v); b) test article in physiological saline (w/v); c) test article in the adjuvant saline mixture (w/v)
- Control group: as test group, but without test article
- Site: shaved neck
- Concentrations: 1% in physiological saline
A2. INDUCTION EXPOSURE (epidermal, second week)
- No. of exposures: one week after intradermal induction, 1 epidermal induction with test substance (patch: 2 x 4 cm, occlusive)
- Exposure period: 48 h
- Test groups: 0.4 g test substance in vaseline
- Control group: vehicle only
- Site: same site as intradermal induction (neck)
- Concentrations: 30% in vaseline
- Preparation: The application sites were pretreated the day before with 10% sodium lauryl sulfate.
B. CHALLENGE EXPOSURE (week 5)
- No. of exposures: 2 epidermal challenges (challenge and rechallenge) with test substance in vaseline and the vehicle alone (patch: 2 x 2 cm, occlusive)
- Exposure period: 24 h
- Test groups: vehicle alone and test article
- Control group: vehicle alone and test article
- Site: flank
- Concentrations: 10% in vaseline
- Evaluation (hr after challenge): 24 and 48 h after removal of the dressing
A second challenge (same procedure) was performed one week after the first challenge to confirm the results.
OTHER: body weight was recorded at the start and end of the test. - Positive control substance(s):
- yes
- Remarks:
- Phenylendiame (strain is checked every 6 months)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results of test group after challenge and rechallenge treated with 10% of the test article
Males |
Animal number |
||||||||||
Challenge |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
24 h |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
Re-Challenge |
|
||||||||||
24 h |
Erythema |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
|
48 h |
Erythema |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2s |
0 |
0 |
Edema |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
|
Females |
Animal number |
||||||||||
Challenge |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
24 h |
Erythema |
1 |
2 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
Edema |
1 |
2 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
48 h |
Erythema |
1 |
2s |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
Edema |
1 |
2 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
Re-Challenge |
|
||||||||||
24 h |
Erythema |
1 |
2 |
0 |
0 |
2 |
2 |
0 |
1 |
0 |
1 |
Edema |
1 |
2 |
0 |
0 |
2 |
2 |
0 |
1 |
0 |
2 |
|
48 h |
Erythema |
1s |
2s |
0 |
0 |
1s |
1 |
0 |
1s |
0 |
1s |
Edema |
1 |
2 |
0 |
0 |
2 |
2 |
0 |
1 |
0 |
2 |
|
s = scaling
Body weight gain was in the normal range in all groups.
After challenge 25% of the animals showed positive results. After the rechallenge 45% of the animals showed positive results, indicating that the test substance has a sentitising potential.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- 25 % of the animals were sensitised after the standard challenge application. After a second challenge the sensitising potential of the test substance was confirmed; the incidence of positive animals increased to 45 %. As a result, the test article requires classification for skin sensitization according to CLP and DSD.
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