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EC number: 201-983-0 | CAS number: 90-30-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-06-10 to 1987-07-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- A modified procedure from the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 26 8-276, 1969; Contact Dermatitis 6, 46-50, 1980), recommended in the OECD guidelines 1981 and in the EEC directive 7 9/831, was performed. The method was selected on account of its suitability for final formulations or for compounds which are not injectable on account of their insolubility in standard vehicles.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- in vivo guinea pig studies were available.
Test material
- Reference substance name:
- N-1-naphthylaniline
- EC Number:
- 201-983-0
- EC Name:
- N-1-naphthylaniline
- Cas Number:
- 90-30-2
- Molecular formula:
- C16H13N
- IUPAC Name:
- N-phenylnaphthalen-1-amine
- Details on test material:
- - Name of test material (as cited in study report): N-phenyl-alpha-napthylamine (TK 11330)
- Physical state: solid; insoluble in water
- Analytical purity: comm. grade
- Batch No.: 9-10-86
- Storage condition of test material: room temperature
- Other: Test material received: 28. April 1987
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, 4334 Sisseln, Switzerland
- Age at study initiation: 10 weeks old
- Weight at study initiation: 302 - 432 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG No.846, Gossau SG
- Water (e.g. ad libitum): drinking water is examined periodically by the IWB (Industrielle Werke Basel)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- First induction: approx. 0.4 g of 10 % test material in vaseline
Second induction: approx. 0.4 g paste of 10 % test material in vaseline - Day(s)/duration:
- 24 h epicutaneous
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- approx. 0.2 g paste of 3 % test material in vaseline
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: The concentration of the test compound for the induction and challenge periods were determined on separate animals.
MAIN STUDY
INDUCTION EXPOSURE: first induction
0.1 mL of a freshly prepared adjuvant saline mixture (1:1) was injected intracutaneously at 4 sites into the animals neck skin. The test substance was incorporated in vaseline and applied on a filterpaper patch over the adjuvant injection sites (patch 2x4 cm; occluded adminstration for 24 hours); approx. 0.4 g of 10 % test material in vaseline.
INDUCTION EXPOSURE: second induction
One week later the test substance was again incorporated in vaseline and applied on the adjuvant injection sites of the first week. The filterpaper patches were administered occlusively for 48 hours; approx. 0.4 g paste of 10 % test material in vaseline.
CHALLENGE EXPOSURE
2 weeks after the epidermal induction application the animals were tested on the flank with the test substance in vaseline and the vehicle alone (patch 2x2 cm; occluded administration for 24 hours); approx. 0.2 g paste of 3 % test material in vaseline.
Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritatant concentration of the test compound in adjuvant treated animals.
Separate animals were treated with the test item for the evaluation of the primary irritation threshold concentration. Concentrations of 1, 3, 10 and 30 % in vaseline were tested. Erythema reactions were observed at 10 and 30 %. No erythema was induced at the lower concentrations. Therefore, 3 % was used as the maximal subirritant concentration for the challenge application. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not determinable because of methodological limitations
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not determinable because of methodological limitations
Any other information on results incl. tables
Number of positive animals per group after occlusive epicutaneous application:
| 24 hours | 48 hours | ||
| Control group | vehicle control | 0/20 | 0/20 |
| test compound | 0/10 | 0/10 | |
| test group | vehicle control | 0/20 | 0/20 |
| test compound | 18/20 | 18/20 |
Under the experimental test conditions employed, 90% of the animals showed skin reactions (erythema and edema) 24 and 48 hours after removing of the dressings.
Individual readings of the test group animals
DRAIZE Score 24 hours after removal of the dressing with the test compound:
| Male animal | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Erythema score | 1 | 0 | 2 | 1 | 2 | 2 | 1 | 2 | 1 | 1 |
| Edema score | 2 | 0 | 3 | 1 | 3 | 2 | 2 | 3 | 2 | 1 |
| Female animal | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Erythema score | 3 | 2 | 1 | 0 | 2 | 1 | 2 | 1 | 1 | 1 |
| Edema score | 3 | 2 | 0 | 0 | 3 | 1 | 2 | 1 | 1 | 1 |
DRAIZE Score 48 hours after removal of the dressing wih the test compound
| Male animal | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Erythema score | 1 | 0 | 2s | 1 | 2s | 1 | 1 | 1 | 1 | 1 |
| Edema score | 1 | 0 | 2 | 1 | 3 | 1 | 1 | 2 | 1 | 1 |
| Female animal | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Erythema score | 2s | 2s | 1 | 0 | 1s | 1s | 2s | 1s | 1 | 1 |
| Edema score | 2 | 2 | 0 | 0 | 2 | 1 | 2 | 1 | 1 | 1 |
s = scaling
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based on EU GHS criteria
- Conclusions:
- 90 % of the animals were sensitized under the experimental conditions employed.
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