Registration Dossier
Registration Dossier
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Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
EC number: 939-700-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 3, 1981 - August 10, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, occlusive treatment, 24 h exposure)
- Qualifier:
- according to guideline
- Guideline:
- other: (Proposed Guidelines of the United States Environmental Agency (EPA), §163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978).
- Principles of method if other than guideline:
- Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abdraded and intact skin for 24 hours. Scoring was recorded 24 h, 48 h, 72 h, 4 d and 7 d after application.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
- EC Number:
- 939-700-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred and raised in Ciba-Geigy premises
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: housed individually in metal cages
- Diet: standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL of test material on gauze patches of 2.5 x 2.5 cm - Duration of treatment / exposure:
- 24h
- Observation period:
- 7 days
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Site of exposure: back and flank of the rabbits
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: gauze patches covered with an impermeable material, fastened to the body of the rabbits with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h
SCORING SYSTEM:
- Evaluation was performed according to the Draize Scoring System.
- Calculation of the primary skin irritation index: the scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
- Assessment of irritation:
0
0.0-1.0 : minimal
1.1-2.0 : slight
2.1-4.0 : moderate
4.1-6.0 : marked
6.1-8.0 : extreme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
Any other information on results incl. tables
Results of Skin irritation (intact skin, 24 h exposure):
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Ery. |
Edema |
Ery. |
Edema |
Ery. |
Edema |
Ery. |
Edema |
Ery. |
Edema |
Ery. |
Edema |
|
24 h |
2 |
3 |
2 |
3 |
2 |
3 |
2 |
3 |
2 |
1 |
2 |
1 |
48 h |
2 |
3 |
4 |
3 |
3 |
3 |
2 |
3 |
2 |
2 |
2 |
1 |
72 h |
2 |
3 |
4 |
3 |
3 |
3 |
4 |
3 |
3 |
2 |
3 |
1 |
4 d |
2 |
3 |
4 |
3 |
3 |
2 |
4 |
2 |
2 |
2 |
3 |
2 |
7 d |
2 |
3 |
3 |
3 |
3 |
2 |
3 |
3 |
3 |
2 |
3 |
2 |
Mean value 24 + 48 + 72 h |
2.00 |
3.00 |
3.33 |
3.00 |
2.67 |
3.00 |
2.67 |
3.00 |
2.33 |
1.67 |
2.33 |
1.00 |
Mean value 24 + 48 + 72 h all animals |
2.55 |
2.44 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Ery.: Erythema
Mean reaction scores:
|
Mean reaction score |
|
|||
Time after exposure (hours) |
Erythema |
Edema |
Total |
||
Intact skin |
Abraded skin |
Intact skin |
Abraded skin |
||
24 |
2.0 |
2.3 |
2.3 |
2.7 |
|
72 |
3.2 |
3.3 |
2.5 |
2.7 |
|
Total |
5.2 |
5.6 |
4.8 |
5.8 |
21 |
Primary irritation index = 21.0 / 4 = 5.3
The test substance caused a marked irritation when applied to intact and abraded rabbit skin.
Up to 4 days after application, the surface of the erythema was greater than the site of application.
Slightly ischaemic areas were observed after 48 hours in 4/12 and after 3 and 4 days in 10/12 application sites.
After 7 days, practically all animals had cracked skin.
Both erythema and edema were observed with an average score between 2 and 3 (24 to 72h). The skin condition did not improve on day 4 and only barely improved on day 7, which was the last observation time point. The results for abraded skin were not considered for classification.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test article was found to cause a marked irritation when applied to intact and abraded rabbit skin.
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