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: -
Eye irritation
Administrative data
- Endpoint:
- eye 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 guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation)
- 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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PP 126/1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing:individually in metal cages, numbered by ear tags
- Diet: NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as a control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
Evaluation of the eye reactions according to the Draize Scoring System.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Eyes of 3/6 animals were rinsed after approx. 30 seconds.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 3/6 rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 3/6 rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed
Any other information on results incl. tables
Results: Eye irritation
|
Eye treatment |
not rinsed |
rinsed (after 30 s) |
||||
Animal no. |
1 |
2 |
3 |
4 |
5 |
6 |
|
24 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
1 |
2 |
1 |
1 |
1 |
|
Chemosis |
0 |
1 |
1 |
1 |
1 |
1 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
1 |
0 |
1 |
1 |
0 |
0 |
|
Chemosis |
0 |
0 |
1 |
1 |
1 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
1 |
1 |
1 |
0 |
0 |
|
Chemosis |
0 |
0 |
1 |
1 |
1 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 d |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
1 |
1 |
1 |
1 |
0 |
|
Chemosis |
0 |
0 |
1 |
1 |
1 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
7d |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
1 |
1 |
0 |
0 |
1 |
|
Chemosis |
0 |
0 |
0 |
0 |
1 |
1 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean value 24, 48, 72 h |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0.67 |
0.67 |
1.33 |
1.00 |
0.33 |
0.33 |
|
Chemosis |
0 |
0.33 |
1.00 |
1.00 |
1.00 |
0.33 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation below the level of regulatory significance when applied to the rabbit eye mucosa.
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