Registration Dossier
Registration Dossier
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EC number: 212-668-2 | CAS number: 842-07-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73.
- Principles of method if other than guideline:
- Primary eye irritation of 1-(phenylazo)-2-napthol was evaluated in rabbits according to Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73. Guidelines
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-phenylazo-2-naphthol
- EC Number:
- 212-668-2
- EC Name:
- 1-phenylazo-2-naphthol
- Cas Number:
- 842-07-9
- Molecular formula:
- C16H12N2O
- IUPAC Name:
- 1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol
- Test material form:
- solid
- Details on test material:
- Name of test material (as cited in study report): C.I Solvent Yellow 14
Molecular formula: C16H12N2O
Molecular weight:248.284 g/mol
Smiles notation :c12c(\N=N\c3ccccc3)c(ccc1cccc2)O
InChl:1S/C16H12N2O/c1915111012645914(12)16(15)1817137213813/h111,19H/b1817+
Physical State: Solid
Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): C.I Solvent Yellow 14
Molecular formula: C16H12N2O
Molecular weight: 248.284 g/mol
Smiles notation: c12c(\N=N\c3ccccc3)c(ccc1cccc2)O
InChI: 1S/C16H12N2O/c1915111012645914(12)16(15)1817137213813/h111,19H/b1817+
Physical State: Solid
Substance type: Organic
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 24, 48 and 72 hours
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test chemical was instilled into the right eye of the rabbits
Scoring method: Draize, J .H. (1959)
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.34
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Conjunctival redness and secretion was observed in all the rabbits till 72 hours.
Any other information on results incl. tables
Results of Primary Eye Irritation test:
|
24 hours |
48 hours |
72 hours |
|||||||||||||||
Right Eye |
Rabbit number |
Rabbit number |
Rabbit number |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
|
1. Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A. Cloudiness |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
a= A*B*5 (Max =50) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2. Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
b= Wert*5 (Max = 10) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3. Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A. Redness |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
B. Swelling |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. Secretion |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
c= (A+B+C)*2 (Max = 20) |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
0 |
0 |
2 |
2 |
0 |
2 |
2 |
0 |
2 |
0 |
Total = a + b+ c (Max = 110) |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
0 |
0 |
2 |
2 |
0 |
2 |
2 |
0 |
2 |
0 |
Primary Eye Irritation Score : φ18 = 1.34
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The Primary Irritation Score for eye irritation in rabbits was 1.34.
Based on the scores, 1-(phenylazo)-2-napthol can be considered as not irritating to rabbit eyes. - Executive summary:
Primary eye irritation of 1-(phenylazo)-2-napthol was evaluated in rabbits according to Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73. Guidelines.
6 rabbits were used for the study.Undiluted test chemical was instilled into the right eye of the rabbit and the effects were observed.The reactions were observed at 24 ,48 and 72 hours and scored according to Draize method.Conjunctival redness and secretion was observed in all the rabbits till 72 hours.
The Primary Irritation Score for eye irritation in rabbits was 1.34.
Based on the scores, 1-(phenylazo)-2-napthol can be considered as not irritating to rabbit eyes.
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