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EC number: 915-761-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June, 1980 to 23 June, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)
- EC Number:
- 263-444-6
- EC Name:
- Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)
- Cas Number:
- 62163-53-5
- Molecular formula:
- C17H18N6.C2H6O4S
- IUPAC Name:
- diethyl sulfate - N-benzyl-N-methyl-4-[(1-methyl-1H-1,2,4-triazol-5-yl)diazenyl]aniline (1:1)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test material received May 2, 1980
Additional identification: Physical appearance: liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22±2 °C, at a relative humidity of 55±10 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed after 30 seconds
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days for the rabbit with symptoms
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation; 2 out of 3 rabbits had no irritation reaction in iris at any observation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation
Any other information on results incl. tables
Primary irritation index
Time after exposure days |
mean reaction score |
|||||
unrinsed eyes (A) |
rinsed eyes (B) |
|||||
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
|
1 |
26.7 |
10 |
18 |
11.7 |
1.7 |
15.3 |
2 |
40 |
10 |
18.7 |
25 |
3.3 |
17.3 |
3 |
40 |
10 |
18.7 |
30 |
3.3 |
17.3 |
4 |
46.7 |
10 |
18.7 |
30 |
3.3 |
17.2 |
7 |
46.7 |
10 |
18.7 |
30 |
3.3 |
14.7 |
subtotal |
200.1 |
50 |
92.8 |
126.7 |
14.9 |
81.9 |
total |
342.9 |
223.5 |
||||
primary irritation index in unrinsed eyes
A = 342.9 : 5 = 68.6
primary irritation index in rinsed eyes
B = 223.5 : 5 = 44.7
effect of rinsing
R = A/B = 68.6/44.7 = 1.5
Scores for individual rabbits
Animal no.s |
|
scores |
||||
24 h |
48 h |
72 h |
Day 4 |
Day 5 |
||
127 (Unrinsed) |
Corneal opacity |
3 |
3 |
3 |
4 |
4 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
4 |
4 |
4 |
4 |
|
128 (Unrinsed) |
Corneal opacity |
2 |
3 |
3 |
3 |
3 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
2 |
3 |
3 |
3 |
|
Chemosis |
3 |
3 |
3 |
3 |
3 |
|
129 (Unrinsed) |
Corneal opacity |
3 |
3 |
3 |
3 |
3 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
3 |
3 |
3 |
3 |
|
130 (Rinsed) |
Corneal opacity |
1 |
1 |
1 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
2 |
2 |
2 |
2 |
2 |
|
Chemosis |
3 |
3 |
3 |
3 |
2 |
|
131 (Rinsed) |
Corneal opacity |
1 |
1 |
1 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctival redness |
2 |
2 |
2 |
2 |
2 |
|
Chemosis |
3 |
3 |
3 |
3 |
2 |
|
132 (Rinsed) |
Corneal opacity |
2 |
3 |
4 |
4 |
4 |
Iris |
1 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
4 |
4 |
4 |
4 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Instillation of FAT 31016/F in eye, leads to irreversible effects on the eyes.
- Executive summary:
Eye irritation potential of FAT 31016/F was evaluated in a study conducted as per the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female New Zealand White rabbits. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥3 for 2 out of 3 rabbits which did not receive rinsing. Also the iris was scored to be =2 in all 3 rabbits which did not receive rinsing. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.
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