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Registration Dossier
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EC number: 603-373-3 | CAS number: 129909-90-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 1994 to 24 March 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- (1989)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- EC Number:
- 603-373-3
- Cas Number:
- 129909-90-6
- Molecular formula:
- C10H19N5O2
- IUPAC Name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- Reference substance name:
- Technical Grade MKH 3586
- IUPAC Name:
- Technical Grade MKH 3586
- Details on test material:
- - Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige powder
- Analytical purity: 97.8 - 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Single application (unwashed)
- Observation period (in vivo):
- 1, 24, 48, 72 hrs
- Number of animals or in vitro replicates:
- 6 males/dose group
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: All time points
- Max. score:
- 0
- Reversibility:
- other: No effects observed to the cornea
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: All time points
- Max. score:
- 0
- Reversibility:
- other: No effects observed to the iris
- Irritation parameter:
- conjunctivae score
- Basis:
- other: discharge
- Time point:
- other: 1 hr
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- other: chemosis
- Time point:
- other: 1 and 24hrs
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- other: redness
- Time point:
- other: 1, 24 and 48hrs
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
Any other information on results incl. tables
OBSERVATIONS:
Clinical / eye:
No clinical signs of toxicity or other non-ocular lesions were observed. The cornea and iris showed no lesions or other signs of irritation in any animal. Conjunctival discharge (grade 2) was observed in 3/6 animals 1 hour post dosing and resolved in all of the affected animals by 24 hours post dosing. Chemosis (grade 1) was observed in 6/6 animals 1 hour post dosing. Resolving in 5/6 animals by 24 hours with the final animal returning to normal by 48 hours. Conjunctival redness (grade 1) was observed in 6/6 animals at 1 hour and resolved in 3/6 animals by 48 hours and the other 3/6 by 72 hours (refer to Table 7.3.2).
Table 7.3.2: Eye irritation scores according to the modified Kay and Calandra scoring system
Animal |
Time |
Cornea |
Iris |
Conjunctiva |
||
Redness |
Chemosis |
Discharge |
||||
Rabbit 1 |
1 |
0 |
0 |
1 |
1 |
2 |
24 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Rabbit 2 |
1 |
0 |
0 |
1 |
1 |
0 |
24 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Rabbit 3 |
1 |
0 |
0 |
1 |
1 |
0 |
24 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Rabbit 4 |
1 |
0 |
0 |
1 |
1 |
2 |
24 |
0 |
0 |
1 |
1 |
0 |
|
48 |
0 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Rabbit 5 |
1 |
0 |
0 |
1 |
1 |
0 |
24 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Rabbit 6 |
1 |
0 |
0 |
1 |
1 |
2 |
24 |
0 |
0 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
|
Mortality:
All animals survived to the scheduled necropsy
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, MKH 3586 is classified as a minimal irritant to the rabbit eye.
- Executive summary:
In a primary eye irritation study, 0.1 mL MKH 3586 was instilled into the conjunctival sac of the left eye of six young male adult New Zealand White rabbits. The right eye acted as a untreated control. Each treated eye was evaluated for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours following treatment using the modified Kay and Calandra scoring system
No clinical signs of toxicity or other non-ocular lesions were observed. The cornea and iris showed no lesions or other signs of irritation. The test material caused transient conjunctival discharge (grade 2) as well as chemosis (grade 1) and redness (grade 1). These signs of irritation were present 1 hour after treatment and had resolved in all animals by 72 hours.
Based on the results of this study, MKH 3586 is classified as a minimal irritant to the rabbit eye.
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