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EC number: 276-057-2 | CAS number: 71832-85-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 12 May 1981 / The study was performed before the guideline was published.
- Deviations:
- yes
- Remarks:
- period of treatment different to guideline, slightly different scoring system
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act
- Version / remarks:
- Sect.191.12 (February 1965)
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
- EC Number:
- 276-057-2
- EC Name:
- Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]
- Cas Number:
- 71832-85-4
- Molecular formula:
- C16H13ClN4O7S.1/2Ca
- IUPAC Name:
- calcium bis[4-({1-[(2-chlorophenyl)carbamoyl]-2-oxopropyl}diazenyl)-3-nitrobenzenesulfonate]
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 1 s eye held closed, 30 s treatment with open eye
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 5 male, 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water 200 ml
- Time after start of exposure: 30 sec
SCORING SYSTEM:
Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
The eye reactions were assessed as follows:
Score : Assessment
0 non irritant
>0 - 10 minimally irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 84 markedly irritant
> 84 extremely irritant
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 10
- Max. score:
- 80
- Remarks on result:
- other: washed and unwashed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 5
- Max. score:
- 80
- Remarks on result:
- other: 3 unwashed, 1 washed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 5
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: unwashed only
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 5
- Max. score:
- 20
- Remarks on result:
- other: washed and unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 20
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 5
- Max. score:
- 20
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 2
- Max. score:
- 20
- Remarks on result:
- other: washed and unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 1
- Max. score:
- 20
- Reversibility:
- fully reversible within: 6d
- Remarks on result:
- other: unwashed
- Irritant / corrosive response data:
- Conjunctiva.
A very slight to slight reaction was seen in all treated eyes one hour after the application of the compound. There was very little change by 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (one unwashed and 2 washed eyes) and 6 days (2 unwashed eyes).
Cornea.
Slight opacity with damage to the surface epithelium was seen in all treated eyes at one hour. This was still present in the 3 unwashed and one washed eye at 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (2 unwashed eyes) and 6 days (one unwashed eye).
Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is a minimal eye irritant but based on the results, there is no indication for an irritating effect based on GHS.
- Executive summary:
In the eye irritation test, similar to OECD 405, male and female New Zealand White rabbits were treated with the test substance as such.
Five male and one female were singly housed.
After the test substance was applied to one eye, the lid was closed for 1 second and left open for 30 seconds. Afterwards, the eye was washed with warm water and observed 1, 24, 48 and 72 hours after application. The right eye of each animal seved as control.
The slight reactions were reversible within 24 hours after application. Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.
The test substance is not considered to be eye irritant to rabbits.
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