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EC number: 400-320-4 | CAS number: 94933-05-8
- Life Cycle description
- Uses advised against
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- Aquatic toxicity
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- Irritation / corrosion
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![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 1983
- 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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- Artificial lighting sequence is 10 hours dark, 14 hours light
- GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 400-320-4
- EC Name:
- -
- Cas Number:
- 94933-05-8
- Molecular formula:
- not applicable
- IUPAC Name:
- chromium(3+) trisodium bis(2-(2-{4-hydroxy-2-oxido-3-[2-(5-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl)benzoate)
- 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: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, England
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.44 to 2.70 kg
- Gender: female; nulliparous and non-pregnant
- Housing: individual grid floor cages
- Diet: ad libitum; SQC Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex, England
- Water: ad libitum (analytical test report demonstrates suitability)
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 21 °C
- Humidity: 48 to 62 %
- Air changes per hour: not specified
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 rabbits (female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h
SCORING SYSTEM: Grading of Ocular Lesions, OECD Guideline for the Testing of Chemicals, Test No. 405: Acute Eye Irritation/Corrosion, 2017
- Irritation scores of each animal at 1, 24, 48 and 72 hours and 7 days were measured.
- The scoring systems found in "Any other information on materials and methods", below, was used to assess eye damage parameters.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corrosive effects were observed.
- Other effects:
- COLOURATION
Hair adjacent to the treated sites was stained brown by the test item.
Any other information on results incl. tables
Table 1: Individual conjunctivae, iris and corneal irritation scores.
Animal number and gender | Body weight (kg) | Time after treatment | Conjunctiva | Iris | Cornea | Score | Total score | |||||
Redness | Chemosis | Discharge | Opacity | Area | (a+b+c)×2 | d×5 | e×f×5 | |||||
a | b | c | d | e | f | |||||||
573F | 2.44 | 1 hour | 2 | 2 | 1 | 0 | 0 | 0 | 10 | 0 | 0 | 10 |
1 day | 2 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 4 | ||
2 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
3 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
574F | 2.70 | 1 hour | 2 | 2 | 2 | 0 | 0 | 0 | 12 | 0 | 0 | 12 |
1 day | 2 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 4 | ||
2 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
3 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
575F | 2.64 | 1 hour | 2 | 1 | 1 | 0 | 0 | 0 | 8 | 0 | 0 | 8 |
1 day | 2 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 4 | ||
2 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
3 days | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2: Mean eye irritation scores.
Time after treatment | Mean scores | |||
Conjunctiva (max 20) | Iris (max 10) | Cornea (max 80) | Mean total scores (max 110) | |
1 hour | 10.0 | 0.0 | 0.0 | 10.0 |
1 day | 4.0 | 0.0 | 0.0 | 4.0 |
2 days | 2.0 | 0.0 | 0.0 | 2.0 |
3 days | 2.0 | 0.0 | 0.0 | 2.0 |
7 days | 0.0 | 0.0 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified accoring to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The test item was not found to be an Eye Irritant or an Eye Corrosive.
- Executive summary:
The eye irritation potential of the test item was evaluated in an experimental study comparable to the OECD Guideline 405 (1981). 100 mg of moistened test item was administered to the inside of the lower, left eyelid of three female New Zealand albino rabbits and rinsed with warm water after 24 hours. Animals were monitored for corneal capacity, iritis, conjunctival redness and oedema at 1, 24, 48 and 72 hours and 7 days after the application of the test item. The right eye received no treatment, therefore was considered a negative control.
Mean (24, 48 and 72 hour) conjunctival redness scores were 1.33 in all three animals, however this effect was reversible within 7 days. Corneal opacity, iritis and chemosis scores were 0 at all time points and for all three animals. Slight brown staining of the hair adjacent to the eye was observed. No corrosive effect was observed.
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