Registration Dossier
Registration Dossier
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EC number: 274-437-2 | CAS number: 70210-40-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1974
- 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:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- Principles of method if other than guideline:
- Irritation potency of FAT 40062/A in the rabbit eyes of both sexes observed over a period of 7 days by treating with 0.1 g of the test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate
- EC Number:
- 274-437-2
- EC Name:
- Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate
- Cas Number:
- 70210-40-1
- Molecular formula:
- C19H15BrN4O8S2.2Na
- IUPAC Name:
- disodium 6-amino-5-({4-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): FAT 40062/A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Huntsman/ Ciba-Geigy
- Housing: Kept separately in V2A wire mesh cages
- Diet: NAFAG, Gossau SG (Rabbit food) ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males / 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 10 ml lukewarm water
- Time after start of exposure: 30 seconds
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Eyes rinsed and eyes not rinsed
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Eyes rinsed and eyes not rinsed
- Basis:
- mean
- Remarks:
- 6 rabbitts
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Eyes rinsed and eyes not rinsed
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40062/A is to be considered as non-irritant to the eye of rabbits.
- Executive summary:
FAT 40062/A, was evaluated for primary eye irritation after instillation of 0.1 g of the test substance into the conjunctival sac of the left eye of 6 rabbits (3 males/ 3 females) of the Russian breed, which were kept separately in V2A wire mesh cages. After application, the eyelids were held open for a few seconds. The right eye served as a control. Only rabbits showing normal ophthalmic findings were included in the test. The eyes of 3 of these 6 rabbits were rinsed with 10 ml of lukewarm water about 30 seconds after treatment. The treated eyes of all animals (washed and unwashed) were evaluated after 24 h and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
Therefore, FAT 40062/A is to be considered as non-irritant to the eye of rabbits.
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