Registration Dossier
Registration Dossier
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EC number: 220-028-9 | CAS number: 2610-11-9
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- EC Number:
- 220-028-9
- EC Name:
- Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 2610-11-9
- Molecular formula:
- C29H21N5O8S2.2Na
- IUPAC Name:
- disodium 7-benzamido-4-hydroxy-3-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Body weight: from 1.5 to 2 kg- Housing: individually in metal cage - Diet: NAFAG, Gossau SG, rat food ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 h light / 14 h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye was not treated and served as an untreated control.
- Amount / concentration applied:
- The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for one second.
- Duration of treatment / exposure:
- 30 sec
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- six rabbits (3 male and 3 female)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 6
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index as the measure of the acute irritation to the eye of rabbits was found to be 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
The primary irritation effect was assested following the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
The result does not show irritation on rabbit eye following the indicated guideline and the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.
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