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Registration Dossier
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EC number: 274-402-1 | CAS number: 70210-05-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. not GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978.
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- EC Number:
- 274-402-1
- EC Name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-05-8
- Molecular formula:
- C37H31N3O11S3.2Na
- IUPAC Name:
- sodium (E)-3-((2,4-bis(o-tolyloxy)phenyl)diazenyl)-4-hydroxy-5-(4-methylphenylsulfonamido)naphthalene-2,7-disulfonate
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Initial Body Weight Range: 2 - 3 kgsHusbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 22±3° C, relative humidity 55±15%; 12 hours light/day, approximately 15 air changes/h.Adaptation Period: 4 daysDiet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0-1 ml
- Duration of treatment / exposure:
- 30 s
- Observation period (in vivo):
- 7 dyas
- Number of animals or in vitro replicates:
- 3 male / 3 female
- Details on study design:
- The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 19
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 20
- Time point:
- other: mean score 24, 48, 72h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 21
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 22
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 23, 24
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 19,20,21
- Time point:
- other: mean score 24, 48, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: 22,23,24
- Time point:
- other: mean score 24, 48, 72h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 19,20
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 21
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 22
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 23
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 24
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 19,20,21
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 22
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 23
- Time point:
- other: mean score 24, 48, 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: 24
- Time point:
- other: 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- not irritant for eye
- Executive summary:
Method
The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed is the Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study", Federal Register, Vol. 43 No. 163 August 22, 1978.
The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit.
Results
The test material produced a minimal cornea irritation on 3/6 animals and minimal conjunctival irritation (redness) on 5/6 animals. . All treated eyes appeared normal at the 72-hour observation.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.
Therefore the substance does not meet the criteria to be classified as eye irritating.
In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).
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