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Registration Dossier
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EC number: 279-317-3 | CAS number: 79828-43-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- EC Number:
- 279-317-3
- EC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Cas Number:
- 79828-43-6
- Molecular formula:
- C38H18Cl2CrN16O20S4.5Na
- IUPAC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 2.7 kg (approx. 15-16 weeks old). The acclimation period was 4 days under laboratory conditions after veterinary examination.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The opposite eye was right untreated and served as the control
- Amount / concentration applied:
- 0.1 g per animal
- Duration of treatment / exposure:
- examination at 1, 24, 48, 72 h after administration with a single dose.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- 1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. Body weights were measured on day 1 and at termination of test. The eyes of each animal were examined 1, 24, 48 and 72 h after administration. The corrosive properties of the test article and the colour of the treated eye were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean of 1 male and 2 females
- Time point:
- other: 1 - 72 hrs
- Score:
- 0.5
- Max. score:
- 13
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corrosion of cornea was observed at any of the measuring intervals.
- Other effects:
- In the area of application a severe bluish-black discolouration of the cornea and conjunctivae was observed. No acute toxicity symptoms were observed and no mortality occurred during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40210/A was found to cause a primary irritation scored of 0.5 when applied to the rabbit eye mucosa.
- Executive summary:
A key study was performed to determine the eye irritation of FAT 40210/A according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).
1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. A severe bluish-black discolouration of the cornea and conjunctivae of the treated eyes was observed which could be related to the colour proper to the test article. No corrosion was observed at any of the measuring intervals. The mean value of the scores for cornea, iris, conjunctivae chemosis is 0, otherwise the score for conjunctivae redness is 0.3 after 24 -72 h.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. FAT 40210/A showed a primary irritation score of 0.5 when applied to the rabbit eye mucosa, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
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