Registration Dossier
Registration Dossier
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EC number: 807-560-2 | CAS number: 123944-63-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The information is provided from a reliable secondary source.
Data source
Reference
- Reference Type:
- other: secondary source
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- - the original study was conducted in 1975
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: Blue powder
- Name of test material (as cited in study report): Sanolin Blue EHRL
- Other name(s): C.I. Acid Blue 182
- Marketing names: Sanolin Blue E-HRL, Sandolan Blue E-HRL 180, Sandolan Blue E-HRL, Alizarinlichtblau HRL
- Degree of purity: High
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.05
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material is non-irritating to the eye.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 42. These methods are similar to those outlined in the standardised guideline OECD 405.
Six Albino rabbits were exposed to the test material and observed for 7 days. Ocular reactions were scored using the Draize method. Eyes were evaluated at 24, 48 and 72 hours and animals continued to be observed for the remainder of the 7 days.
Redness of the conjunctiva was observed in 3 animals, which persisted up to 7 days in 2 animals. Chemosis was seen in 1 animal, which resolved by 48 hours.
Under the conditions of this study, the test material is non-irritating to the eye.
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