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Registration Dossier
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EC number: 269-197-0 | CAS number: 68189-39-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from authoritative databases
Data source
Reference
- Reference Type:
- other: Authoritive databse
- Title:
- Eye irritation Test for CAS no: 5858-81-1
- Author:
- IFA GESTIS
- Year:
- 2 017
- Bibliographic source:
- GESTIS SUBSTANCE Database (information system in hazardous substance of the Berufsgenossenscheftn), 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The local eye irritative potential of test chemical D & C Red No. 6 (CAS no: 5858-81-1) was investigated in rabbits’ eye to assess the degree of eye irritancy caused by the chemical.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 227-497-9
- EC Name:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5858-81-1
- Molecular formula:
- C18H14N2O6S.2Na
- IUPAC Name:
- disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
Substance Type: Organic
Physical State: Solid
SMILES:Cc1ccc(N=Nc2c3ccccc3cc(C(=O)O{-}.[Na]{+})c2O)c(S(=O)(=O)O{-}.[Na]{+})c1
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6/Lithol Rubine B (LRB)
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
Substance Type: Organic
Physical State: Solid
SMILES:Cc1ccc(N=Nc2c3ccccc3cc(C(=O)O{-}.[Na]{+})c2O)c(S(=O)(=O)O{-}.[Na]{+})c1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
Test system
- Vehicle:
- other: aqueous suspension
- Controls:
- not specified
- Amount / concentration applied:
- 2 instillations of 10% (0.2ml)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 4 weeks
- Number of animals or in vitro replicates:
- no data available
- Details on study design:
- - Area of exposure: conjunctival sac of rabbits
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 weeks
- Reversibility:
- fully reversible
- Remarks:
- 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Only minimal irritative effects after 2 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as not irritating to the rabbits’ eye.
- Executive summary:
The local eye irritative potential of test chemical D & C Red No. 6 (CAS no: 5858-81-1)was investigated in rabbits’ eye to assess the degree of eye irritancy caused by the chemical.
Each rabbit received 2 installation of 0.2 ml of a 10% D & C Red No. 6 aqueous suspension into the conjunctival sac of rabbits 5 times per week for 4 weeks.
The chemical producedonly minimal irritative effects after 2 hours which could not confirmed the irritation potential. Hence, on the basis of findingsthe chemical D & C Red No. 6 (CAS no: 5858-81-1)can be considered as not irritating to the rabbits’ eye.
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