Registration Dossier
Registration Dossier
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EC number: 268-655-7 | CAS number: 68132-91-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- 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:
- 1 974
Materials and methods
- Principles of method if other than guideline:
- Skin Sensitisation (Ear/Flank Method, Stevens (1967))
Seven male guinea pigs were used for this test. On days 0, 1 and 2 of the test, 0.1 ml of the test agent was applied to the outer surface of the ears of four animals only. On day 6, 0.2 ml of the challenge solutions in dimethyl formamide (DMF) were applied topically to the clipped flanks of all seven animals. On day 7 the erythema which had developed at each site was rated on a 5-point scale. In the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitisation; that present in the controls, denoted simple primary irritation. - GLP compliance:
- no
- Type of study:
- other: Stevens ear/flank test
- Justification for non-LLNA method:
- The test method was not available at the time of testing
Test material
- Reference substance name:
- Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
- EC Number:
- 268-655-7
- EC Name:
- Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
- Cas Number:
- 68132-91-2
- Molecular formula:
- C38H20Cl2CuN14O18S5. H. 5Na C38H21Cl2CuN14Na5O18S5
- IUPAC Name:
- Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test Substance : Procion Blue H-E RD = Reactive Blue 160
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Zeneca Alderly Park
- Weight at study initiation: 300 to 500 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: DMF
- Concentration / amount:
- 10% 0.1 mL for each ear
- Day(s)/duration:
- 3 consecutive days
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: DMF
- Concentration / amount:
- 0.2 mL 0.1% and 10%
- Day(s)/duration:
- 1
- No. of animals per dose:
- 3 control
4 treated - Details on study design:
- Seven male guinea pigs were used for this test. On days 0, 1 and 2 of the test, 0.1 ml of the test agent was applied to the outer surface of the ears of four animals only. On day 6, 0.2 ml of the challenge solutions in dimethyl formamide (DMF) were applied topically to the clipped flanks of all seven animals. On day 7 the erythema which had developed at each site was rated on a 5-point scale. In the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitisation; that present in the controls, denoted simple primary irritation.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 3
Any other information on results incl. tables
No evidence of erythema was produced by any of the challenge applications.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-sensitiser
- Conclusions:
- The test substance did not show any skin senstising properties
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