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EC number: 412-640-1 | CAS number: 84632-50-8
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-06-24 to 1992-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted Sept. 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the LLNA did not yet exist.
Test material
- Reference substance name:
- -
- EC Number:
- 412-640-1
- EC Name:
- -
- Cas Number:
- 84632-50-8
- Molecular formula:
- C20 H10 N4 O2
- IUPAC Name:
- 3-[4-(3-cyanophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 99%
- Appearance: orange powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: approximately six to seven weeks
- Weight at study initiation: 295 to 342 g
- Housing: in groups of ten in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet FDl ad libitum
- Water: drinking water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature: approximately 21°C
- Humidity: 30-70%
- Air changes: approximately 15 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: 1992-09-16 To: 1992-10-18
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction intradermal injection - 5% w/w in water (maximum practical concentration that could be prepared and dosed intradermally)
Induction topical application - 50% w/w in distilled water
Topical challenge - 50 and 25% w/w in distilled water
From preliminary investigations: 50% w/w in distilled water was the maximum practical concentration and did not give rise to irritating effects.
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- Induction intradermal injection - 5% w/w in water (maximum practical concentration that could be prepared and dosed intradermally)
Induction topical application - 50% w/w in distilled water
Topical challenge - 50 and 25% w/w in distilled water
From preliminary investigations: 50% w/w in distilled water was the maximum practical concentration and did not give rise to irritating effects.
- No. of animals per dose:
- 20 females
- Details on study design:
- A. INDUCTION EXPOSURE
- intradermal (test animals): three pairs of injections (0.1 mL each) on day 0
1st: FCA 50 : 50 with water for irrigation (Ph. Eur.)
2nd: test item, 5% w/w in water for irrigation.
3rd: test item, 5% w/w in a 50 : 50 mixture of water for irrigation and FCA
- control animals received the same treatment, except test item
- topical: following clipping, 0.2 mL per site of 10% w/w sodium lauryl sulfate was spread over the intradermal injection sites on day 6. On day 7, test item or deionized water was applied to the test item or control groups respectively.
- Exposure period, topical: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day of challenge: two weeks after the topical induction application
- Exposure period: approximately 24 hours
- Test groups: one test group
- Concentrations: 50% w/w in distilled water and applied to an anterior site on the flank, 25% w/w in distilled water applied in a similar
manner to a posterior site.
- Control group: treated as test item group
- Evaluation: approximately 24, 48 and 72 hours following patch removal - Positive control substance(s):
- yes
- Remarks:
- periodical reliability check (formalin)
Results and discussion
- Positive control results:
- The positive control caused the expected skin reactions, thus, demonstrating the sensitivity of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other:
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 72.0. Group: test group. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other:
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50% and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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