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EC number: 204-077-3 | CAS number: 115-27-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1978 before the development and validation of the LLNA.
Test material
- Reference substance name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- EC Number:
- 204-077-3
- EC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Cas Number:
- 115-27-5
- Molecular formula:
- C9H2Cl6O3
- IUPAC Name:
- 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
- Details on test material:
- - Name of test material (as cited in study report): Chlorendic anhydride- Analytical purity: 93.81%- Lot/batch No.: 3-12-206
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: - Age at study initiation: - Weight at study initiation: 418 to 587 g- Housing: Suspended metal cages- Diet: Purina Rabbit Chow, ad libitum and cabbage 3 times per week.- Water: ad libitum- Acclimation period: 21 daysENVIRONMENTAL CONDITIONS- Temperature (°C): - Humidity (%): - Air changes (per hr): - Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Sodium chloride solution.
- Concentration / amount:
- 0.9%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Sodium chloride solution.
- Concentration / amount:
- 0.9%
- No. of animals per dose:
- 8
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitro-1-Chlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 ml
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Wheal and flare
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 ml
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Wheal and flare
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml
- No. with + reactions:
- 5
- Total no. in group:
- 8
- Clinical observations:
- Wheal and flare
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 5.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 ml
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- Wheal and flare
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based upon the results obtained the test compound would be considered a possible sensitizing agent in man.
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