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EC number: 414-780-9 | CAS number: 38585-74-9 A-87440.0; A-87440.00
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:
- May 11 1994 to Oct 06 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EEC Part B
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 5-thiazolylmethanol
- EC Number:
- 414-780-9
- EC Name:
- 5-thiazolylmethanol
- Cas Number:
- 38585-74-9
- Molecular formula:
- C4H5NOS
- IUPAC Name:
- (1,3-thiazol-5-yl)methanol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc, Michigan
- Age at study initiation: ~ 1 month
- Weight at study initiation: 250 - 350gram
- Housing: Individual Stainless Steel ventilated cages
- Diet: Certified Guinea Pig Chow®
- Water: ad libitum
- Acclimation period: 5 days followed by an 8 day pretreatment period.
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67 - 72
- Humidity (%): Ambient
- Photoperiod (hrs dark / hrs light): 12hr daily light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection) and Second Induction (topical application): 100%
Concentration of test material used for challenge:
a) 25% in corn oil
b) 100%
Challengeopen allclose all
- Route:
- other: topical
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material at First Induction (Intradermal injection) and Second Induction (topical application): 100%
Concentration of test material used for challenge:
a) 25% in corn oil
b) 100%
- No. of animals per dose:
- 10 animals assigned to the negative control group.
20 animals assigned to treatment group. - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and topical
- Exposure period: 7 days for first induction and 14 days for second induction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24hr occlusive bandage
- Test groups:
- Site:left flank - 25% test substance in corn oil; right flank - 100% test substance
- Evaluation (hr after challenge):24 and 48 hr after treatment- local reaction (erythema, edema)
Body weights were measured twice during the pretreatment period and on the days of the first and second inductions and the challenge and on the day of the final observation period. - Challenge controls:
- 10 animals with water for 1st and 2nd induction. Challenge: a) 25% in corn oil and b) 100%
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Sensitivity of the guinea pig strain periodically checked in Abbott Laboratories with 1-chloro-2,4-dinitrobenzene
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance does not induce delayed contact hypersensitivity in guinea pigs in this study.
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