Registration Dossier
Registration Dossier
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EC number: 414-490-2 | CAS number: 154212-59-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August-September 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:
- 84/449/EEC Part B
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 414-490-2
- EC Name:
- -
- Cas Number:
- 154212-59-6
- Molecular formula:
- C11H9ClN2O5S
- IUPAC Name:
- 4-nitrophenyl (1,3-thiazol-5-yl)methyl carbonate hydrochloride
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, Portage, 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 a 7 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:
- petrolatum
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injection - 2% in 0.2% hydroxypropylmethyl
cellulose
b) Topical application - 50% w/w in petrolatum
Concentration of test material and vehicle used for each challenge:
a) Topically: 25% w/w in petrolatum
b) Topically: 50% w/w in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injection - 2% in 0.2% hydroxypropylmethyl
cellulose
b) Topical application - 50% w/w in petrolatum
Concentration of test material and vehicle used for each challenge:
a) Topically: 25% w/w in petrolatum
b) Topically: 50% w/w in petrolatum
- 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 7 days for second induction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 14
- Exposure period: 24hr occlusive bandage
- Test groups:
- Site:left flank - 25% test substance in petrolatum; right flank - 50% test substance in petrolatum
- Evaluation (hrs after challenge): 24 and 48 hr after treatment- local reaction (erythema, edema)
Body weights measured twice during the pretreatment period, on the day of the first and second inductions and challenge and on the final day of observations. - 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:
- n/a: 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:
- other:
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% and 50% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% and 50% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% and 50% in petrolatum
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- Mild to moderate erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 50% in petrolatum. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: Mild to moderate erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction:
All animals showed signs of irritation following intradermal
and topical induction.
Evidence of sensitisation of each challenge concentration:
17/20 test animals receiving 25% in petrolatum
17/20 test animals receiving 50% in petrolatum.
Other observations:
There were no skin reactions amongst the 10 control animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance induced delayed contact hypersensitivity in guinea pigs in this study.
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