Registration Dossier
Registration Dossier
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EC number: 928-472-1 | CAS number: 1184301-52-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.05.2004 - 02.12.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Old study
Test material
- Reference substance name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- EC Number:
- 928-472-1
- Cas Number:
- 1184301-52-7
- Molecular formula:
- C11-H17-N3-O6-S x 3H2O
- IUPAC Name:
- (6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- In the study report is mentioned that a dihydrate was used for testing, this statement is not correct. After further evaluation of the substances it was found out that it is a trihydrate. The batch for testing was a typical production batch.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Dunkin Hartley Guinea pigs were obtained from LAB-ALL Bt. Budapest
- The weight variation in animals involved in the study was not exceed +/- 20% of the mean weight.
- Acclimatization time is 28 days.
CONDITIONS
- The animals received tap water, ad libitum containing 50mg/100mL Ascorbic Acid
- Animals received PURISTAR standard diet for rabbits produced by AGRIBRANDS Europe
- The animal rooms were designed to permit 8-12 air exchange/hour by central air-condition system.The target temperature and relative humidity ranges were 20 +/- 3°C and 30-70%, respectively
- Light cycle is 12 hours daily from 6 am to 6 pm (artificial light)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1% homogenized methyl cellulose
- Concentration / amount:
- 0.1 ml (1% test item)
- Day(s)/duration:
- Day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5 ml of the test item, concentration 75%
- Day(s)/duration:
- day 8, 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5 ml of the test item, concentration 75%
- Day(s)/duration:
- day 22, 24h
- No. of animals per dose:
- 10 animals
5 Controls - Details on study design:
- Only animals in acceptable health condition were used for the test as certified by the veterinarian.
The dermal irritation scores (in the case of the preliminary study (primary irritation) and in case of induction dermal exposures) were evaluated according to the scoring system by Draize. - Challenge controls:
- dermal application of the test item
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- On the basis of the results of the present study, the test item SND 199 Precursor 3a ((-)-SND 855 Tartrate) was classified as no sensitizer.
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