Registration Dossier
Registration Dossier
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EC number: 614-070-0 | CAS number: 674773-12-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Cas Number:
- 674773-12-7
- Molecular formula:
- C10H10N2O4S
- IUPAC Name:
- methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Thiofaminomet
- Physical state: greenish yellow powder
- Lot/batch No.: 45
- Expiration date of the lot/batch: 09 2004
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt , Hunyadi 7, Budapest, H-1174, Hungary
- Weight at study initiation: 276-315 g
- Housing: Macrolon cage, size III (42x42x19 cm), 2-3 animals / cage
- Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasem
- Diet (e.g. ad libitum): ad libitum (PURISTAR standard diet for rabbits produced by AGRIBANDS Europe Hungary)
- Water (e.g. ad libitum): ad libitum, tap water for human consumption containing 50 mg / 100 mlAscorbic acid
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Methyl cellulose (1 %)
- Concentration / amount:
- 75 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment)
0.1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Methyl cellulose (1 %)
- Concentration / amount:
- 75 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment)
0.1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment)
- No. of animals per dose:
- 10 pcs (in test groups)
5 pcs (in control groups) - Details on study design:
- TREATMENTS
Intraermal Induction Exposure Dermal Induction Exposure Challenge Exposure
(Main study I) (Main study II)
Dose group Control group Test group Control group Test group Control group Test group
Number of animals 5 10 5 10 5 10
Concentration of the test item - 0.1 % - 75 % 75 % 75 %
Day of the treatment 1 1 8 8 22 22
Time of exposure (h) 24 24 48 48 24 24
Day of the treatment
with 10% sodium lauryl - - 7 7 - -
sulphate in vaseline
Time of observation 24 hours 24 hours 1, 24, 48 and 72 hours 24 and 48 hours
after the after the after the patch removal after the patch removal
treatment treatment
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: no signs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the results of the present study, the test item was classified as no sentitizer.
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