Registration Dossier
Registration Dossier
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EC number: 609-521-3 | CAS number: 38109-77-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- ethyl 3-amino-2-cyanoprop-2-enoate
- Cas Number:
- 38109-77-2
- Molecular formula:
- C6H8N2O2
- IUPAC Name:
- ethyl 3-amino-2-cyanoprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Ethoxamide
- Physical state: white or almost white crystalline powder
- Lot/batch No.: 29
- Expiration date of the lot/batch: 05. 2002
- 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: 327-381 g
- Housing: Macrolon cage, size III (42x42x19 cm), 2-3 animals / cage
- Bedding: Laboratory bedding
- 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 ml Ascorbic acid
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 13-17
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 0.1 (w/v) % (in physiological saline and Freund's complete adjuvant ) and
25, 50, 75 (w/v) % (test item in methyl cellulose (1%) for preliminarydose range finding study)
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:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 0.1 (w/v) % (in physiological saline and Freund's complete adjuvant ) and
25, 50, 75 (w/v) % (test item in methyl cellulose (1%) for preliminarydose range finding study)
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:
- 2 animals / 2 concentration in preliminary dose range finding study
10 pcs (in test groups)
5 pcs (in control groups) - Details on study design:
- see under paragraph 'any other information...'
- Challenge controls:
- The challenge was performed as a dermal exposure (Closed Patch Test).
Left shaved flank areas of the animals (both the test and the control) were treated with 0.50 ml of the test item ( in concentration 75 %). The right shaved flank areas were treated with 0.50 ml of methyl cellulose (1 %) in all cases. Time of exposure was 24 hours. - Positive control substance(s):
- yes
- Remarks:
- potassium dichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- 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: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. 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:
- 10
- Clinical observations:
- no visible change
- 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: 10.0. Clinical observations: no visible change.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- 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: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Challenge with test item evoked no positive responses in the test animals sentitized previously. At the same time, none of the animals proved to be sensitive in the control group. The net response value represented an incidence rate of 0 % and the net score value of 0.00.
On the basis of the resulst of the present study, the test item Etoxamid was classified as no sensitizer.
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