Registration Dossier
Registration Dossier
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EC number: 608-271-2 | CAS number: 28861-00-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990-1991
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The animal test was not followed an appropriate guideline. The test was not performed by a recommended method. The applied test material concentration was not followed the recommendations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Principles of method if other than guideline:
- Test was carried out according to Maguire method, evaluation was carried out according to Kligman recommendations.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- EC Number:
- 608-271-2
- Cas Number:
- 28861-00-9
- Molecular formula:
- C13H18N2O5
- IUPAC Name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- Details on test material:
- Name of test material (as cited in study report): Ureido-karbonsav
- Substance type: organic
- Physical state: white crystalline powder
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 513.33 +/- 51. 6 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12h
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 9 days
- Test groups: 10 animals
- Control group: 10 animals
- Site: 1st
- Frequency of applications: 1st day, 2nd day, 4th day Freud adjuvant and exposure, 7th day
- Duration: 9 days
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 16th day
- Exposure period: 1 day
- Test groups: 10 animals
- Control group: 10 animals
- Site: 2nd
- Concentrations: 0.2ml, 10 times diluted
- Evaluation (hr after challenge): 24h, 48 h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 17th day
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- slight erythema with slight swelling
- Remarks on result:
- other: Reading: other: 17th day. . Hours after challenge: 24.0. Group: test group. Dose level: concentrated. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: slight erythema with slight swelling.
- Reading:
- other: 17th day
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % diluted
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- slight erythema with slight swelling
- Remarks on result:
- other: Reading: other: 17th day. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % diluted. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: slight erythema with slight swelling.
- Reading:
- other: 18th day
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- slight erythema with slight swelling
- Remarks on result:
- other: Reading: other: 18th day. . Hours after challenge: 48.0. Group: test group. Dose level: concentrated. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: slight erythema with slight swelling.
- Reading:
- other: 18th day
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % diluted
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- slight erythema with slight swelling
- Remarks on result:
- other: Reading: other: 18th day. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % diluted. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: slight erythema with slight swelling.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is moderate skin sensitiser according to this test result.
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