Registration Dossier
Registration Dossier
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EC number: 608-271-2 | CAS number: 28861-00-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Similar to OECD 423.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
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
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: white crystalline powder
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 210.00 +/-9.48 g (male), 208.33 +/- 6.05 g (female)
- Fasting period before study: 18 h
- Housing:
- Diet (e.g. ad libitum): LATI food
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1.5
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % methylcellulose in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 % methylcellulose
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Dose selection according to Deichmann-Le Blanck.
5 doses, 3-3 animals/dose. - Doses:
- 1000 mg/kg
2600 mg/kg
3600 mg/kg
4250 mg/kg
5000 mg/kg - No. of animals per sex per dose:
- Dose selection (approximate LD50 test)
1000 mg/kg 3 male/3 female
2600 mg/kg 3 male/3 female
3600 mg/kg 3 male/3 female
4250 mg/kg 3 male/3 female
5000 mg/kg 3 male/3 female
Test:
5000 mg/kg 6 male/6 female - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24h, 48 h, 72 h and 7. day, 14. day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, relative organ weights, histopathology
Results and discussion
- Preliminary study:
- Dose Male Female
(mg/kg) (dead/survive) (dead/survive)
1000 0/3 0/3
2600 0/3 0/3
3600 0/3 0/3
4250 0/3 0/3
5000 0/3 0/3
No sings in the doses 1000 mg/kg - 4250 mg/kg.
Slight signs in both males/females at dose 5000 mg/kg ( hair ruffling.)
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other: Hair ruffling after treatment for 2 hours.
- Gross pathology:
- Relative organ weight has not shown any deficiencies.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results acute oral toxic classification is not needed.
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