L-Tyrosine, N-(aminocarbonyl)-3-methoxy-O,.alpha.-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1990

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Principles of method if other than guideline:

Animal hoosekeeping, and hair removing is different from guideline method.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 243.33 +/- 6.83 (male); 207.5 +/-5.24 (female)
- Acclimation period: 24 hour before treatment the hair was removed from 20 % of the body surface.

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 20% of body surface
- % coverage:
- Type of wrap if used: gauze and aluminium foil and adhesive plaster.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): pure substance
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 male / 6 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 1, 2, 3, 7, 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, relative organ weights, histopathology.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality.

Clinical signs:

other: No signs.

Gross pathology:

No difference observed between the control and tested animals.

Other findings:

Female rats body weight gain was very slow, but other signs was not observed.
Hair growing on the treated area was normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance did not absorbed through skin.
Not classified as acute dermal toxic substance.