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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
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:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2910 g average weight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):
1 h, 24 h, 48h, 72 h, 96 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
15.3
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
2.6
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
2.6
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 96 h
Score:
0
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h, 96 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h, 24h,48h,72h,96h
Score:
0
Max. score:
10
Irritant / corrosive response data:
Conjuctivae effect was observed in 2 animals: congestion, edema with partly closed eyes, and discharge.
Conjuctivae symptoms were decreased in the first 24 h. Discharge was disappeared, but edema was remained.
At 72 h, 2 animals were symptom free, one still has slight congestion and edema on the eye.
At 96 h, all the 3 animals were symptom free.
No corneae and no iris change was observed.
Other effects:
Body weight gain of the test group was similar to the control group.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results the substance is slightly irritating to eyes.