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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register 38, No. 187, § 1500.42 (eye), p. 27019, September 27, 1973 (Draize test)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6-amino-5-formamido-1,3-dimethyluracil
EC Number:
231-501-4
EC Name:
6-amino-5-formamido-1,3-dimethyluracil
Cas Number:
7597-60-6
Molecular formula:
C7H10N4O3
IUPAC Name:
N-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide
Details on test material:
- Name of test material (as cited in study report): 1,3-dimethyl-4-amino-5-formylaminouracil
- Substance No. 80/205
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler GmbH, Offenbach
- Weight at study initiation: mean 2.85 kg (males), 2.88 kg (females)
- Housing: sngle hoausing in stainless steel wire mesh cages (floor area 40 x 51 cm)
- Diet (e.g. ad libitum): OVATOR SOLIKANIN 4 MM ; Mukator-Werke, Duesseldorf (ca. 130 g daily/animal)
- Water (e.g. ad libitum): VE-water (weekdays), tap water (weekends); ca. 25 ml daily/animal
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated other eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (ca. 31 mg)
Duration of treatment / exposure:
one application, no removal
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
acc.. to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
3
Reversibility:
not fully reversible within: 72 h in 1/6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritant / corrosive response data:
At the 24-h reading 2/6 animals showed slight reddening of the conjunctivae and at the 48-h reading 3/6 animals showed very slight reddening of the conjunctivae. This finding was still seen in one animal at the 72-h reading and another animal showed slight opacity of the corney on an area of about < 25%.

Any other information on results incl. tables

Results:

Animal 1: female, 2.62 kg

Animal 2: female, 2.85 kg

Animal 3: female, 2.95 kg

Animal 4: male, 2.76 kg

Animal 5: male, 2.94 kg

Animal 6: male, 3.10 kg

Scoring:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
24 h 1 0 0 0 0 0 0  
2 0 0 0 1 0 0  
3 0 0 0 0 0 0  
4 0 0 0 0 0 0  
5 0 0 0 0 0 0  
6 0 0 0 1 0 0  
48 h 1 0 0 0 0 0 0  
2 0 0 0 1 0 0  
3 0 0 0 0 0 0  
4 0 0 0 1 0 0  
5 0 0 0 1 0 0  
6 0 0 0 0 0 0  
72 h 1 0 0 0 0 0 0  
2 0 0 0 0 0 0  
3 0 0 0 0 0 0  
4 0 0 0 0 0 0  
5 0 0 0 1 0 0  
6 0 0 0 0 0 0  
mean 24 - 72 h 1 0.0 0.0 0.0 0.0 0.0 0.0  
2 0.0 0.0 0.0 0.7 0.0 0.0
3 0.0 0.0 0.0 0.0 0.0 0.0
4 0.0 0.0 0.0 0.3 0.0 0.0
5 0.0 0.0 0.0 0.7 0.0 0.0
6 0.0 0.0 0.0 0.3 0.0 0.0
mean   0.0 0.0 0.0 0.4 0.0 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU