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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in accordance with generally accepted scientific principles; however full data on methodology is not given and no information relating to GLP status is provided. An accurate assessment of the study is therefore not considered to be possible.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rabbits were exposed to the test material for 24 hours in an occlusive fashion at a single dose level, with two animals per dose.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,6-Dichloro-2-ethoxypyrimidine
EC Number:
805-107-3
Cas Number:
40758-65-4
Molecular formula:
C6H6Cl2N2O
IUPAC Name:
4,6-Dichloro-2-ethoxypyrimidine
Test material form:
other: aqueous solution
Details on test material:
- Physical state: liquid (20% aqueous solution)

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ~3.8 kg

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: The test material was applied to the clipped back.
- Type of wrap if used: The test material was held in contact with the skin with a porous gauze dressing. A plastic wrap was then placed around the gauze and trunk of the rabbit and secured with non-irritating tape. The plastic wrap was covered with flannel bandages and held in place with non-irritating tape.

TEST MATERIAL
- Concentration (if solution): 20 % solution in water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg )of a 20% aqueous solution)
No. of animals per sex per dose:
2 males
Control animals:
no

Results and discussion

Mortality:
One animal was euthanised on the day of dosing. The remaining animal was found dead on day 2.
Clinical signs:
Within 1 hour after dosing, one rabbit was observed with mouth breathing, convulsions, rolled eyes, bleeding through nose and laboured respiration. The animal was euthanised because of severe convulsions.
The remaining rabbit was observed with mouth breathing, convulsions, laboured respiration and tremors on day one, and was found dead on day 2.

Applicant's summary and conclusion

Interpretation of results:
other: it is not possible to assign a classification with available data
Conclusions:
The report does not include an LD50 value; however both animals dosed at 2000 mg/kg as a 20 % aqueous solution died. At least Category 3 classification under CLP is required, based on a calculated LD50 in terms of neat substance of <400 mg/kg.
Executive summary:

The acute toxicity potential of the test material was investigated via the dermal route.

Two male rabbits received a single dermal application of 2000 mg/kg which was administered as a 20 % solution in water. The test material was applied to the clipped back and held in contact with the skin in an occlusive fashion.

Within 1 hour after dosing, one rabbit was observed with mouth breathing, convulsions, rolled eyes, bleeding through nose and laboured respiration. The animal was euthanised because of severe convulsions. The remaining rabbit was observed with mouth breathing, convulsions, laboured respiration and tremors on day one, and was found dead on day 2.

The report does not include an LD50 value but this can be calculated at <400 mg/kg based on neat substance.