4,6-Dichloro-2-ethoxypyrimidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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:

The test material was administered as a single dose via gavage to male Fischer 344 rats at three dose levels, three animals per dose. Surviving animals were observed for two weeks post-exposure.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The 2000 mg/kg dose was delivered neat; the 50 and 500 mg/kg doses were administered as a 5 or 10 % solution in water, respectively.

Doses:

50, 500 and 2000 mg/kg

No. of animals per sex per dose:

3 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and bodyweights were recorded. Bodyweight data was reported on days 1, 2, 8 and 15

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 50 - < 500 mg/kg bw

Based on:

test mat.

Mortality:

All rats which received 2000 mg/kg died on day 1.
Of the rats that received 500 mg/kg, one died on day 1, a second died on day 2 and the remaining rat survived the two week observation period.
All three rats which received 50 mg/kg survived until the end of the observation period.

Clinical signs:

Clinical signs for animals given 2000 mg/kg consisted of salivation, lacrimation, urine and faecal perineal soiling, laboured respiration, loose stools and laterally recumbent.
Clinical signs noted for animals given 500 mg/kg consisted of salivation, lacrimation, faecal perineal soiling, decreased activity, incoordination and laterally recumbent.
Animals given 50 mg/kg had no adverse clinical signs.

Body weight:

The surviving rats gained weight during the study.

Any other information on results incl. tables

Table 1 Summary of Bodyweight Data (g)

Dose Group (mg/kg)	Animal Number	Test Day
		1	2	8	15
2000	94A3145	201.2	-	-	-
	94A3146	178.9	-	-	-
	94A3147	190.4	-	-	-
500	94A3601	190.0	-	-	-
	94A3602	174.5	-	-	-
	94A3603	180.3	165.9	176.5	211.2
50	94A3151	177.4	199.1	207.0	218.2
	94A3152	176.4	197.8	210.0	223.1
	94A3153	171.6	190.9	202.9	210.7

- = animal dead

Applicant's summary and conclusion

Interpretation of results:

other: Category 3

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for male Fischer 344 rats was between 50 and 500 mg/kg. It is therefore considered that the test material requires classification as Category 3 for acute oral toxicity in accordance with EU criteria.

Executive summary:

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

Three fasted male Fischer 344 rats received 50, 500 or 2000 mg/kg of test material by single dose oral gavage. The 2000 mg/kg dose was delivered neat while the 50 and 500 mg/kg doses were administered as a 5 or 10 % solution in water, respectively. The animals were then observed for two weeks post-exposure.

All rats receiving 2000 mg/kg and one rat receiving 500 mg/kg died on day 1. One rat dosed with 500 mg/kg died on day 2. The rats which received 50 mg/kg and one rat dosed with 500 mg/kg survived the two week study period.

Clinical signs for animals given 2000 mg/kg consisted of salivation, lacrimation, urine and faecal perineal soiling, laboured respiration, loose stools and laterally recumbent. Clinical signs noted for animals given 500 mg/kg consisted of salivation, lacrimation, faecal perineal soiling, decreased activity, incoordination and laterally recumbent. Animals given 50 mg/kg had no adverse clinical signs. The surviving rats gained weight during the study.

The acute oral LD50 for male Fischer 344 rats was between 50 and 500 mg/kg. It is therefore considered that the test material requires classification as Category 3 for acute oral toxicity in accordance with EU criteria.