Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
minor deviations e.g. dose level
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
2000 mg/kg/b.w.
200 mg/kg/b.w.
No. of animals per sex per dose:
3 females 2000 mg/kg/b.w.
3 females 200 mg/kg/b.w.
3 males 200 mg/kg/b.w.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 value for male and female rats is greater than 200 mg/kg and was not exactly determined.

Any other information on results incl. tables

Animals employed as well as mortality

dose (mg/kg b.w)       sex       number of animals*       time of deaths       mortality %

200                            m            0/3                                                         0

200                            f             0/3                                                         0

2000                          f              2/3                            3 hours                  67   

* number of animals dying/number of animals employed

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value for male and female rats is greater than 200 mg/kg and was not exactly determined.
Based on the investigations, the test substance has to be regarded as harmful if swallowed.
Executive summary:

Toxicological investigations in male and female rats were conducted after single oral administration of 4,6 -dichloropyrimidine. The LD50 was greater than 200 mg for the male and female rats.

After administration of 2000 mg/kg body weight the following clinical signs were observed in female rats: dazed condition and apathy. Two of three animals died.

After a single doese of 200 mg/kg no signs were observed in male rats, females showed piloerection up to 8 hours after application.

Body weight development was not significantly affected in both sexes after 200 mg/kg.

At necroscopy of the two intercurrent deaths females (2000 mg/kg) showed the following gross pathological findings: strong reddening of the muscosa in stomach and small intestine, liver mottled.

None of the animals sacrified at the end of study showed any noticeable gross pathological findings.