Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure observation period 7 days)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight at initiation: 180-208g (males), 144-170g (females)
No further details.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous suspension with 0.5% carboxymethylcellulose
Details on oral exposure:
concentration in test solution 35%; application volume 28.5 or 13.3 ml/kg bw, respectively; no data about fasting prior to application.

Doses:
4640 or 10000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations:daily
- weighing: day 0, 2, or 7
- Necropsy of survivors and rats found dead
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 000 mg/kg bw
Remarks on result:
other: for males and females combined
Mortality:
Data on mortality are presented in the Table below. At the high dose levels rats died within 4 h as well as one female at the low dose level. Females more susceptible than males.
Clinical signs:
Clinical signs in both dose groups: immediately after gavage prone and side position, apathy, atony, gasping, cyanosis; 2nd day red encrusted noses; symptoms still present after 2 days. No symptoms detected 5 days after application.
Body weight:
No effects on body weight gain.
Gross pathology:
Surviving rats: darkened liver and some cases of splenomegaly.
Rats found dead: dilatation of the heart; hyperemia
Other findings:
no data

Any other information on results incl. tables

Mortality in male and female rats after gavage; observation period 7 days

 Dose in mg/kg bw  Males  Females
 4640  0/5  1/5
 10000  3/5  4/5

Applicant's summary and conclusion

Conclusions:
The oral LD50 is 8000 mg/kg bw in male and female rats combined.
Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; post exposure observation period 7 days)

Groups of 5 male and 5 female rats were gavaged with 35% aqueous suspension at dose levels of 4640 and 10000 mg/kg bw. The post exposure observation period was 7 days. Clinical signs occurred immediately after gavage: prone and side position, apathy, atony, gasping, cyanosis, and 2nd day red encrusted noses; symptoms were still present after 2 days. No symptoms were detected 5 days after application.. Generally, females were more susceptible than males. The body weight gain was not reduced. Necropsy revealed dilatated heart and some cases of splenomegaly.

Conclusion: The oral LD50 is 8000 mg/kg bw in male and female rats combined.