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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
STABILITY
The stability of the test substance at room temperature in the vehicle DMSO and in water each over a period of 4 hours was verified analytically.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1 - 30% aqueous suspension in CMC

Doses:
200, 250, 400, 800, 1250, 1600 and 3200 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
250 mg/kg bw
Based on:
test mat.
Mortality:
All animals had died in the four highest dose groups after 14 days. For details please refer to the section 'Any other information on results incl. tables'.
Clinical signs:
3200 - 800 mg/kg:
Dyspnoea and crouched position immediately after application. After hours and on the following days some animals showed apathy, atony, red stained feces and urine, accelerated or intermittent respiration, partly chrouched position.The last animals died after 10 days.

400 - 200 mg/kg:
Immediately after the start of the experiment accelerated breathing. In the afternoon and in the follow-up time crouched position, accelerated or irregular breathing, some animals showed atony, partly reddish feces and urine and blood-encrusted snouts. The male animals of the dose 400 mg/kg were without findings after 6 days, while the females still showed crouched position until the end of the experiment. The survivors of the dose 250 and 200 mg/kg were between 4 and 12 days without findings.
Gross pathology:
Stomach hyperemia, cardiac dilation, stomach slightly dilated with fluid contents, diarrheic intestinal contents, organs stained.

Any other information on results incl. tables

Table 1: Results of the acute oral toxicity test in rats with the test substance

Dosis [mg/kg]

Conc. [%]

No. of animals

Dead animals

1 hour

24 hours

48 hours

7 days

14 days

3200

30

5 m

5 f

0/5

0/5

5/5

4/5

5/5

4/5

5/5

4/5

5/5

5/5

1600

16

5 m

5 f

0/5

0/5

3/5

4/5

3/5

4/5

5/5

5/5

 

1250

10

5 m

5 f

0/5

0/5

3/5

4/5

4/5

4/5

5/5

4/5

5/5

5/5

800

8

5 m

5 f

0/5

0/5

0/5

1/5

0/5

1/5

4/5

3/5

5/5

5/5

400

4

5 m

5 f

0/5

0/5

2/5

0/5

3/5

2/5

3/5

3/5

3/5

5/5

250

4

5 m

5 f

0/5

0/5

1/5

0/5

1/5

0/5

2/5

1/5

2/5

2/5

200

2

5 m

5 f

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

 

m: males

f: females

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Under the conditions of this test, an acute oral toxicity LD50 of 250 mg/kg was determined for the test item in rats.
Executive summary:

In an acute oral toxicity study equivalent to OECD guideline 401, male and femal rats were orally administered with a 0.1 - 30% aqueous suspension of the test substance in CMC. Five animals per sex received the test substance at doses of 200, 250, 400, 800, 1250, 1600 and 3200 mg/kg and were observed for 14 days. All animals had died in the four highest dose groups after 14 days.
In the dose groups 800 to 3200 dyspnoea and crouched position was observed immediately after application. After hours and on the following days some animals showed apathy, atony, red stained feces and urine, accelerated or intermittent respiration, partly chrouched position.The last animals died after 10 days.
The animals of the dose groups 400 to 200 mg/kg showed immediately after the start of the experiment accelerated breathing. In the afternoon and in the follow-up time crouched position, accelerated or irregular breathing, some animals showed atony, partly reddish feces and urine and blood-encrusted snouts. The male animals of the dose 400 mg/kg were without findings after 6 days, while the females still showed crouched position until the end of the experiment. The survivors of the dose 250 and 200 mg/kg were between 4 and 12 days without findings.
Based on these results, an LD50 of 250 mg/kg (m/f) was determined for rats.