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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 July 1978 - 26 July 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
other: TSCATS OTS053
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
The study documentation does not state whether the animals were fed or fasted, as it is often the case in pre-guideline studies. However, the described toxicity fits well into the overall toxicity profile of the test substance.
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre GLP-study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 188 g (mean), females: 165 g (mean)



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 3.16, 4.64, 6.81, 10.0 %

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:
316, 464, 681, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of exposure and daily thereafter
- Frequency of weighing: days 0, 2, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 320 - < 460 mg/kg bw
Mortality:
316 mg/kg bw: no mortality occurred;
464 mg/kg bw: 4 males and 3 females died within 24 h;
681 mg/kg bw: 5 males and 4 females died within 24 h;
1000 mg/kg bw: 5 males and 3 females died within 24 h, all animals died within 48 h.
Clinical signs:
dyspnoea, apathy, diarrhoea, poor health state, salivation, blood in stool at all dose groups reported
Body weight:
The surviving animals gained weight (only mean values given)
Gross pathology:
Gross pathology revealed reddening in stomach and gut, scattered occurrence of gastric ulcer, and diarrheic gut contents, acute dilatation of heart in animals that died. No changes were noted in organs of sacrificed animals.

Any other information on results incl. tables

Table 1: Mortality:

 Dose

(mg/kg bw)

 Gender

 Conc. %

 1 h

 24 h

 48 h

 day 7

 day 14

1000

 male

10

0/5

5/5

5/5

5/5

5/5

1000

 female

10

0/5

3/5

5/5

5/5

5/5

681

 male

6.81

0/5

5/5

5/5

5/5

5/5

681

 female

6.81

0/5

4/5

4/5

4/5

4/5

464

 male

4.64

0/5

4/5

4/5

4/5

4/5

464

 female

4.64

0/5

3/5

3/5

3/5

3/5

316

 male

3.16

0/5

0/5

0/5

0/5

0/5

316

female 

3.16

0/5

0/5

0/5

0/5

0/5 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria