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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions (pre-GLP study). 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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
Details on test material:
- Name of test material (as cited in study report): Laromin C 260 liquid (3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane)

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
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:
No specific clinical symptoms were noted apart from occasional salivation and blood in stool.
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 in animals that died. No changes were noted in organs of sacrificed animals.

Any other information on results incl. tables

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