2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Reference 2

Reference Type:

other: TSCATS OTS053

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Reference substance name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

EC Number:

229-962-1

EC Name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Cas Number:

6864-37-5

Molecular formula:

C15H30N2

IUPAC Name:

4-[(4-amino-3-methylcyclohexyl)methyl]-2-methylcyclohexan-1-amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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:

other: dyspnoea, apathy, diarrhoea, poor health state, salivation, blood in stool at all dose groups reported

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