2,6-dimethylcyclohexylamine

Acute Toxicity: oral

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. details on test substance or pH value of tested solution).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dimethylcyclohexylamine

EC Number:

229-942-2

EC Name:

2,6-dimethylcyclohexylamine

Cas Number:

6850-63-1

Molecular formula:

C8H17N

IUPAC Name:

2,6-dimethylcyclohexan-1-amine

Details on test material:

stable for 2 years; no further details

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Dr. Thomae, Biberach, Germany
Acclimatisation period:1 week
Age: 12 weeks; weight: +-20% of average weight
5 rats per cage
certified food and tap water ad libitum
food withheld 16 h prior to gavage
relative air humidity 30-70%, temperature 20-24°C, dark-light-cycle: 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other:

Details on oral exposure:

The test substance was solved in aqeous solution of 0.5% carboxymethyl-cellulose (emulsion)

Doses:

121, 178, 215, 261 mg/kg bw; concentrations: 1.21, 1.78, 2.15, 2.61% (w/v).
Treatment of 5 males and 5 females with a dose of 215 mg/kg bw was performed 3 months later.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Application volume: 10 ml/kg bw
- Duration of observation period following administration: 14 days
- Frequency of observations: serveral times on the day of application, at least once daily thereafter
- Weighing: day 0, 2, 3, 7, 13
- Necropsy of survivors and rats found dead performed: yes
- Other examinations performed: clinical signs

Statistics:

no data

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 215 - < 261 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

226 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 215 - < 261 mg/kg bw

Mortality:

Males: all animals in the high dose group died within 24 h, all other rats survived.
Females: 1/5 rats died at 215 mg/kg bw and all rats at the high dose level. Rats died within the 1st 24 h.

Clinical signs:

other: First symptoms occurred 30 minutes after gavage of 261 and 215 mg/kg bw; in survivors the syptoms lasted 4 h; authors described dyspnoea, apathy, staggered gait, atony, side position, twitching and poor general condition. In female rats symptoms (dyspnoea

Gross pathology:

No treatment related effects were detected in survivors and general congestive hyperemia in rats found dead.

Other findings:

no

Any other information on results incl. tables

Comment: alkalinity of test solution not measured; systemic effects not excluded.

Applicant's summary and conclusion

Conclusions:

In male and female rats combined the LD50 after gavage was >215 and < 261 mg/kg bw

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. details on test substance or pH value of tested solution).

Male and female rats received via gavage the test substance at 4 dose levels (n=5 per dose per sex); the post exposure observation period was 14 days. The test substance resulted in the following clinical signs: dyspnoea, apathy, staggered gait, atony, side position, twitching and poor general condition; survivors appeared normal 4 h after gavage. The LD50 was > 215 and <261 mg/kg bw for both sexes combined.

Conclusion: In male and female rats the oral LD50 was >215 and < 261 mg/kg bw.