Cyclohexyldimethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Provides basic data; some details missing including dose levels.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was administered to groups of male and female Sprague Dawley rats by oral gavage and observed for a period of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexyldimethylamine

EC Number:

202-715-5

EC Name:

Cyclohexyldimethylamine

Cas Number:

98-94-2

Molecular formula:

C8H17N

IUPAC Name:

N,N-dimethylcyclohexanamine

Constituent 2

Reference substance name:

N,N-dimethylcyclohexylamine

Cas Number:

98-94-2

IUPAC Name:

N,N-dimethylcyclohexylamine

Constituent 3

Reference substance name:

N,N-dimethylcyclohexanamine

Cas Number:

98-94-2

IUPAC Name:

N,N-dimethylcyclohexanamine

Details on test material:

Polycat 8
CAS 98-94-2 (cyclohexyldimethylamine), N,N-dimethylcyclohexylamine (DMCHA)
purity not indicated
Lot # 79-507-CJ
Liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age: no data
- Weight at study initiation: 110 g
- Housing: During the observation period the rats were housed in stainless steel hanging cages with up to two rats of the same sex and dosage group per cage.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.63ml/kg.

Doses:

Dosages ranged from 0.25 to 0.63ml/kg.

No. of animals per sex per dose:

10/sex/dose

Control animals:

no

Details on study design:

ADMINISTRATION: 
- Doses: 0.25-0.63 ml/kg
- Doses per time period: single 
- Post dose observation period: 14-days

EXAMINATIONS:
mortality/clinical signs
limited necropsy on all animals that died and on up to 3/sex/treatment of the survivors

Statistics:

No information provided

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 272 - < 289 mg/kg bw

Remarks on result:

other: Originally reported in ml/kg; mg/kg bw  determined using a density of 0.849 g/cm3.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

289 mg/kg bw

95% CL:

> 221 - < 340

Remarks on result:

other: originally reported as 0.34 ml/kg bw, 95% confidence interval 0.26-0.40

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

272 mg/kg bw

95% CL:

> 238 - < 306

Remarks on result:

other: Originally reported as 0.32 ml/kg, 95% confidence interval 0.28-0.36

Mortality:

- Number of deaths at each dose: not specified
- Time of death: within 24 hours, and a few delayed deaths

Clinical signs:

other: decreased activity, ataxia, jerks, tremors, dyspnea, clonic convulsions, salivation and squinting. These signs usually lasted less than 24 hours.

Gross pathology:

(a) in the majority of animals that died: gastric lesions, suggestive of irritation, were observed, including red linear mucosal streaks or red discoloration of mucosa. An occasional erosion and one example of mucosal oedema was also observed.
(b) in some animals that survived: thin connective tissue adhesions in stomach serosa and varios adnexal structures were found in some animals. Mucosal keratinization of stomach was found in one animal.

Other findings:

No additional information provided

Any other information on results incl. tables

Gross examination of animals dying acutely or survivors at the end of the 14 day observation period, suggested that Polycat 8 was irritating to the stomach under the conditions of this study.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of this study, the LD50 of the test substance was found to be between 272 and 289mg/kg bw. Based on this result, the test substance was considered to be a Category 3 toxicant and should have the signal word Danger and the hazard statement, H301: Toxic if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful and have the risk phrase R22: Harmful if swallowed associated with it.

Executive summary:

In a study conducted in 1979, the test substance, cyclohexyldimethylamine (DMCHA) was evaluated for its ability to induce toxicity when administered to male and female Sprague Dawley rats via oral gavage. The concentration administered ranged from 0.25 to 0.63 ml/kg. Following a single administration, the animals were observed for a 14 day post-exposure period.

Rats treated with DMCHA exhibited decreased activity, ataxia, jerks, tremors, dyspnea, clonic convulsions, salivation and squinting. These signs usually lasted less than 24 hours. Most deaths occurred within 24 hours after treatment although a few delayed deaths also occurred.

Gross examination of animals dying acutely and survivors at the end of the 14-day recovery period suggested that DMCHA, administered under the conditions of this study, was irritating to the stomach.

Under the conditions of this study, the LD₅₀ of the test substance was found to be between 272 and 289mg/kg bw. Based on this result, the test substance was considered to be a Category 3 toxicant and should have the signal word Danger and the hazard statement, H301: Toxic if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful and have the risk phrase R22: Harmful if swallowed associated with it.