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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

Constituent 1
Chemical structure
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
IUPAC Name:
N,N-dimethylcyclohexylamine
Constituent 3
Reference substance name:
DMCHA
IUPAC Name:
DMCHA
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 levelsopen allclose all
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.
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
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:
decreased activity, ataxia, jerks, tremors, dyspnea, clonic convulsions, salivation and squinting. These signs usually lasted less than 24 hours.
Body weight:
No information provided.
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.