1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-06-12 to 1985-07-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine

EC Number:

259-393-4

EC Name:

1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine

Cas Number:

54914-37-3

Molecular formula:

C18H34N2

IUPAC Name:

1,3,3-Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethanamine

Test material form:

other: liquid

Details on test material:

Produced October 1980. Purity 95 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

3160; 3980; 5010; 6310 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 150 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 517 - <= 4 897

Mortality:

- Number of deaths at each dose:
  3160 mg/kg bw: 0 males, 2 females dead within 26 hours
  3980 mg/kg bw: 1 male, 4 females dead within 24 hours
  5010 mg/kg bw: 2 males, 3 females dead within 48 hours
  6310 mg/kg bw: 5 males, 4 females dead within 30 hours

Clinical signs:

other: - 30 minutes after application: Ruffled fur - later: Crouched posture, some cases of slight sedation and ataxia,  staggering gait, prone position, cyanosis of the extremities,  hypothermia, and narrowed or closed palpebral fissures - at 24 hours (additi

Gross pathology:

- animals that died during the study: Swelling of the gastric mucosa,  hyperemia of the gastric and intestinal mucosa, the peritoneum and the  diaphragm, and of the pancreas; formation of flecks on liver and kidneys
- terminal necropsy: Areas of whitish fur on the cardial mucosa,  discoloration of the liver, conglutination and fusion of the abdominal  organs with one another and with the diaphragm

Applicant's summary and conclusion

Conclusions:

The LD50 value (oral) of 1,3,3 -Trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine in female and male rats was estimated to be 4150 mg/kg bw. Therefore, under the conditions employed in this study, the acute toxicity after oral exposure in rats is low.

Executive summary:

1,3,3 -Trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine is of low oral acute toxicity with an oral LD₅₀(rat) of 4150 mg/kg bw (OECD 401, Hüls AG, 1985). Mortalities were observed in the oral acute toxicity study at doses > 3160 mg/kg bw. Clinical signs after oral administration like ruffled fur 30 min after application, later: crouched posture, some cases of slight sedation and ataxia, staggering gait, prone position, cyanosis of the extremities, hypothermia, and narrowed or closed palpebral fissures. At 24 h additional observations, like diarrhea and increased diuresis were made. In the two highest dose groups (i.e. 5010 and 6310 mg/kg bw respectively), difficulties with breathing, uttering sounds when touched and towards the end of the study ruffled fur in 2 animals from the high dose group were observed. Other signs disappeared approximately by day 10.