2,6-dimethylcyclohexylamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 403

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation 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:

Stability: 2 years
Purity: > 99%
Isomer: 58 % all-trans form, 14 % all-cis form, 28 % mixed form

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Dr. Thomae, Biberach, Germany
At initiation the age was 8 weeks and weight of males 263 +- 50 g, and females 178 +- 38 g
5 rats per cage
certified food and tap water ad libitum during post exposure period
relative air humidity 30-70%, temperature 20-24°C, dark-light-cycle: 12h/12h

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose only

Vehicle:

other: air

Details on inhalation exposure:

Vapour-air mixture generated; temperature in exposure chamber 19-24 h; evaporation at 40°C and mixture with air; analytical control every 30 minutes during exposure.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

GC method; calibration; 7-8 samples per concentration

Duration of exposure:

4 h

Concentrations:

analytical means of 7-8 samples: 2.56+-0.9 mg/l, 3.62+-1.8 mg/l, 4.16+-2.16 mg/l

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- weighing: day 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Probit analysis according to Finney 1971

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

4.1 mg/L air (analytical)

95% CL:

3.7 - 9.5

Exp. duration:

4 h

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 3 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 3

Sex:

male/female

Dose descriptor:

LC50

Effect level:

3.7 mg/L air (analytical)

95% CL:

3.5 - 4

Exp. duration:

4 h

Mortality:

In males 5/10, 3/10, and 0/10 at high, mid, and low dose level, respectively.
In females 9/10, 7/10, and 0/10 at high, mid, and low dose level, respectively.
All rats died within 4 h after exposure.

Clinical signs:

other: During exposure: escape behavior, dyspnoea, eye and nose secretion, salivation; pale skin. After exposure: excitation, ruffled coat, bloody nose, staggered gait, tremor. All effects reversible after 2-6 days.

Body weight:

No treatment related effects.

Gross pathology:

Congestion/hyperemia in rats found dead.
No treatment related effects in survivors.

Other findings:

no

Any other information on results incl. tables

LC50 (1 h) in male and female rats combined is 15 mg/l; calculated according to Haber (C x t = k).

Applicant's summary and conclusion

Conclusions:

The LC50 (4 h) in male and female rats combined is 3.7 mg/l.

Executive summary:

The study is comparable to OECD Guideline 403.

Ten male and 10 female Wistar rats per dose were exposed to 2.56 +-0.9, 3.62 +-1.8, or 4.16 +-2.16 mg/l for 4 h; the post exposure observation period was 14 days. During exposure escape behavior, dyspnoea, eye and nose secretion, salivation, and pale skin were observed and after exposure excitation, ruffled coat, bloody nose, staggered gait, and tremor. All effects were reversible within 2 -6 days. The LC50 in males was 4.1 mg/l and in females ca. 3 mg/l. No treatment related effects were detected at necropsy.

Conclusion: The LC50 (4 h) in male and female rats combined is 3.7 mg/l.