[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

German BGA method (1991)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine

EC Number:

260-694-8

EC Name:

[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine

Cas Number:

57357-85-4

Molecular formula:

C11H21N

IUPAC Name:

1-[(1S,2S,3S,5R)-2,6,6-trimethylbicyclo[3.1.1]heptan-3-yl]methanamine

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot No.of test material: 109 + 110/91

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: comparable
- Fasting period before study: ~16 h
- Housing: single-housed in stainless steel wire mesh cages, DK-III
- Diet: ad libitum, standardized animal laboratory diet
- Water: ad libitum, tab water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4 and 44 g/100 mL
- Justification for choice of vehicle: The test substance was insoluble in water.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

200 (male and female animals), 2200 mg/kg (males only)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: General observation and mortalities was made twice each working day and once on weekends and on public holidays. Body weight determination was done shortly before administration (day 0), weekly thereafter and at the end of the study.
- Necropsy of survivors performed: Yes, at the last day of the observation period. Necropsy of all animals that died before as soon as possible.
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 200 mg/kg bw

Based on:

test mat.

Mortality:

Male animals: 200 mg/kg: no deaths; 2200 mg/kg: 3/3
Female animals: 200 mg/kg: no deaths; 2200 mg/kg: not tested

Clinical signs:

Signs of toxicity noted in the 2200 mg/kg bw dose group were: poor general state, dyspnoea, apathy, excitation, staggering, tremor, twitching, spastic gait, saltatory and flexion spasms, rolling convulsions, piloerection, and salivation.
The male animals of the 200 mg/kg bw dose group exhibited poor general state, dyspnoea, excitation, staggering, spastic gait, and piloerrection. They appeared normal 1 day after application.
The female animals of the 200 mg/kg bw dose group did not show any symptoms.

Body weight:

Male animals (200 mg/kg) : 179 g at study start, 271 g after 13 days
Female animals (200 mg/kg): 169 g at study start, 216 g after 13 days

Gross pathology:

Animals that died: diffuse reddening with blood extravasation into the lumen in the gastro-intestinal tract (2200 mg/kg: 3 males).
Sacrificed animals: no pathological findings noted (200 mg/kg; 3 males and 3 females)

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria