(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because inhalation of the substance is likely

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Method not detailed. Six male and six female Fischer 344 rats, and female C57BL/6 mice were exposed to varying concentrations of test material vapor for calculating LC50.

GLP compliance:

no

Remarks:

Prior to GLP but conducted according to the "Guide for the Care and Use of Laboratory Animals," Institute of Laboratory Animal Resources, National Research Council.

Test type:

acute toxic class method

Limit test:

no

Species:

other: rats and mice (and hamsters)

Strain:

other: Fischer 344 rats ; C57BL/6 mice ; Goden Syrian hamsters

Sex:

male/female

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chamber
- Exposure chamber volume: 9 L

Duration of exposure:

ca. 4 h

Remarks on duration:

6h for hamsters

Concentrations:

Rats and hamsters : Not reported ("varying concentrations")
Mice: varying concentrations including 1000 ppm

No. of animals per sex per dose:

6 rats/sex. 6 female mice. Not specidied for hamsters.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 1 221 ppm

Based on:

test mat.

95% CL:

ca. 1 174 - ca. 1 259

Exp. duration:

4 h

Remarks on result:

other: rats

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 1 194 ppm

Based on:

test mat.

95% CL:

ca. 1 107 - ca. 1 287

Exp. duration:

4 h

Remarks on result:

other: rats

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 930 ppm

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: mice

Remarks:

An exact LC50 was not obtained as the difference between zero and 100% mortality was so slight that an attempt to achieve partial mortality was not made. A concentration of 900 ppm resulted in no deaths while 955 ppm caused complete mortality.

Mortality:

Yes but no details.

Clinical signs:

other: Eye irritation, fine tremors, prostration, ataxia. Death during exposure was preceded by clonic convulsions. Survivors of high concentrations exhibited hind quarter paralysis.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the test conditions, the estimated inhalation LC50 after a 4-hour exposure period were 1221 and 1194 ppm for male and female rats, respectively and 930 ppm for female mice. Therefore, the test substance is classified in Category 3 for acute toxicity by inhalation.

Executive summary:

In an acute inhalation toxicity study performed in 1979, six male and six female Fischer 344 rats, and female C57BL/6 mice were exposed to varying concentrations of test material during 4 hours. Male Golden Syrian hamsters were exposed to saturated vapor pressure concentrations during 6 hours.

Gross signs of toxicity during exposure included tremors and ataxia.

Death during exposure was preceded by fine tremors, prostration and clonic convulsions. Survivors of high concentrations exhibited hind quarter paralysis which lasted throughout the 14 -day observation period or to time of death, whichever occured first.

No mortality was observed in hamsters.

All of 6 mice exposed to 1000 ppm died within 4 hours.

LC50 (M rats) = 1221 (1174 -1259) ppm, ca. 6803 (6542 - 7015) mg/m3, ca. 6.803 (6.542 - 7.015) mg/L.

LC50 (F rats) = 1194 (1107 -1287) ppm, ca. 6653 (6168 - 7171) mg/m3, ca. 6.653 (6.168 - 7.171) mg/L.

LC50 (F mice) = 930 ppm (Confidence limits could not be calculated), ca. 5182 mg/m3, 5.182 mg/L.

Under the test conditions, the substance is classified in Category 3 for acute toxicity by inhalation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute inhalation toxicity endpoint.