Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 December 1976 - 4 March 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was performed pre-GLP and similar to OECD guideline 401. However, the materials, methods and results are reported clearly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

two animals tested in lowest and highest dose group

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

EC Number:

916-331-7

Molecular formula:

C14H20O2

IUPAC Name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

Test material form:

liquid

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Fasting period before study: 4 hours
- Housing: individual cages
- Diet: commercial pelleted diet ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
-No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
-10.0 ml/kg bw

RATIONALE FOR THE SELECTION OF THE STARTING DOSE:
-A range-finding test is performed for each test material to determine an approximate order of toxicity using 5 male en 5 female animals. In this test, which is used for suspected low toxic materials, the most relevant dose-level for the class of substance is selected. Three male and three female animals are dosed at this level, and one male en one female dosed both above and below this level.

Doses:

-10.0 ml/kg bw
-5.0 ml/kg bw
-2.0 ml/kg bw

No. of animals per sex per dose:

-10.0 ml/kg bw 1 male and one female
-5.0 ml/kg bw 3 males and 3 females
-2.0 ml/kg bw 1 male and one female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 9 733 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: The mice dosed at 5.0 ml/kg and 10.0 ml/kg were hypothermic and showing signs of stress within 30 mins. after treatment. After 18 hours all mice except for the male mouse dosed at 10.0 ml/kg had recovered, and this animal recovered within 42 hours. The mi

Gross pathology:

At autopsy pale intestines, and mottled liver, kidneys and spleens were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not acute orally toxic

Remarks:

according to EU CLP (EC1272/2008 and its amendments)

Conclusions:

No mortality was observed, resulting in an approximate acute LD50 value of >10.0 ml/kg bw corresponding to >9733 mg/kg. It can be concluded that Cyclabute was not acute toxic via the oral route under the conditions of this test.

Executive summary:

An acute oral range-finding toxicity test was performed with oral intubation in 4 -5 week old white mice. Three doses were tested: 2.0 ml/kg (1 male/ 1 female) 5.0 ml/kg (3 male/ 3 female) and 10.0 ml/kg (1 male/ 1 female), corresponding to 1945, 4867, and 9733 mg/kg bw.Animals were observed for 7 days after intubation.

The mice dosed at 5.0 ml/kg and 10.0 ml/kg were hypothermic and showing signs of stress within 30 minutes after treatment. After 18 hours all mice except for the male mouse dosed at 10.0 ml/kg had recovered, and this animal recovered within 42 hours. The mice dosed at 2.0 ml/kg appeared unaffected by the treatment. All mice gained weight during the 7 day observation period. No animals died during observation period. All survivors were killed and examined post mortem after 1 week, at autopsy pale intestines, mottled livers, kidneys and spleens were observed. An approximate acute LD50 value of >10.0 ml/kg bw corresponding to >9733 mg/kg, was identified. Based on these results, Cyclabute does not need to be classified as acute toxic via the oral route in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC, under the conditions of these test.