2,2,3-trimethylcyclopent-3-enylacetonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD and GLP conform study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,3-trimethylcyclopent-3-enylacetonitrile

EC Number:

239-405-4

EC Name:

2,2,3-trimethylcyclopent-3-enylacetonitrile

Cas Number:

15373-31-6

Molecular formula:

C10H15N

IUPAC Name:

2-(2,2,3-trimethylcyclopent-3-en-1-yl)acetonitrile

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld, Germany
- Weight at study initiation: m: 246.3 - 251.6 g f: 195.3 - 203.1 g
- Fasting period before study: 16 h
- Housing: collective caging
- Diet: ad libitum Ssniff-R Alleindiät für Ratten (Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen, Germany)
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-80
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw were applied.

Doses:

One limit dose of 2 mL/kg bw were applied.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not required

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 021 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 021 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No clinical symproms were observed.

Gross pathology:

No macroscopic findings in the cranial-, thoracic- and abdominal cavity were found.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value was found to be greater than 2021 mg/kg bw in rats.

Executive summary:

The acute oral toxicity was investigated in one group of 5 fasted male and 5 female Wistar-rats. One (limit) concentration of 2021 mg/kg bw was applied by gavage. Any signs of toxicity were recorded during the 14 days observation period and the animals were subjected to necropsy afterwards. As a result, no mortalities were observed and also no clinical signs were noted. At necropsy, no abnormalities were observed. As a result, the LD50 was determined to be 2021 mg/kg bw.