3-methyl-5-phenylpent-2-enenitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-07-29 to 2015-09-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-phenylpent-2-enenitrile

EC Number:

299-682-2

EC Name:

3-methyl-5-phenylpent-2-enenitrile

Cas Number:

93893-89-1

Molecular formula:

C12 H13 N

IUPAC Name:

(2E)-3-methyl-5-phenylpent-2-enenitrile

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 170.0-211.1 g
- Fasting period before study: overnight
- Housing: single, Stainless wire mesh cage, 260W*350D*210H (mm)
- Diet: ad libitum, Pelleted rodent chow, Harlan Laboratories Inc. U.S.A.
- Water: ad libitum, tap water
- Acclimation period: in quarantine room 7 days, in animal room 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5-23.2
- Humidity (%): 46.3-61.3
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 60 and 400 mg/mL
- Amount of vehicle: 5 mL/kg bw
- Lot/batch no.: MKBS6944V

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: 300 mg/kg bw was selected as starting dose

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 for 300 mg/kg bw, 3 for 2000 mg/kg bw, all female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 30 min, 1, 2, 4 and 6 h, and once daily after administration; weighing: before, on day 1, 3, 7 and 14 after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

Statistical analysis was not performed.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

300 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

female

Dose descriptor:

LD100

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: 2 animals dead on day 2, 1 on day 3
300 mg/kg bw: all animals survived

Clinical signs:

other: 300 mg/kg bw: Mucous stool in 4 animals 2 h after application and in 2 animals 4 h after application. Soiled perineal region and decreased fecal volume were observed on day 1. From day 2 onward no clinical signs were observed. 2000 mg/kg bw: Abnormal gai

Gross pathology:

300 mg/kg bw: no abnormalities were detected.
2000 mg/kg bw: 2 animals had mottled yellowish-white or pale livers. Histopathology of the livers showed minimal or moderate hepatocellular vacuolation. Those hepatocytes had foamy cytoplasm and were distributed diffusely in hepatic lobes.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of the test substance was established to be in the range from 300 to 2000 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of the test substance was investigated with the acute toxic class method according to OECD Guideline 423 in rats. Experiments were conducted using GLP. The test substance was administered via gavage at 300 and 2000 mg/kg bw and the animals were observed for 14 days after treatment. All animals treated with 300 mg/kg bw showed mucous stool after administration. They recovered and no clinical signs were observed from day 2 onwards. Animals treated with 2000 mg/kg bw showed various clinical signs, e.g. loss of motor activity and hypothermia, and died on day 2 or 3 after application. The acute oral LD50 for rats was established to be in the range from 300 to 2000 mg/kg bw. Therefore the test substance was classified in category 4. H302: Harmful if swallowed