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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
300 mg/kg bw
Based on:
test mat.
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:
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 gait, lacrimation, salvation, decreased fecal volume, tremor, tonic convulsion, hypersensitivityy, loss of locomotor activity, lying on side and hypothermia were observed starting 4-6 h after treatment and worsening on day 1 and 2 after application.
Body weight:
300 mg/kg bw: decrease ob body weight or supressed body weight gain were observed in 3 animals on day 1. Normal body weight gain was obserevd from day 3 onwards.
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