Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-02-08 to 1985-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

no

Remarks:

but QA statement available

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

EC Number:

919-489-5

Molecular formula:

C13H23N

IUPAC Name:

Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile

Test animals

Species:

rat

Strain:

other: BOR: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 174.4 - 192.2 g; females: 152 - 180 g
- Fasting period before study: 16 h
- Housing: collection caging in Macrolon type III/max 5 rats
- Diet: Ssniff Spezialfutter GmbH (Soest, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 7 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50-85
- 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: 5 mL/ kg bw

Doses:

only one (limit) concentration of 5 mL (according to appr. 4165 mg/kg bw calculated using a densitiy of 0.833 mg/cm^3)

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: on day 0 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (at 20 min, 1 h, 2 h, 3 h, 6 h, 24/38 h, 7/14 days)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 165 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was recorded.

Clinical signs:

The sample induced in the tested dosage no clinical-toxicological symtoms.

Body weight:

Post -dosing weight gains (2 week values) of all animals did not show essential differences.

Gross pathology:

Nothing abnormal was found in the animals necropsied an day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value was determined to be > 4165 mg/kg bw.

Executive summary:

The acute oral toxicity of the test substance was investigated in a study according to OECD 401. One group of 5 male and 5 female rats of the WISW-strain was used. Based on a range finding study, one limit dose of 5000 µL/kg bw undiluted test substance (corresponding to 4165 mg/kg bw) was applied by gavage. Any signs of reaction and mortalities were recorded during the 14-day observation period, animals which died and those killed terminally were subjected to necropsy. The test substance did not induce clinical-toxicological symptoms. Post -dosing body weight gains (2 week values) of all animals did not show essential differences. No mortalities were observed. No changes were observed in the animals necropsied on day 14. Based on these findings, the LD50 value for acute oral toxicity in rats was determined to be > 4165 mg/kg bw.