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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-02-13 to 1989-02-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes

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:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: females: 121-148 g, males: 150-177 g
- Housing: individually in tiered, stainless steel animal cages
- Diet: ad libitum, no food during exposure
- Water: ad libitum, no water during exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2 °C during exposure
- Humidity (%): 42.2 during exposure

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: modular glass sections: cylindrical central animal exposure section of 11.45 L volume with top and bottom end cones of 3.31 L volume
- Exposure chamber volume: total chamber volume of 18.07 L, about 33 air change equivalents per hour
- Source and rate of air: 10 L/min
- Treatment of exhaust air: exhaust air was passed through an activated charcoal filter

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

the chamber concentration was checked in 15 minute intervals

Duration of exposure:

4 h

Concentrations:

nominal concentration: 7.8 ppm, corresponding to 62.5 mg/m^3 (calculated by the weight of the test substance divided by the volume of air passing through the exposure system)
measured concentration: 6.1 ppm (48.6 mg/m^3)
control group: 0 mg/m^3

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weights were recorded on the day of exposure and on the following days 2, 3, 4, 8 and 15 (postmortem). The animals were observed at least twice during working days and at least once at weekends for adverse toxicological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology (kidneys, liver, lungs and spleen were taken for histological examination), other: food consumption was measured at weekly intervals

- The target vapour concentration was 7 ppm, which was the maximum concentration that could be generated at room temperature, as determined in preliminary experiments without animals.

Statistics:

Body weights and organ weights were analysed for statistically significant differences using the Student's t-test.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.1 ppm

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: 6.1 ppm corresponds to 48.6 mg/m^3

Mortality:

No mortality was observed.

Clinical signs:

other: No adverse effects were observed.

Body weight:

No statistically significant differences were observed between the test and control group.

Gross pathology:

No changes were detected.

Other findings:

- Organ weights: No statistically significant differences were observed in the organs when related to the body weights.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC50 value of the test substance as a vapour was determined to be > 6.1 ppm (corresponding to 48.6 mg/m^3), which is the saturated vapour concentration.

Executive summary:

The test substance was assessed for its acute toxicity after single inhalation exposure in a 4 -hours experiment according to OECD 403. 10 Wistar rats (5 males and 5 females) were exposed to the test substance as a saturated vapour (48.6 mg/m^3) in an exposure chamber. Additionally a control group of 20 animals were exposed to air only. The exposure period was followed by a 14 -day observation period. The animals were observed and body weights were recorded at regular intervals. After 14 days, all animals were killed and subjected to post-mortem examination. The kidneys, liver, lungs and spleen were taken for histological examination. All rats survived the treatment without exhibiting clinical symptoms. No abnormalities were found at necropsy and no statistically significant differences between exposure and control group were found with regard to body weight gains or organ weights. As a conclusion, saturated vapour (48.6 mg/m^3) of the test substance was not toxic in this experiment. Therefore the LD50 was determined to be > 6.1 ppm (corresponding to 48.6 mg/m^3).