Hexane-1,3,6-tricarbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022.06.9-2022.09.21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Hexane-1,3,6-tricarbonitrile

EC Number:

217-199-7

EC Name:

Hexane-1,3,6-tricarbonitrile

Cas Number:

1772-25-4

Molecular formula:

C9H11N3

IUPAC Name:

hexane-1,3,6-tricarbonitrile

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISTAR rats Crl: WI(Han) (full barrier)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 175-180g
- Fasting period before study: 16-18 hours
- Housing: Full barrier in an air-conditioned room
- Historical data: none
- Diet (e.g. ad libitum): libitum
- Water (e.g. ad libitum):libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.7 – 21.4 °C
- Humidity (%): 40 – 63%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Based on OECD Guideline 423, Annex2

MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the LD50 value in rats was estimated to be 1200 mg/kg bw

Doses:

2000, 300 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every 7 days
- Necropsy of survivors performed: yes
- Clinical signs including body weight: none

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50 cut-off

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 2000 mg/kg bw was associated with signs of toxicity and mortality.
Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 300 mg/kg bw was associated with signs of toxicity but no mortality.

Body weight:

lower than 10% body weight loss

Remarks:

None of the animals showed weight loss during the observation period except for the animal No. 6 which showed a weight loss of 13% on the day 5 post-dose, but gain the weight of 9 % till end of the study

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 2000 mg/kg bw was associated with signs of toxicity and mortality.
Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 300 mg/kg bw was associated with signs of toxicity but no mortality.
The median lethal dose of Hexane-1,3,6-tricarbonitrile after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 2000 mg/ kg bw
On the basis of the test results and in conformity with the criteria given in GHS (Globally Harmonized System of Classification and Labelling of Chemicals), the substance should be classified into Category 4: > 300 – 2000 mg/kg bw.

Executive summary:

Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 2000 mg/kg bw was associated with signs of toxicity and mortality.
Under the conditions of the present study, a single oral application by gavage of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 300 mg/kg bw was associated with signs of toxicity but no mortality.
The median lethal dose of Hexane-1,3,6-tricarbonitrile after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 2000 mg/ kg bw
On the basis of the test results and in conformity with the criteria given in GHS (Globally Harmonized System of Classification and Labelling of Chemicals) [9], the substance should be classified into Category 4: > 300 – 2000 mg/kg bw.