Hexane-1,3,6-tricarbonitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022.06.09-2022.08.24

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 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

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)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 193-200g
- Fasting period before study: 24hours
- Housing:Full barrier in an air-conditioned room
- Historical data:
- Diet (e.g. ad libitum): libitum
- Water (e.g. ad libitum):libitum
- Acclimation period:at least 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.7 – 20.9 °C
- Humidity (%): 44 – 63%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: No less than 10% of the body surface
- Type of wrap if used: a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed with an additional dressing in a suitable manner.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 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: on day 1, days 8 and
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

One animal was administered at a dosage of 2000mg/kg bw as the starting dose. As the animal survived, this dose was used as a starting dose for the main study.

Effect levels

Sex:

female

Dose descriptor:

other: Acute Toxicity Estimate(ATE)

Effect level:

> 2 000 - <= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Body weight:

lower than 10% body weight loss

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of the present study, single dermal application of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 2000 mg/kg bw was associated with no mortality and neither signs of toxicity nor signs of irritation.
According to OECD guideline 402 [4] the test item Hexane-1,3,6-tricarbonitrile has no obligatory labelling requirement for percutaneous toxicity and is not classified.
The Acute Toxicity Estimate according to GHS (Globally Harmonized Classification System), 2021 [9] was determined to be 2000 < ATE ≤ 5000 mg Hexane-1,3,6-tricarbonitrile / kg body weight.

Executive summary:

Under the conditions of the present study, single dermal application of the test item Hexane-1,3,6-tricarbonitrile to rats at a dose of 2000 mg/kg bw was associated with no mortality and neither signs of toxicity nor signs of irritation.
According to OECD guideline 402 [4] the test item Hexane-1,3,6-tricarbonitrile has no obligatory labelling requirement for percutaneous toxicity and is not classified.
The Acute Toxicity Estimate according to GHS (Globally Harmonized Classification System), 2021 [9] was determined to be 2000 < ATE ≤ 5000 mg Hexane-1,3,6-tricarbonitrile / kg body weight.