Acetonitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetonitrile

EC Number:

200-835-2

EC Name:

Acetonitrile

Cas Number:

75-05-8

Molecular formula:

C2H3N

IUPAC Name:

acetonitrile

Details on test material:

- Name of test material (as cited in study report): Acetonitrile HPLC Grade
- Physical state: Clear liquid
- Analytical purity: 99.9%
- Impurities (identity and concentrations): Water: 0.002%
- Lot/batch No.: 973432
- Storage condition of test material: Room temperature
- Supplier: Fisher Chemicals, Fair Lawn, New Jersey

Specific details on test material used for the study:

- Name of test material (as cited in study report): Acetonitrile HPLC Grade
- Physical state: Clear liquid
- Analytical purity: 99.9%
- Impurities (identity and concentrations): Water: 0.002%
- Lot/batch No.: 973432
- Storage condition of test material: Room temperature
- Supplier: Fisher Chemicals, Fair Lawn, New Jersey

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc. Kalamazoo, MI.
- Age at study initiation: 3.5 months of age.
- Weight at study initiation: 2721 - 3035g (m); 2477 - 2884g (f)
- Housing: Individually in stainless-steel cages.
- Diet: Certified Rabbit Chow® # 5322 ad libitum
- Water: Ad libitum
- Acclimation period: 8 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 66 - 70°F
- Humidity: 46 - 80%
- Photoperiod: 12 hours a day light

IN-LIFE DATES: From: August 11, 1997 To: September 18, 1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The test article was applied to the shaven intact skin on the back of each rabbit.
- % coverage: approximately 15% of body surface.
- Type of wrap if used: The trunk of each rabbit was wrapped with gauze bandaging and secured with Dermiform® tape.

REMOVAL OF TEST SUBSTANCE
- Following the exposure period, the bandaging materials and collars were removed and the test sites wiped with disposable toweling moistened with water to remove any residual material.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The dosage volume was 2.6 mL/kg based on a test article density of 0.777 g/mL.

Duration of exposure:

24 hours.

Doses:

Single 2000 mg/kg dose.

No. of animals per sex per dose:

5 males and 5 females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes. A gross necropsy was performed on all animals at study termination (study day 15). Euthanasia was by an overdose injection of sodium pentobarbital.

Statistics:

No data were analyzed statistically.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived to study termination.

Clinical signs:

other: No signs of toxicity or ill health were observed in the males during the conduct of this study. With the exception of decreased defection observed in 3 females for 1 day during the 14-day observation period ( which was described as a probable test articl

Gross pathology:

At necropsy, no visible abnormalities were observed at the application site or in other tissues.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the acute dermal LD50 value of Acetonitrile (HPLC Grade) is greater than 2000 mg/kg for male and female rabbits.

Executive summary:

In a guideline (OECD 402 equivalent) and GLP study by MPI Research (1998), the acute dermal LDLo (24 -hour exposure) of Acetonitrile (HPLC Grade) was found to be greater than 2000 mg/kg for male and female rabbits. No signs of toxicity or ill health were observed in the males during the conduct of this study. With the exception of decreased defection observed in 3 females for 1 day during the 14-day observation period (which was described as a probable test article-related change), no other signs of ill health or toxicity were observed in the females during the study.