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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
This study was conducted in accordance with Standard Operating Procedures, Good Laboratory Practice Standards as set forth by the EPA in 40 CFR Part 160 (FIFRA) and 40 CFR Part 792 (TSCA), JMAFF in NohSan No. 3850, and OECD in (C(81)30(Final)Annex 2), and the Protocol as approved by the Sponsor. Procedures pertinent to this study are described in this report.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc., Kalamazoo, Michigan.
- Age at study initiation: 7.5 months of age
- Weight at study initiation: The body weight range on the day of dosing was 3283-3519 grams.
- Housing: housed in individual stainless steel slatted floor cages in an animal room
- Diet: Certified Rabbit Chow® # 5322, PMI Feeds, Inc., St. Louis, Missouri was available up to 125 g/day.
- Water: ad libitum
- Acclimation period: The animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication entitled "Guide for the Care and Use of Laboratory Animals" and conditioned for a period of 114 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 66-68°F
- Humidity: 56-66%
- Photoperiod: 12 hours light and 12 hours dark

IN-LIFE DATES: From: May 12,1997 To: September 8, 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after bandage removal
Number of animals:
6 male
Details on study design:
Each rabbit was identified by a Monel® metal ear tag bearing the individual animal number.

TEST SITE
- Area of exposure: 1 intact skin site on the back of each rabbit. Dorsal area
- Type of wrap if used: The test sites were then wrapped with 8-ply gauze bandaging and overwrapped with Denniform® tape. A collar (E-Jay Saf-T-Shield) was placed on each rabbit to prevent them from disturbing the application site and wrapping.

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

SCORING SYSTEM: Draize

Results and discussion

In vivo

Irritant / corrosive response data:
The test sites were evaluated for dermal irritation approximately 0.5-1, 24, 48, and 72 hours following patch removal and scored based on the Draize method. All scores at each observation interval were 0 for each animal.
Other effects:
No signs of ill health or test article-related effects were observed during the study.

Any other information on results incl. tables

The overall irritation score was 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, Acetonitrile (HPLC Grade) is non-irritating to the skin of rabbits.
Executive summary:

In a guideline (OECD 404 equivalent) and GLP study, Acetonitrile (HPLC Grade) was found to be non-irritating to the skin of rabbits (4 -hour exposure). All scores at each observation interval were 0.0 for each animal. No other signs of ill health or test article-related effects were observed during the study.