Carbamic acid, [(1S,2S)-3-chloro-2-hydroxy-1-(phenylmethyl)propyl]-, methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in compliance with the FDA Good Laboratory Practice Regulations 21 CFR Part 58 and OECD Guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chlorohydrine

IUPAC Name:

Chlorohydrine

Details on test material:

Test Article Description: Chlorohydrine -- white powder
Date Received: January 22, 1996
Special Handling Instructions: Standard precautions

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

physiological saline

Controls:

other: foe each animal unexposed skin area represents is its own control.

Duration of treatment / exposure:

4 hours

Observation period:

Observations for responses were recorded at 60 minutes, 24, 48 and 72 hours after unwrapping and on Days 4 and 5, according to the method of Draize.

Number of animals:

6 animals

Results and discussion

In vivo

Other effects:

Very slight to well-defined erythema with very slight to slight edema was observed 60 minutes post-unwrap, and at 48 and 72 hours and on Day 4. No necrosis was observed during the study. There was an increase in body weight of all animals during the study. The study was terminated following the Day 5 observation period.

Any other information on results incl. tables

The Primary Dermal Irritation Index is 0.5.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based upon the observations made in the Primary Dermal Irritation Study in rabbits, the test article, Chlorohydrine is a barely perceptible irritant. The Primary Dermal Irritation Index is 0.5.

Executive summary:

Chlorohydrine intermediate of saquinavir: Primary Dermal Irritation in Rabbits

This study was conducted in compliance with the FDA Good Laboratory Practice Regulations 21 CFR Part 58 and OECD Guideline 404.

The purpose of this study was to determine the potential irritant effects of *Chlorohydrine on the skin.

One group of New Zealand White rabbits (three males and three females) were used. The hair was clipped from the back prior to application of the test article. Each animal received 500 mg (moistened with 0.5 mL saline) of the test article at one dermal, semi occluded site. The patches were removed after four hours. Observations for responses were recorded at 60 minutes, 24, 48 and 72 hours after unwrapping and on Days 4 and 5, according to the method of Draize.

Very slight to well-defined erythema with very slight to slight edema was observed at 60 minutes post-unwrap, and at 48 and 72 hours and on Day 4. No necrosis was observed during the study. There was an increase in body weight of all animals during the study. The study was terminated following the Day 5 observation period.

Based upon the observations made in the Primary Dermal Irritation Study in rabbits, test article Chlorohydrine, is a barely perceptible dermal irritant. The Primary Dermal Irritation Index is 0.5.

Chlorohydrine was not a dermal irritant under the test conditions and thus, is not classified as irritating to the skin under EU criteria.