4-chlorophthalic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-chlorophthalic anhydride

EC Number:

204-179-8

EC Name:

3-chlorophthalic anhydride

Cas Number:

117-21-5

Molecular formula:

C8H3ClO3

IUPAC Name:

4-chloro-2-benzofuran-1,3-dione

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male and female New Zealand White rabbits, at least 10 weeks of age, weighing 2.22 to 2.36 kg were obtained from Millbrook Breeding Labs. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chip bedding. They were provided food and tap water ad libitum. Room temperature was 68 ± 5°F and the relative humidity ranged between 30-70%. Room lights were on a 12-hour light/dark cycle.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Approximately 24 hours prior to dosing, the application sites were prepared by clipping the skin of the trunk free of hair (not less than 10% of the body surface was clear for the application of the test substance). One half gram (0.5 g) of the test substance, moistened with water, was applied to a small area of the skin (approximately 6 cm2).

Duration of treatment / exposure:

Each application area was covered with a gauze patch and secured with non-irritating tape. Initially, three test patches were applied sequentially to a single animal and removed after three minutes, one hour and then four hours of contact to assess for possible corrosion. Once it was determined that a four-hour exposure could humanely be allowed, a single test patch was applied to two additional animals for a four-hour exposure period.

Observation period:

Dermal scores were recorded at 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. Animals were weighed at Day 0 prior to dose administration and at the end of the observation period.

Number of animals:

3

Details on study design:

Erythema and Edema formation were observed/scored based upon the Draize definition:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No erythema/edema was observed for any animal at any time period.

Other effects:

All animals gained weight over the course of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was determined to be not irritant to the skin.

Executive summary:

Skin irritation / corrosion was determined in a study performed according to OECD 404 and in compliance with GLP criteria. In this study, 3 New Zealand White rabbits (male and female) were exposed to 0.5 grams of moistened test substance on the skin, which was shaven 24 hours prior, under semi-occlusive conditions. Initially, three test patches were applied sequentially to a single animal and removed after three minutes, one hour and then four hours of contact to assess for possible corrosion. Once it was determined that a four-hour exposure could humanely be allowed, a single test patch was applied to two additional animals for a four-hour exposure period. Dermal scores, based on Draize, were recorded at 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicological and pharmacologic signs. Animals were weighed at Day 0 prior to dose administration and at the end of the observation period. No erythema/edema was observed for any animal at any time period and all animals gained weight during the study. Based on these results, the test substance was considered to be a non-irritant.