5,7-dichloro-4-hydroxyquinoline-3-carboxylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

0.5 g test substance was administered to intact and abraded skin of two rabbits, one under dry conditions and the other under wet conditions. Five consecutive daily doses of test substance were applied to the intact skin and three consecutive daily applications were made to the abraded site. Each application of test substance was applied under an occlusive dressing, held in place for a 24 hour period. The study was terminated 72 hours after the final dose administration.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

5,7-dichloro-4-hydroxyquinoline-3-carboxylic acid

EC Number:

431-250-2

EC Name:

5,7-dichloro-4-hydroxyquinoline-3-carboxylic acid

Cas Number:

171850-30-9

Molecular formula:

C10H5NO3Cl2

IUPAC Name:

5,7-dichloro-4-hydroxyquinoline-3-carboxylic acid

Details on test material:

DCHQ-acid
Appearance: white solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No further information available on test animals and environmental conditions.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

other: unchanged and 0.5% methylcellulose

Controls:

no

Amount / concentration applied:

0.5 g neat test substance under dry conditions.
0.5g neat test substance moistened with 0.3 mL of 0.5% methylcellulose for the wet patch application.

Duration of treatment / exposure:

5 consecutive daily doses (intact skin)
3 consecutive daily doses (abraded skin)

Observation period:

72 hours after the final dose.

Number of animals:

2 (one dosed under dry conditions and one dosed under wet conditions)

Details on study design:

The skin irritation test included topical application of 0.5 g of neat test substance to intact and abraded skin on the abdomen of two male New Zealand White rabbits, one under dry conditions and the other under wet conditions. The abdomen of each rabbit was shaved with a straight razor at least three days prior to test initiation. The animals were bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. To ensure sufficient contact of test substance with the skin, 0.3 mL of 0.5 % methylcellulose was used to moisten the test substance for the wet patch application.

Twenty four hours after application the bandages were removed and the application sites were graded. Five consecutive daily doses of test substance were applied to the intact skin, and three consecutive daily applications were made to the abraded abdominal site.

The study was terminated 72 hours after the final dose.

Results and discussion

In vivo

Irritant / corrosive response data:

Both animals survived the test period. No clinical signs indicative of systemic toxicity were observed. Very slight erythema was observed at the abraded dry patch site after one application and slight exfoliation was observed at the intact wet patch site after three and four doses.

Other effects:

No substantial weight change was noted over the duration of the study.

Any other information on results incl. tables

Table 1: Bodyweight in kg

Animal number	Test day 1	Test day 8
94A3123 (dry patch)	3.53	3.46
94A3138 (wet patch)	3.58	3.47

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Both animals survived the test period. No clinical signs indicative of systemic toxicity were observed. Very slight erythema was observed at the abraded dry patch site after one application and slight exfoliation was observed at the intact wet patch site after three and four doses.

Executive summary:

Under the conditions of the study, both animals survived the test period. No clinical signs indicative of systemic toxicity were observed. Very slight erythema was observed at the abraded dry patch site after one application and slight exfoliation was observed at the intact wet patch site after three and four doses. Although the reporting of the study does not include scoring of the effects observed the description of these is sufficient to conclude that classification of the substance as a skin irritant is not required.