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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

A single application of 2000 mg/kg test material was dermally applied to two rabbits under an impervious, occlusive bandage. Residual test substance was wiped off when the bandage was removed 24 hours after application. Test animals were observed for 14 days following test substance administration.

GLP compliance:

not specified

Test type:

other: similar to standard acute method

Limit test:

yes

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

Sex:

male

Details on test animals or test system and environmental conditions:

No further information available on test animals and environmental conditions.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 0.5 % methylcellulose

Details on dermal exposure:

Animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat test substance was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. 3.0 mL of 0.5% methylcellulose was used to moisten the test material to ensure sufficient contact of the test material with the skin. Residual test material was wiped off when the bandage was removed 24 hours after application.

Duration of exposure:

24 hours

Doses:

1 dose of 2000 mg/kg

No. of animals per sex per dose:

2 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: test animals were weighed on days 1, 2, 8 and 15

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Both animals survived. There were no clinical signs indicative of systemic toxicity and no effect on bodyweight was noted.

Mortality:

Both animals survived the test period at the 2000 mg/kg dose level.

Clinical signs:

other: There were no clinical signs indicative of systemic toxicity.

Other findings:

Erythema and oedema were observed on both animals immediately after test material removal. One rabbit had erythema through test day three and the other rabbit had erythema through test day eleven.

Any other information on results incl. tables

Table 1: Bodyweights in kg

Animal number	Test day 1	Test day 2	Test day 8	Test day 15
94A0966	3.96	3.82	3.94	4.11
94A3131	3.82	3.71	3.75	3.82

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.

Executive summary:

Under the conditions of the study, the estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.