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

Eye irritation

Administrative data

Endpoint:

eye 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:

0.1 g test substance was instilled into each conjunctival sac of a rabbit. One eye was washed with water after a 30 second exposure, while the other eye was washed with water after one hour. Eye reaction to the test substance was assessed over a 72 hour period following instillation.

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No further information available on test animals and environmental conditions.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g neat test substance

Duration of treatment / exposure:

One eye was washed with water after a 30 second exposure.
The other eye was washed with water after 1 hour exposure.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1

Details on study design:

The eye irritation test included instillation of 0.1 g of neat test substance into each conjunctival sac of a female New Zealand White rabbit that had been screened for ocular defects and irritation 24 hours prior to dosing. One eye was washed with water after a 30-second exposure, while the other eye was washed with water after one hour. Irritation, in both eyes, was assessed for a period of 72 hours following instillation of the test substance.

Results and discussion

In vivo

Irritant / corrosive response data:

Very slight to slight conjunctival redness and swelling was observed in the 30 second exposure eye and very slight to moderate conjunctival response was observed in the hour exposure eye. No clinical signs indicative of systemic toxicity were observed in the animal. Irritation in both eyes was cleared by 72 hours after instillation of the test substance and the study was terminated.

Other effects:

The animal survived the test period.
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 4
94A3615	3.51	3.60

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Very slight to slight conjunctival redness and swelling was observed in the 30 second exposure eye and very slight to moderate conjunctival response was observed in the hour exposure eye. No clinical signs indicative of systemic toxicity were observed in the animal. Irritation in both eyes was cleared by 72 hours after instillation of the test substance.

Executive summary:

Under the conditions of the study, very slight to slight conjunctival redness and swelling was observed in the 30 second exposure eye and very slight to moderate conjunctival response was observed in the hour exposure eye. No clinical signs indicative of systemic toxicity were observed in the animal. Irritation in both eyes was cleared by 72 hours after instillation of the test substance.

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 an eye irritant is not required.