Formaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

limited documentation, sufficient for assessment of the irritant/corrosive effects

Cross-reference

Reason / purpose:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Chemical burns of the rabbit cornea.

Author:

Carpenter CP & Smith HF

Year:

1946

Bibliographic source:

Am J Ophthal 29: 1363-1372

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 rabbits received instillation of 0.005 mL of 15% formaldehyde. Eye irritation was scored 18-24 h later.

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: no additional information

Specific details on test material used for the study:

No data

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

water

Controls:

other: Yes, untreated eye of the same rabbit. Furthermore grade one substances (but not concurrent) test.

Amount / concentration applied:

15%

Duration of treatment / exposure:

18-24 h

Observation period (in vivo):

Eye scorred 18-24 h after application

Number of animals or in vitro replicates:

5

Details on study design:

- Preparation of test substance: Test substance was prepared by mixing of test substance with water.
- Amount of active substance instilled: 0.005 ml
- Concentration in vehicle: 15%
- Removal of test substance: unwashed
- Duration of exposure: ca. 24 h
- Postexposure period: No
- Clinical signs: No data
- Examination time points: 18-24 h after application
- Further remarks: Study on 180 different substances; TS applied to the center of the cornea (lids retracted) in different concentrations and volumes and scored 18-24 h later, usually 5 rabbits per group; symptoms scored before fluorescein staining (cornea opacity, max 6 points; iritis, max 2 points; keratoconus 6 points) and after staining (necrosis of cornea evaluated, max. 6 points); max. of 20 points possible (6+6+2+6).
A level of totally 5 points (mean of 5 animals) is representative of severe injury.
10 injury grades (max. 10: sodium hydroxide, 0.005 ml of a 1% solution resulted in > 5 points).

Results and discussion

In vivo

Results

Irritation parameter:

other: injury

Basis:

mean

Time point:

other: 18-24 h

Reversibility:

not specified

Irritant / corrosive response data:

- Erythema: No data
- Edema: No data
- Reversibility: No data
- Other examinations: Application resulted in injury grade 8: 0.005 mL 15% formaldehyde solution yielded scores over 5.0 points (severe injury). 0.005 mL of 5% solution resulted in not more than 5.0 points.
It is stated in this study that formaldehyde has caused severe eye injury in humans (no details).

Overall result: A very small amount of the test substance resulted in a mean of > 5 points.

Any other information on results incl. tables

Formaldehyde was in the grade 8 group together with ethylene diamine or dimethyl sulphate, which are corrosive substances.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Indications for corrosive properties.

Executive summary:

The study meets scientific standards with acceptable restrictions (limited documentation) and is sufficient for assessment of the irritant/corrosive effects.

5 rabbits received single instillation of 0.005 mL of 15% formaldehyde. Eye irritation was scored 18-24 h later.This treatment resulted in a score >5 and caused severe injury.

There are indication for corrosive properties.