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Toxicological information

Eye irritation

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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.