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EC number: 200-001-8 | CAS number: 50-00-0
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Chemical burns of the rabbit cornea.
- Author:
- Carpenter CP & Smith HF
- Year:
- 1 946
- 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 substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- C H2 O
- IUPAC Name:
- formaldehyde
- Test material form:
- other: no additional information
Constituent 1
- 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.
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