Registration Dossier
Registration Dossier
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EC number: 236-308-9 | CAS number: 13291-61-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- BASF-TEST: Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. 50 µL or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline- treated eye served as control. In studies with solids, talcum powder was used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.
- GLP compliance:
- no
Test material
- Reference substance name:
- Edetic acid
- EC Number:
- 200-449-4
- EC Name:
- Edetic acid
- Cas Number:
- 60-00-4
- Molecular formula:
- C10 H16 N2 O8
- IUPAC Name:
- 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.2; 3.32 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum treated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: ca. 50 mg - Duration of treatment / exposure:
- unspecified, substance was not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done
READING TIME POINTS
30 min, 1 h, 3 h, 24 h, 48 h, 5, 7 and 8 days after application
READING TIME POINTS USED FOR ASSESSMENT
24 and 48 h
SCORING SYSTEM:
For the evaluation the BASF scores given in the raw data were converted to Draize scores
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- - Animal 2 had a smeary overlay of the substance treated eye which disappeared within 48 h.
- Bleeding was observed in both animals on the treatment day. It was reversible within 24 h (animal 1) or 48 h (animal 2).
- The talcum treated eye of the animals showed a conjunctivae score of one which was fully reversible within 48 h.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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