Registration Dossier
Registration Dossier
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EC number: 200-573-9 | CAS number: 64-02-8
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- dose 50 mg (OECD: volume of 100 mg); 2 animals are used (OECD:3); no washing done (OECD: washing after 1 h), observation period 8 days (OECD: 21)
- 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. Usually approximately 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. 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:
- Tetrasodium ethylenediaminetetraacetate
- EC Number:
- 200-573-9
- EC Name:
- Tetrasodium ethylenediaminetetraacetate
- Cas Number:
- 64-02-8
- Molecular formula:
- C10H16N2O8.4Na
- IUPAC Name:
- tetrasodium 2-({2-[bis(carboxylatomethyl)amino]ethyl}(carboxylatomethyl)amino)acetate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum powder treated eye of the same animal
- Amount / concentration applied:
- 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
10 min, 1 h, 3 h, 24 h, 72 h, 4 d, 7d 8 days after application
READING TIME POINTS USED FOR ASSESSMENT
24 hand 72 h
SCORING SYSTEM:
For the evaluation the BASF scores given in the raw data were converted to Draize scores
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- - The talcum powder treated eye of animal 1 showed conjunctivae score grade 1 after 24 h, this effect was fully reversible within 72 h
- The talcum powder treated eye of animal 2 showed conjunctivae score grade 1 after 24 h and 72 h, this effect was not observable on day 4 - 7 but reappeared on day 8 - Other effects:
- - during the observation time a grease like layer on the eyes was observed in both animals
Applicant's summary and conclusion
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