Registration Dossier

Toxicological information

Eye irritation

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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:
1973
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

Constituent 1
Chemical structure
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-[bis(carboxymethyl)amino]ethyl}(carboxymethyl)amino)acetic acid
Test material form:
solid

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