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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:
weight of evidence
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:
1970
Report date:
1970

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

Constituent 1
Chemical structure
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',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Test material form:
solid

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, 48 h, 4 d, 7d 8 days after application

READING TIME POINTS USED FOR ASSESSMENT
24 hand 48 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:
1.25
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:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.75
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.25
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: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
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:
- Both animals had effects on the cornea, conjunctivae and showed chemiosis.
- Additionally there was a suppuration of the treated eye in animal 2. This effect was reversible within 8 days.
- The talcum treated eye of animal 2 showed conjunctivae score 1 after 24 h, which was fully reversible within 48 h. In animal 1 no effects on the talcum treated eye were observed 24 h after application.
Other effects:
- on day 7 animal 2 suffered from diarrhea did not eat. These symptoms disappeared on day 8.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria met; classification required according to Regulation (EC) No. 1272/2008
Conclusions:
In this eye irritation test, performed with source substance tetrasodium dihydrogen EDTA (CAS 64-02-8), instillation of 50 mg of of the test item to the eye of two rabbits resulted in redness (score 1.75), edema (score 1.25) and opacity (score 1.3) and pus formation as average 24/48/72 h after application. After 8 days still a mild opacity was seen.

For this substance there exists a CLP harmonized classification as Eye Dam. 1.