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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium nitrilotriacetate
EC Number:
225-768-6
EC Name:
Trisodium nitrilotriacetate
Cas Number:
5064-31-3
Molecular formula:
C6H9NO6.3Na
IUPAC Name:
trisodium nitrilotriacetate
Details on test material:
Na3.NTA ("TRILON A"), liquid, 38 % aqueous
solution, not further specified (e.g. pH not stated)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
No. of animals per cage: single housing. The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system en¬sured a temperature in the range of 20 – 24°C and a relative humidity in the range of 30 – 70%. Illumination period: 12 h dark/12 h light. Acclimatization period: about 8 days before the beginning of the study. Water: daily about 250 ml per animal.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
4 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
7
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
3
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
1
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
110
Irritant / corrosive response data:
moderate erythema, slight edema and secretion after 24 h, slight erythema still visible after 72 h on 2 animals

Any other information on results incl. tables

After 24 hours, average values for redness and chemosis of the conjunctiva were 2.0 and 0.7, respectively. After 48 hours, value for conjunctival reddening was 1.0 and no chemosis was present. Conjunctival reddening was abated after 8 days. There were no findings for cornea and iris.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information

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