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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
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 191.12 of the Federal Hazardous Substances Labelling Act Regulations
Principles of method if other than guideline:
0.1 mL of test substance was instilled in the right eyes of 6 rabbits, the untreated left eye served as controls.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
Molecular formula:
C4H9NO2 (amide) & C6H11NO3 (amido ester)
IUPAC Name:
Reaction mass of N-2-hydroxyethylacetamide and N,O-diacetyl-2-aminoethanol
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of a 75% test substance solution
Observation period (in vivo):
The animals were examined after 1, 2, 3, 4 and 7 d following application.
Number of animals or in vitro replicates:
6
Details on study design:
The effects of the cornea, the iris and the conjunctivae were evaluated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
no indication of irritation
Remarks:
Result also represents 4 and 7 d time points
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Result also represents 4 and 7 d time points
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Result also represents 4 and 7 d time points
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Result also represents 4 and 7 d time points

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered to be not irritating to eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance (purity: 75%) in rabbits, according to Federal Hazardous Substances Labelling Act. In this study, 0.1 mL of test substance at a concentration of 75% in water was instilled in the right eyes of 6 rabbits and the untreated left eye served as controls. The animals were examined 1, 2, 3, 4 and 7 d following application. The effects on the cornea, the iris and the conjunctivae were evaluated. The test substance did not cause irritation to the eyes of rabbits following exposure. Under the study conditions, the test substance was therefore considered to be not irritating to eyes (South Mountain Laboratories, 1972).

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