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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other:
Remarks:
Guideline study from supporting substance (structural analogue)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Illustrated Guide for Grading Eye Irritation by the Hazardous Substances
Version / remarks:
See method details in "Principles of method if other than guideline"
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The test material was not tested as the neat substance.
Principles of method if other than guideline:
The test was done as described in the "Illustrated Guide for Grading Eye Irritation by the Hazardous Substances." 0.1 mL was instilled in the right eyes of 6 rabbits; the untreated left eyes served as controls.
GLP compliance:
yes (incl. QA statement)

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
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
Duration of treatment / exposure:
not specified
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Mean of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
Mean of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Mean of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Mean of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not cuase any irritation to the eyes of rabbits treated with the material, therefore the test substance was regarded as non-irritating to the eyes as tested in rabbits.
Executive summary:

The test was done as described in the "Illustrated Guide for Grading Eye Irritation by the Hazardous Substances." 0.1 mL was instilled in the right eyes of 6 rabbits; the untreated left eyes served as controls. The test substance did not cuase any irritation to the eyes of rabbits treated with the material, therefore the test substance was regarded as non-irritating to the eyes as tested in rabbits.