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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: meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1953
Report date:
1953
Reference Type:
publication
Title:
Unnamed
Year:
1954
Reference Type:
publication
Title:
Aliphatic and Alicyclic Amines
Author:
Benya et al.
Year:
1981
Bibliographic source:
Patty's Industrial Hygiene and Toxicology Bd. IIB

Materials and methods

Principles of method if other than guideline:
Eye injury in rabbits was recorded in a 10-grade ordinal series based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 mL of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 mL, and Grade 10 indicates a severe burn from 0.5 mL of a 1% solution in propylene glycol.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Test material form:
liquid
Details on test material:
SOURCE OF TEST MATERIAL
- Name of the test substance: Monoethylamine hydrocloride
- Expiration date of the lot/batch:
AZ01


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cold place
- Stability under test conditions: stable under storage conditions

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: propylene glycol
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): Undiluted, or as 1, 5, 15% solution in propylene glycol

Duration of treatment / exposure:
Single application
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data
Score:
9
Max. score:
10
Reversibility:
not reversible

Any other information on results incl. tables

The undiluted compound causes severe damage as do also 15 and 5 % dilutions in propylene glycol. A 1% solution causes only slight injury.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Severe damage to the rabbit eye was recorded in a study conducted with rabbits which where treated with the undiluted test compound and a 5% and 15% dilution in propylene glycol.
Executive summary:

Eye injury in rabbits was recorded in a 10-grade ordinal series based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of the chemical. The undiluted compound caused severe damage as did also 15% and 5% dilutions in propylene glycol. A 1% solution caused only slight injury.

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