Registration Dossier

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: scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Principles of method if other than guideline:
Single application of undiluted testsubstance into the conjunctival sac of one eye of rabbits (second eye served as control and was treated with saline solution. Reading after 1 hour, 24 hours and after 8 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexylamine
EC Number:
203-629-0
EC Name:
Cyclohexylamine
Cas Number:
108-91-8
Molecular formula:
C6H13N
IUPAC Name:
cyclohexanamine
Details on test material:
IUCLID4 Test substance: no further data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye of the same rabbit
Amount / concentration applied:
0.5 ml undiluted test substance
Duration of treatment / exposure:
single application
Observation period (in vivo):
up to 8 days
Number of animals or in vitro replicates:
no data
Details on study design:
Single application of undiluted testsubstance into the conjunctival sac of one eye of rabbits (second eye served as control and was treated with saline solution. Reading after 1 hour, 24 hours and after 8 days.(scoring not given)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Overall irritation based on mean with time point 1h, 24 hours and 8 days readings: mucous membranes etched, marked erythema, marked edema, cornea opacity, irrreversible effect. Scores not given.
Additional findings: after 1 hour, hemorrhage observed, score not given, after 8 days, staphyloma observed, score not given.

Overall irritation controls provided no finding.
Other effects:
no data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
corrosive
Executive summary:

Single application of undiluted testsubstance into the conjunctival sac of one eye of rabbits (second eye served as control) and was treated with saline solution. Reading was done after 1 hour, 24 hours and after 8 days.(scoring not given). the testsubstance was corrosive to the mucouse membraines and caused hemorrhage and severe not reverible lesions (BASF 1970).