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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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