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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
eye irritation, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP status unknown, near guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviation did not impact the scientific validity of the study.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexane
EC Number:
203-806-2
EC Name:
Cyclohexane
Cas Number:
110-82-7
Molecular formula:
C6H12
IUPAC Name:
cyclohexane
Details on test material:
Not reported

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not reported

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
Not reported
Duration of treatment / exposure:
Not reported
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
cornea
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Remarks:
iris
Basis:
mean
Time point:
other: 1 h
Score:
0.8
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Remarks:
conjunctivae
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
other: total (cornea, iris and conjuctivae)
Time point:
other: 1 h
Score:
3.7
Reversibility:
fully reversible within: 24 h

Any other information on results incl. tables

The report states that corneal opacity (involving up to 25% of the cornea) was noted in one rabbit and iritis in another 1 hr post-instillation however the rapid reversibility of these responses (both fully resolved by 24 hr) suggests possible over-interpretation. Conjunctival redness was also noted in 5 rabbits with conjunctival chemosis in one, however responses again cleared within 24 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Conclusions:
Slight eye irritation effects were present 1 hour after instillation but had resolved within 24 hours.
Executive summary:

Slight eye irritation effects were present 1 hour after instillation but had resolved within 24 hours.