Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38 No .187 § 1500.42; adopted 1973
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohex-1,2-ylenediamine
EC Number:
211-776-7
EC Name:
Cyclohex-1,2-ylenediamine
Cas Number:
694-83-7
Molecular formula:
C6H14N2
IUPAC Name:
cyclohexane-1,2-diamine
Details on test material:
- Name of test material (as cited in study report): XXVI/645
- Physical state: liquid
- Analytical purity: 99%
- pH: 9
- ratio of cis: trans isomers: 25:75

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: own breed of the test laboratory
- Weight at study initiation: 2.3 - 2.8 kg
- Diet (e.g. ad libitum): ALTROMIN 2023, Altromin GmbH, Lage, D

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
other: olive oil
Controls:
other: the untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Treatment was once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
no

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Probable values; effects already observed 1 h after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 h
Remarks on result:
other: Effects already observed 1 h after treatment
Other effects:
Strong discharge (score 3) was observed in all readings.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the test the test substance is corrosive to the rabbit eye.
Executive summary:

An eye irritation/corrosion test was performed with six rabbits according to a FDA guideline. The animals were exposed to 0.1 ml of test substance. Strong corrosive effects were observed in all animals.