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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:
supporting study
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The age of this study means it was not conducted according to OECD or GLP guidelines. However, the brief method outlined indicates it conformed to guidelines available at the time.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test susbtance was applied to the eyes of rabbits and observations were made after 1 and 24 hours and 8 days.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Dimethylcyclohexylamin
IUPAC Name:
Dimethylcyclohexylamin
Constituent 2
Reference substance name:
N,N-dimethylcyclohexylamine
IUPAC Name:
N,N-dimethylcyclohexylamine
Constituent 3
Reference substance name:
DMCHA
IUPAC Name:
DMCHA
Constituent 4
Chemical structure
Reference substance name:
Cyclohexyldimethylamine
EC Number:
202-715-5
EC Name:
Cyclohexyldimethylamine
Cas Number:
98-94-2
Molecular formula:
C8H17N
IUPAC Name:
N,N-dimethylcyclohexanamine
Details on test material:
- Name of test material (as cited in study report): Dimethylcyclohexylamin
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): Not documented
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: Liquid
- Analytical purity: Not documented
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: Not documented
- Expiration date of the lot/batch: Not documented
- Radiochemical purity (if radiolabelling): Not documented
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Not documented
- Other: Not documented

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No information provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 5 -20% Solution

Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
Not specified
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented
- Time after start of exposure: Not documented

SCORING SYSTEM: Not documented

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein Not documented

Results and discussion

In vivo

Irritant / corrosive response data:
Etching of the conjunctiva was observed at all time points examined, in addition to a milky opacity of the cornea. After 8 days, etching of the haw was observed, in addition to scarring and the corneal effects.
Other effects:
No other effects observed

Any other information on results incl. tables

No additional information provided.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this experiment, the test substance should be considered to be corrosive. According to Regulation EC No. 1272/20008, the test substance should be classified as Eye Dam 1 and should have the hazard phrase H318: "Causes serious eye damage" and the signal word Danger associated with it. According to Directive 67/548/5EEC, the test substance should be classified as R41 Risk of serious damage to eyes and have the symbol Xi and Danger associated with it.
Executive summary:

In a study conducted by BASF in 1960, the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eyes of rabbits to determine its potential as an eye irritant. The test substance was applied undiluted as a 5 -20% solution. Following application, the eyes were observed after 1 and 24 hours and then again after 8 days. Etching of the conjunctiva was observed 1 and 24 hours with etching of the haw observed after 8 days. Effects were also observed on corneal opacity. Under the conditions of this experiment, the test substance should be considered to be corrosive. According to Regulation EC No. 1272/20008, the test substance should be classified as Eye Dam 1 and should have the hazard phrase H318: "Causes serious eye damage" and the signal word Danger associated with it. According to Directive 67/548/5EEC, the test substance should be classified as R41 Risk of serious damage to eyes and have the symbol Xi and Danger associated with it.