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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
6th June 1977 to 11thNovember 1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Not compliant with guidelines or GLP. Skin was abraded prior to application of the test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied to rabbits to determine its potential skin irritancy.
GLP compliance:
not specified

Test material

Constituent 1
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): Polycat 8
- 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.: 73-270 CJ
- 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

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: 2.33 - 2.55kg
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: 10 November 1977 To: 11 November 1977

Test system

Type of coverage:
not specified
Preparation of test site:
other: Intact and abraded shaved skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
No information provided
Observation period:
30 days post application. Readings were made at 4, 24, 48 and 72 hours post application.
Number of animals:
6 animals
Details on study design:
No information provided

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 hours
Score:
1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
other: Corrosion Score
Basis:
mean
Time point:
other: 4 hours
Score:
3
Max. score:
3
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
other: Corrosion Score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
other: Corrosion Score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritation parameter:
other: Corrosion Score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: For both intact and abraded skin
Irritant / corrosive response data:
Following exposure to rabbits, the test substance was considered to be extremely irritating to the skin of the rabbits.
Other effects:
No additional information

Any other information on results incl. tables

No additional information provided

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the conditions of this study, the test substance, DMCHA, should be considered to be irritating, based on the results observed following exposure to rabbits. Based on these results, the test substance should be classified as a Category 1B skin corrosion/irritant and have the signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.
Executive summary:

In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was tested for its ability to cause irritation when applied to the skin of 6 rabbits. The skin of the test animals was either intact or abraded and 50ml of test substance was applied to each rabbit. Readings on erythema, oedema and corrosion score were made at 4, 24, 48 and 72 hours post application and observations continued for 30 days post application. Under the conditions of this study, the test substance, DMCHA, should be considered to be irritating, based on the results observed following exposure to rabbits. Based on these results, the test substance should be classified as a Category 1B skin corrosion/irritant and have the signal word Warning and the hazard statement H314: Causes severe skin burns and eye damage

associated with it, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.