Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Several studies are available for both skin and eye irritation.  The test species used was the rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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.
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
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
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
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

No additional information provided

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.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not documented
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient information to determine reliability
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF internal test procedure
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No information provided
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 -20% solution
Duration of treatment / exposure:
Not documented
Observation period:
8 days.
Number of animals:
Not documented
Details on study design:
TEST SITE
- Area of exposure: Backs and ears
- % coverage: Not documented
- Type of wrap if used: Not documented

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided
- Time after start of exposure: Not relevant

SCORING SYSTEM: No information
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Reversibility:
no data
Remarks on result:
other: light erythema was observed
Irritation parameter:
other:
Basis:
mean
Time point:
other: 8 days
Reversibility:
no data
Remarks on result:
other: Necrosis was observed
Irritant / corrosive response data:
Following 24 hours, light erythema was observed. After 8 days observations, necrosis was observed.
Other effects:
No information provided

Corrosive

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Under the conditions of this study, the test material was considered to be corrosive. Based on these results, the test substance should be classified as Category 1C skin corrosive/irritant and should have the signal word 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 BASF in 1960, the test substance cyclohexyldimethylamine (DMCHA) was applied to the backs and ears of rabbits to determine its potential skin irritancy. The test substance was applied undiluted and observations were made at 1, 5, 15 and 20 hours, with recordings made after 24 hours and 8 days. Following 24 hours, light erythema was observed. After 8 days observations, necrosis was observed. Under the conditions of this study, the test material was considered to be corrosive. Based on these results, the test substance should be classified as Category 1C skin corrosive/irritant and should have the signal word 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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.
Reason / purpose for cross-reference:
reference to same study
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
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No information provided
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
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

No additional information provided.

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.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
6th June 1977 to 11th November 1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study is not OECD or GLP compliant. Insufficient information to determine reliability.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied to the eyes of rabbits to determine its irritancy potential.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: 2.33 to 2.51kg
- 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: To: Not documented
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.10ml
Duration of treatment / exposure:
Test 1: 5 minute exposure
Test 2: 24 hour exposure
Observation period (in vivo):
Test 1: 48 hour observations
Test 2: 72 hours observation
In both test, the animals reactions were observed for 30 days post application.
Number of animals or in vitro replicates:
8 test animals
Details on study design:
No information provided.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 5 minutes
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 5 minutes
Score:
1
Max. score:
1
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hour
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 5 minutes
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Following 5 minutes exposure
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Following 24 hour exposure
Irritant / corrosive response data:
Following application to the rabbits eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints.
Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy efects with no reduction at the 48 hour observation time-point.
Other effects:
Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded.

No additional information provided

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the test substance, DMCHA should be considered to be corrosive to the eye. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.
Executive summary:

In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eye of 8 rabbits to determine its ability to cause irritancy. The test substance was applied at a concentration of 0.10 ml for 5 minutes exposure (Test 1) and a 24 hour exposure (Test 2) in two separate tests. Observations were made at 5 minutes, 24 hours and 48 hours in Test 1 and at 24 hours, 48 hours and 72 hours in Test 2. Observations continued for 30 days post application. Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded. Following application to the rabbits eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints. Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy efects with no reduction at the 48 hour observation time-point. Under the conditions of the study, the test substance, DMCHA should be considered to be corrosive to the eye. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

On consideration of all the information presented, it is possible to conclude that the test substance in question, cyclohexyldimethylamine (DMCHA), is corrosive to the skin and a severe eye irritant. While the studies were not fully compliant with the relevant current guidelines, they were conducted sufficiently well, according to Guidelines extant at the time of the study. In addition, as all the studies presented had the same findings, it can be assumed that classification of 'Corrosive' is appropriate.

Skin Irritation:

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 substance should be classified as a Category 1B skin corrosion 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 an Corrosive (C) and should have the risk phrase R34 : Causes burns, associated with it.

Eye Irritation:

In a study conducted by Katz (1977), the test substance, cyclohexyldimethylamine (DMCHA), was applied to the eye of 8 rabbits to determine its ability to cause irritancy. The test substance was applied at a concentration of 0.10 ml for 5 minutes exposure (Test 1) and a 24 hour exposure (Test 2) in two separate tests. Observations were made at 5 minutes, 24 hours and 48 hours in Test 1 and at 24 hours, 48 hours and 72 hours in Test 2. Observations continued for 30 days post application. Upon application of the test substance to the rabbit eyes, the rabbits were in considerable stress, with screaming and hyperactivity recorded. Following application to the rabbits' eyes, there were severely irritating effects seen following the 24 hour exposure period on the corneas, iris and conjunctivae with no improvement/reduction in effects observed at subsequent observation timepoints. Following the 5 minute exposure, readings made at the 24 hour time-point indicated severe irritancy effects with no reduction at the 48 hour observation time-point. Under the conditions of the study, the test substance, DMCHA should be considered to be a severe eye irritant. Based on these results, the test substance should be classified as a Category 1 eye irritant with the signal word Danger and the hazard statement H318: Causes serious eye damage associated with, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as an Irritant (Xi) and have the risk phrase R41 Risk of serious damage to eyes associated with it.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin Irritation/Corrosion:

On the basis of the results in the studies conducted, the test substance should be classified as Skin Corrosion/irritation 1B and have 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 R34 Causes burns and have the symbol C and the word Corrosive associated with it.

Eye Irritation/Corrosion:

On the basis of the results in the studies conducted, the test substance should be classified as Eye Dam 1 and have the hazard statement H318: Causes serious eye damage associated with it, in accordance with Regulation EC No. 1272/2008.

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 Irritant associated with it.