Registration Dossier

Administrative data

Description of key information

1,4 -bis[(vinyloxy)methyl]cyclohexane is irritating to skin but not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Minor deviations to OECD Guideline
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
abraded and non abraded skin
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CAMM Resarch (Wayne, NJ, USA)
- Weight at study initiation: ca. 2 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18,3 -23,9 °C (65 - 75 °F)
- Photoperiod (hrs dark / hrs light): 12
Type of coverage:
semiocclusive
Preparation of test site:
other: abraded and non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2,5 cm² (flank)
- Type of wrap if used: J&J gauze sponge, Webril pad, J&J dermicel hypo-allergenic cloth tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h


SCORING SYSTEM:Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0.8
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: (non-Abraded)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: (non-abraded)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: (non-abraded)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: (non abraded)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 -72 h
Score:
3.2
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
Skin was discribed as bleached in 2/6 animal 24 h post application.
Skin was discribed as dry in 3/6 animal 72 h post application.
1/6 animals had a fisur 72 h post aplication.
Except edema after 72 h (score 2.7) results on abraded skin were in the same range as those on non-abraded skin.
Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

The study is reliable with restrictions due to some deviations to the OECD Guideline. The test substance was applied on abraded and non-abraded skin of 6 rabbits. Edema (max.3 of 4 ) and Erythem (max. 4 of 4) was observed. Primary dermal irritation index was 3.2.

The study was terminated 72 h post application and effects were not fully reversible within this time.

Conclusion

1,4 -bis[(vinyloxy)methyl]cyclohexane is irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only study summary availiable
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, (The Association of Food and Drug Officials of the United States, (1975), pp. 52 - 54.
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CAMM Research (Wayne, NJ, USA)
- Age at study initiation: approx. 3 month
- Weight at study initiation: approx. 2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23,9 °C (65 - 75 ° F)
- Photoperiod (hrs dark / hrs light): 12 h
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes of six (6) animals remained unwashed for 24 hours; the eyes of the remaining three (3) animals were washed out 30 seconds after instillation of the test article.
Observation period (in vivo):
Observations of corneal opacity, iritis, conjunctivitis, and other effects were recorded 24, 48, and 72 hours after treatment, and at day 4.
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 30 Minutes after start of exposure 3 rabbits and 24 h after start of exposure 6 rabbits.
SCORING SYSTEM:
Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: only unwashed eyes data; reverible within 4 days
Irritant / corrosive response data:
Only minimal irritation effects were observed
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The study is a guideline study according to US cosmetics regulation. However, the study is reliable with restriction because there is only a summary availiable which provides poor information concerning the test substance identity.

Nine New Zealand white rabbits, free from visible ocular defects, each received a cingle intraocular application of 0.1 milliliter of the test article. The contralateral eye, remaining untreated, served as a control. The eyes of six animals remained unwashed for 24 hours; the eyes of the remaining three animals were washed out 30 seconds after instillation of the test article. Observations of corneal opacity, iritis, conjunctivitis, and other effects were recorded 24, 48, and 72 hours after treatment, and at day 4.

The instillation of 1,4 dimethylol-divinylether cyclohexane resulted in a slight erythema (mean 0.2), but no other effect was observed for the unwashed eye. Therefore 1,4 dimethylol-divinylether cyclohexane was considered not irritating to the eyes (score 0.3 of max 110) .

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The irritation potential of 1,4 -bis[(vinyloxy)methyl]cyclohexane was examined in studies which were comparable to guideline studies.

Skin

1,4 -bis[(vinyloxy)methyl]cyclohexane was applied on abraded and non-abraded skin of 6 rabbits at semiocclusive conditions. Edema (max.3) and Erythem (max. 4) was observed. The study was terminated 72 h post application and effects were not fully reversible within this time. Primary dermal irritation index was 3.2 which is moderately irritating to the skin.

Eye

9 New Zealand white rabbits, free from visible ocular defects, received a single intraocular application of 0.1 milliliter of

1,4 -bis[(vinyloxy)methyl]cyclohexane. The contralateral eye, remaining untreated, served as a control. The eyes of six animals remained unwashed for 24 hours; the eyes of the remaining three animals were washed out 30 seconds after instillation of the test article. Observations of corneal opacity, iritis, conjunctivitis, and other effects were recorded 24, 48, and 72 hours after treatment, and at day 4. The instillation of 1,4 -bis[(vinyloxy)methyl]cyclohexane resulted in a slight erythema (mean 0.2), but no other effect was observed for the unwashed eye. Therefore, 1,4 -bis[(vinyloxy)methyl]cyclohexane is not considered irritating to the eyes (score 0.3 of max 110) .


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Classification for skin irritation (cat. 2) is warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Classification for eye irritation is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.