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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Minor deviations to OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): divinyl ether of 1,4-cyclohexane, dimethanol

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.