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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: Non-GLP, non-guideline, animal experiment study, published in peer reviewed literature, limitations in design and/or reporting but otherwise adequate for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Streigel JA, Nycum JS
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. Vol 30, 470-476
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC and Streigel JA
Year:
1962
Bibliographic source:
Am Indust Hyg Assoc 23, 95-107

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.01 mL of either undiluted or a solution in water, propylene glycol or acetone applied to the clipped skin of a group of 5 albino rabbits and left uncovered. Signs of skin irritation / corrosion assessed 24 hours after application on a 1-10 scale.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-vinylcyclohexene
EC Number:
202-848-9
EC Name:
4-vinylcyclohexene
Cas Number:
100-40-3
Molecular formula:
C8H12
IUPAC Name:
4-vinylcyclohexene
Constituent 2
Reference substance name:
4-vinyl-1-cyclohexene
IUPAC Name:
4-vinyl-1-cyclohexene
Details on test material:
Name of test material (as cited in study report): 4-vinyl-1-cyclohexene

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: Many test materials were investigated in the study. The authors report materials were either undiluted or a solution in water, propylene glycol or acetone
Controls:
no
Amount / concentration applied:
0.01 mL
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: Not reported
- Type of wrap if used: None

REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: On a 1-10 scale, based on the severest reaction that developed on clipped rabbit skin (where 1 = no irritation, 2= the least visible capillary injection, 6 = necrosis when applied undiluted, 10 = necrosis when applied as a 0.01% solution)

Results and discussion

In vivo

Results
Irritation parameter:
other:
Basis:
other:
Time point:
other: most severe reaction within 24 h of application
Score:
4
Max. score:
10
Reversibility:
no data
Remarks on result:
other: 4 on a 0-10 scale where grade 6 indicated necrosis when undiluted. Assessment at 24 hours only
Irritant / corrosive response data:
No detail

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
4-vinylcyclohexene is no more than a moderate irritatant to rabbit skin (4 on a 1-10 scale where grade 6 indicated necrosis when undiluted) following a single application to the uncovered albino rabbit skin.
Executive summary:

In a dermal irritation / corrosivity study using experimental methods described in an earlier publication (Smyth et al, 1962), 0.01 mL 4-vinylcyclohexene was applied, undiluted, to rabbit skin and left uncovered for 24 hours.

Irritation was ranked grade 4 (on the authors 1-10 scale, where grade 6 indicated necrosis when undiluted) following a single application to the uncovered albino rabbit skin. This study indicates that 4 -vinylcyclohexene applied undiluted is no more than a moderate irritant to the skin.

Based on these findings 4 -vinylcyclohexene should not be classified under DSD or CLP.