Reaction mass of 4-vinylcyclohexene, cyclohexane and n-hexane

Skin irritation / corrosion

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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.