1,4-bis[(vinyloxy)methyl]cyclohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only study summary available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

lower animal number, abraded and non abraded skin

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis[(vinyloxy)methyl]cyclohexane

EC Number:

413-370-7

EC Name:

1,4-bis[(vinyloxy)methyl]cyclohexane

Cas Number:

17351-75-6

Molecular formula:

C12 H20 O2

IUPAC Name:

(1r,4r)-1,4-bis[(ethenyloxy)methyl]cyclohexane; (1s,4s)-1,4-bis[(ethenyloxy)methyl]cyclohexane

Details on test material:

- Name of test material (as cited in study report): divinyl ether of 1,4 cyclohexane, dimethanol
- Physical state: liquid
- desity: 0,96 g/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CAMM Research (Wayne, NJ, USA)
- Weight at study initiation: 2,48 - 2,75 kg

- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18,3 -23.9 °C (65-75 °F)
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: mid-dorsal area
- Type of wrap if used: J&J gauze sponge, J&J Dermicel hypo-allergenic cloth tape

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations wer 1, 3, 6 h post application and once daily afterwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed

Clinical signs:

other: No substance related symptoms were observed.

Gross pathology:

No gross internal changes were observed

Other findings:

Skin on the test site appears slightly reddend and scaling was noted.

Applicant's summary and conclusion

Executive summary:

The dermal acute toxicity study is reliable with restriction mainly to sight diviations from the OECD Guideline 402. 3 male and female rabbits recieved a limit dose of 2000 mg/kg on abraded and non abraded dorsal skin. No mortality (LD50 > 2000 mg/kg) and no clinical symptoms were observed. Necropsy reveald no gross findings. Beyond this sight reddening and scaling were observed at application site.

Conclusion

Dimethanol divinyl 1,4-cyclohexane is practically non-toxic after skin contact.