Registration Dossier

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:
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

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
- Physical state: liquid
- desity: 0,96 g/ml

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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:
No substance related symptoms were observed.
Body weight:
Body weight development was positive
day 0: 2,65 +/- 0,097 kg
day 14: 2,82 +/- 0,216 kg
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.