Registration Dossier

Administrative data

Description of key information

Dimethanol-1,4-cyclohexane divinylether is of low toxicity after single ingestion and short term skin contact.
LD50
oral (rat): > 5000 mg/kg
dermal (rabbit): > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Camm Research (Wayne; NJ USA)
- Weight at study initiation: 190-220 g
- Fasting period before study: 18 h
- 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 (65-75 °F)
- Photoperiod (hrs dark / hrs light): 12h
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were 1, 3 and 6 h post application, once daily there after. Weighing was prior to application and at termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
none
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
4 of 10 animals died.
day 0 -1: no death occurred
day 2: one male
day 3: one male; one female
day 4: one female
day 5 -14: no death occurred
Clinical signs:
Slight to severe depression of activity was noted for 5 animals. One animal appeard dehydrated on the second and the third day. Muscle tremor was noted for two animals on the second day.
Body weight:
Body weight development in the surviving animals was positive. Body weight of animals found dead was reduced in comparison to the beginning of the study.
Gross pathology:
No pathological changes were observed at necropsy of the surviving animals. Gastrointtestinal irritation and motteld to bleached liver lobes was observed in the animals found dead.
Executive summary:

Oral toxicity was examined in a guidline study similar to OECD 401. The study is reliable with some minor restriction mainly due to poor documentation of the test substance. Male and female Wistar rats recieved a limit dose of 5000 mg/kg. 4 (2 m/2f) animals died. The LD 50 therfore is > 5000 mg/kg. Gastrointestinal irritation and mottled liver lobes were observed at necropsy.

Conclusion

Dimethanol-divinyl ether of 1,4- cyclohexane is practically non-toxicic after swallowing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral toxicity was examined in a guideline study similar to OECD 401 (val 2). Five Male and female Wistar rats recieved a limit dose of 5000 mg/kg . 4/10 (2 m/2f) animals died. The LD 50 was determined to be > 5000 mg/kg. Gastrointestinal irritation and mottled liver lobes were observed at necropsy of animals that died. There were no gross findings in animals that survived.

The acute dermal toxicity was examined in a study similar to OECD Guideline 402 (Val 2). 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, slight reddening and scaling were observed at application site.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Classification for acute toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.