Dodecane-1,12-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. - Feb. 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecane-1,12-diol

EC Number:

227-133-9

EC Name:

Dodecane-1,12-diol

Cas Number:

5675-51-4

Molecular formula:

C12H26O2

IUPAC Name:

dodecane-1,12-diol

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf/Switzerland
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 168-241 g (males); 156 - 242 g (females)
- Housing: Caged in groups of five in macrolon cages type 3
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Volume/ kg bw:
10 ml (1000 mg/kg dose group)
20 ml (5000 mg/kg dose group)
20 ml (10000 mg/kg dose group)

Doses:

1000, 5000 or 10000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observations were performed before and 1, 2 as well as 3, 5 and 24 hours after administration. All animals were observed for a period of 14 days.
During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The time of death would have been recorded as precisely as possible. Individual body weights were recorded before administration of the test item and thereafter days 7 and 14 after the administration. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.,

Statistics:

No statistical analysis could be performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

other: Treatment resulted in reversible clinical symptoms in all dose groups. No clinical signs were observed from test day 10 until the end of the study.

Gross pathology:

no findings

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The acute oral LD50 in rats is determined with >10000 mg/kg bw based on the results of a study performed according to OECD TG 401. No deaths occurred. The test doses up to and including 1000 mg/kg bw resulted in reversible clinical signs. No clinical signs were observed from test day 10 until the end of the study. All animals gained the expected body weight and no gross pathological findings were recorded.