Dodecane-1,12-diol

Endpoint summary

Description of key information

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.

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

Study period:

Jan. - Feb. 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Quality of whole database:

only one study available

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study for oral toxicity (OECD 401) classification according to EU Regulation 1272/2008 is not required.