Decane-1,10-diol

Endpoint summary

Description of key information

The acute toxicity of 1,10 -decanediol was evaluated by oral and dermal route. The oral and dermal LD50 of 1,10 -decanediol are higher than 10 000 and 2000 mg/kg bw respectively.

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:

January - February 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

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 Madderin AG, 4414 Fuellinsdorf / Switzerland
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: males = 157-232 g ; females = 154-226 g
- Fasting period before study:
- Housing: in groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): "air conditioned" room without details
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

A dilution of the test compound was prepared using a homogenizer and kept homogenous during treatment using a magnetic stirrer.
Volume d'administration : 10 ml/kg at 1000 mg/kg, 20 ml/kg at 5000 and 10 000 mg/kg.

Doses:

1000, 5000, 10000 mg/kg bw

No. of animals per sex per dose:

5M/5F

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : daily
- Freqency of weighing: at the day of administration, days 7, days 14 after administration
- Necropsy of survivors and spontaneous death performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mortality observed (20%)

Mortality:

No mortality was observed at 1000 and 5000 mg/kg.
2 males died at 10 000 mg/kg, on day 1 (24 hours after administration)

Clinical signs:

other: The main symptoms observed were: sedation, dyspnea, exophtalmos, curved body position, diarrhea and ruffled fur. Theses symptoms were more prononced in the higher dose groups.

Gross pathology:

No macroscopical organ changes were observed.

Other findings:

no

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days was estimated to be greater than 10 000 mg/kg.

Executive summary:

The test substance was administered orally to rats of both sexes at doses from 1000 to 10 000 mg/kg. No mortality was observed at 1000 and 5000 mg/kg bw in groups of 5 males and 5 females. However 2 males died at 10 000 mg/kg, 24 hours after the administration. The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days was estimated to be greater than 10 000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

The study is considered as reliable with a klimish score of 1.

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

Study period:

June-July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Hsd/Cpb:WU (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Gartenstraße 27
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 200-300 g with a body weight deviating by no more than ± 20% from the average body weight of the collective per gender
- Fasting period before study: no data
- Housing: conventional, individually in a type III Makrolon cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

The application volume was set at a dose of 2000 mg/kg for 5 cm²/kg body weight because the substance concentration should be as high as possible but the formulation should still be able to be properly applied. In addition, the preparation must also ensure good skin contact.
First of all, 2000 mg/kg body weight of the test substance was dermally administered to two male and two female animals each. As no lethality was observed within 48 hours, 2000 mg/kg body weight of the test substance was administered to another three male and three female animals each.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

About 24 hours before the dermal application of the test substance, approx. 10% of the body surface on the back area of the animals was mechanically dehaired.
The animals were examined for clinical symptoms 0.5, 1, 2, 3, 4, 5 and 6 hours after the application and once a day for the following 2 weeks. The skin in the application area was examined for substance-induced skin reactions. The temporal occurrence and the nature of the symptoms were logged separately for each animal. The body weight of the animals was measured on the application day (day 0), on day 7 and at the end of the experiment (day 14).
After the 14-day observation period, all the animals were killed by inhaling carbon dioxide, dissected and examined for macroscopically-visible organ changes. The necropsy results were recorded for each animal individually.

Statistics:

no

Preliminary study:

no

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the observation period (14 days).

Clinical signs:

other: The male nor female animals exhibited any poisoning symptoms or skin reactions in the application area during the observation period.

Gross pathology:

Necropsies at the end of the experiment did not reveal any evidence of substance-induced macroscopically-visible organ changes in any of the animals. In particular, no changes appeared on the skin or the subcutaneous tissue in the application area.

Other findings:

no

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal toxicity study of 1,10 -decandiol in rats revealed the following median lethal dose (LD50) in the limit test is higher than 2000 mg/kg bw for males and females.

Executive summary:

The acute dermal toxicity study in rats of 1,10-DECANDIOL revealed that the solid test substance, formulated in corn oil MEH 56, did not result in any substance-induced lethality in the limit test with a dose of 2000 mg/kg body weight administered to five male and five female animals. No symptoms of systemic poisoning or skin changes in the form of erythema or oedema were observed in the application area during the observation period. The test substance was applied dermally for an exposure time of 24 hours (semi-occlusive dressing). A volume of 20 ml/kg body weight was applied. The development of body weight was normal for all the animals.

The necropsies at the end of the experiment did not show any indications of substance-induced, macroscopically-visible organ changes or changes in the subcutaneous tissue or application area.

The dermal toxicity study of 1,10 -decandiol in rats revealed the following median lethal dose (LD50) in the limit test is higher than 2000 mg/kg bw for males and females.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The key study is considered to be reliable with a klimish score of 1.

Additional information

Acute oral study (Ullman 1982):

The test substance was administered orally to rats of both sexes at doses from 1000 to 10 000 mg/kg. No mortality was observed at 1000 and 5000 mg/kg bw in groups of 5 males and 5 females. However 2 males died at 10 000 mg/kg, 24 hours after the administration. The acute oral LD50 of the test substance in rats of both sexes observed over a period of 14 days was estimated to be greater than 10 000 mg/kg.

Acute dermal study (Eisele 1995):

The acute dermal toxicity study in rats of 1,10 -decanediol revealed that the solid test substance, formulated in corn oil MEH 56, did not result in any substance-induced lethality in the limit test with a dose of 2000 mg/kg body weight administered to five male and five female animals. No symptoms of systemic poisoning or skin changes in the form of erythema or oedema were observed in the application area during the observation period. The test substance was applied dermally for an exposure time of 24 hours (semi-occlusive dressing). A volume of 20 ml/kg body weight was applied. The development of body weight was normal for all the animals.

The necropsies at the end of the experiment did not show any indications of substance-induced, macroscopically-visible organ changes or changes in the subcutaneous tissue or application area.

The dermal toxicity study of 1,10 -decandiol in rats revealed the following median lethal dose (LD50) in the limit test is higher than 2000 mg/kg bw for males and females.

Justification for classification or non-classification

Based on the available data, 1,10 -decanediol is not classified for acute toxicity according to the Regulation EC n°1272/2008.