Decane-1,10-diol

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Decane-1,10-diol

EC Number:

203-975-2

EC Name:

Decane-1,10-diol

Cas Number:

112-47-0

Molecular formula:

C10H22O2

IUPAC Name:

decane-1,10-diol

Test animals

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:

Administration / exposure

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

Results and discussion

Preliminary study:

no

Effect levels

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

Applicant's summary and conclusion

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.