4,7-Decanediol, 2,4,7,9-tetramethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25. September 2001 - 15. October 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2,4,7,9-tetramethyldecane-4,7-diol

EC Number:

451-160-7

Cas Number:

17913-76-7

Molecular formula:

C14H30O2

IUPAC Name:

2,4,7,9-tetramethyldecane-4,7-diol

Details on test material:

Analytical purity: 99 %
Lot #18197-D-5

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg single dose at 0 h

No. of animals per sex per dose:

3 male and
3 female

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

All animals survived the 2000 mg/kg oral dose.

Bodyweight changes were normal.

Instances of dyspnea, anogenital area wet, chromorhinorrhea and localized alopecia were noted during the observation period.

Necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of 2,4,7,9-tetramethyldecane-4,7-diol is >/=2000 mg/kg bw.

Executive summary:

The oral LD50 value of 2,4,7,9-tetramethyldecane-4,7-diol in rats is greater than 2000 mg/kg body weight. Three healthy male and three healthy female Wistar albino rats were dosed orally with 2,4,7,9-tetramethyldecane-4,7-diol at 2000 mg/kg. The rats were observed 1, 2, 3, and 4 hours post-dose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors. All animals were examined for gross pathology. The test article was assigned to be a toxic class based on the mortality response noted. All animals survived the 2000 mg/kg oral dose. Body weight changes were normal. Instances of dyspnea, anogenital area wet, red nasal discharge, and localized alopecia were noted during the observation period. Necropsy results were normal.