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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.