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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 423.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
Lot No. 0024
Storage: Room Temperature in the dark.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females per group
Control animals:
not specified

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Remarks on result:
other: The LD50 was determined from a top dose of 2000 mg/kg BW according to OECD Guideline 423.
Mortality:
No deaths and no signs of systemic toxicity occured. At necropsy no abnormalities were noted.
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweights over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (td50) of the test material in the female Sprague Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.