Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2006-11-16 to 2006-12-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study OECD 420, with deviation. The purity of the test substance is not mentioned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
purity of test substance not mentioned
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fluowet I 800 solid
- Molecular formula (if other than submission substance): n/a
- Molecular weight (if other than submission substance): n/a
- Physical state: red brown solid block + liquid
- Analytical purity: n/a
- Composition of test material, percentage of components: n/a
- Lot/batch No.: DEGB017722
- Expiration date of the lot/batch: n/a
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
300 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
1 female at 300 mg/kg bw first, followed by 5 females at 2000 mg/kg bw.
Control animals:
no
Details on study design:
All animals were dosed once only by oral gavage, using a metal cannula. Treatment of animals was sequential. Volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for forteen days. Individual bodyweights were recorded on day 0 (the day of dosing) and on days 7 and 14. At the end of exposure period animals were killed by cervical dislocation. All animals were subjected to gross necropsy.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: none
Mortality:
There were no deaths
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female rat was estimated to be greater than 2000 mg/kg body weight.
Executive summary:

The acute oral median lethal dose (LD50) of the test material in the female rat was estimated to be greater than 2000 mg/kg body weight.