Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 25, 1997 - February 11, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
92/69/EEC Part B
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Hsd:Sprague Dawley® SD®
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Indianapolis, Indiana
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 212 to 273 g
- Fasting period before study: overnight.
- Housing: individually in hanging stainless steel cage
- Diet: Certified Rodent Chow ad libitum
- Water: tap water ad libitum
- Acclimation period: 8 days before

ENVIRONMENTAL CONDITIONS
- Temperature: 69 - 70°F
- Humidity : Ambient
- Photoperiod :12hrs light/12rhs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.2% Hydroxypropyl methyl cellulose
Details on oral exposure:
Since the test material was found to be relatively non toxic at the limit dose of 2000mg/kgBW, additional doses were not administered to rats in this study.
dose level: 2000 mg/kg
concentration: 10 ml/kg
Doses:
Single dose: 2g/kgBW at a dose level of 10ml/kgBW
No. of animals per sex per dose:
5 females/males per dose
Control animals:
no
Details on study design:
All animals were observed frequently on day of dosing and daily thereafter for at least 13 days after treatment for a total of 14 days. Day of treatment = day 0.
Daily observations included signs of toxicity in addition to lethality.
Animals weighed on a weekly basis.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was 0 (zero) mortality
Clinical signs:
Soft stool and/or diarrhoea was observed in all rats following treatment. These signs were confined to the day of treatment.
Body weight:
No apparent body weight changes were observed during week one or two of the observation period following treatment.
Gross pathology:
No gross morphological changes were noted in rats that were euthanized and necropsied at the end of the two week observation period following treatment.

Applicant's summary and conclusion

Conclusions:
LD50 was greater than the limit dose of 2000mg/kgBW