Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study

Data source

Reference
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
> 98%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Rat, Wistar strain Crl:(WI) BR (outbred, SPF Quality).
Recognised by international gUidelines as the
recommended test system (e.g. OECD, EEC).
Source: Charles River, Germany.
Approx. 11 week of age
Within ~ 20% of the sex mean body weight
5 males and 5 females
Identification: Earmark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Food was withheld overnight prior to dosing until
approximately 3-4 hours after administration of the test
substance.
Doses:
2000 mg/kg bw in 10 mL of destilled water
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes
Details on study design:
At periodic intervals on the day of dosing (day 1) and
once daily thereafter, until day 15. The time of onset,
degree and duration were recorded.
All animals surviving to the end of the observation
period (day 15) were sacrificed by oxygen/carbon dioxide
asphyxiation. All animals assigned to the study were
subjected to necropsy and descriptions of all macroscopic
abnormalities recorded.

Results and discussion

Preliminary study:
none
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
No animals died during the study.
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs of toxicity were observed during the study.
Body weight:
The body weight gain shown by the animals over the study period was considered
to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of BETA W 7 A 1.0 in rats was established as exceeding 2000 mg/kg body weight.
Executive summary:

Assessment of acute oral toxicity with BETA W 7 A 1.0 in the rat.

The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 92/69/EEC, Part B.1, "Acute Toxicity-Oral". BETA W 7 A 1.0 was administered by oral gavage to five rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period (day 15). No mortality occurred and no clinical signs of toxicity were observed during the

study period. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination.

The oral LD50 value of BETA W 7 A 1.0 in rats was established as exceeding 2000 mg/kg body weight.