Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (e.g. only 7 days post observation period, no details on body weight development)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(only 7 days of observation p.a.; details on body weight development are missing)
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF in house breeding colony
- Weight at study initiation: 130 - 170 g
- Fasting period before study: 16 h
- Diet: Standard-ALTROMIN R, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % suspension in sesame oil


Doses:
15 000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Other findings:
Test substance was excreted via the faeces.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 7 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Executive summary:

Female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest dose levels applicable: 15000 mg/kg bw. No animal died under these conditions during the 7 day observation period, thus leading to a LD50 > 15000 mg/kg bw.