Registration Dossier

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: well performed GLP and OECD gudeline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar, Hoe: WISKf(SPF71)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG company breeding colony
- Age at study initiation: male ca. 7 weeks, female ca. 8 weeks
- Weight at study initiation: male mean 171 g, female mean 179 g
- Fasting period before study: ca. 16 h
- Housing: AC, plastic cages with softwood granules, 5 animals per cage
- Diet (e.g. ad libitum): Rattendiät Altromin 1324, ad libitum
- Water (e.g. ad libitum): botteled tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% starch mucilage
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 ml/kg bw.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.

Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily, once daily at weekend and holiday
- Frequency of weighing: once a week
- Necropsy of survivors performed: yes

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:
2000 mg/kg bw. male: 0 of 5
2000 mg/kg bw. female: 0 of 5
Clinical signs:
IRREGULAR RESPIRATION, FLANKS DRAWN IN, STILTED GAlT, UNCOORDINATED GAlT, SQUATTING POSTURE.

NO ABNORMALITIES DETECTED at day 3 and thereafter.
Body weight:
body weight gain was not impaired
Gross pathology:
no abnormal finding
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50: >2000 mg/kg bw.

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.
Executive summary:

Male and female Wistar-rats were subjected to test acute oral toxicity according to OECD guideline 401. The test substance was administered by gavage at a dose of 2000 mg/kg bw (20% suspension in 2% starch mucilage). No animal died during the 14 day observation period, resulting in a LD50 >2000 mg/kg bw.