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Toxicological information

Acute Toxicity: oral

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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:
Nov 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: not specified
- Mean weight at study initiation: 193-211 g (males) or 180-195 g (females)
- Housing: in groups of 5 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): approx. 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: test item was suspended in 15 % Pluronic F68 (42.5 % propylene glycol and 42.5 % polyethylene glycol 400)
Details on oral exposure:
- Application volume: 10 mL/kg bw

Doses:
500 and 2000 mg/kg
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 and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died after administration of 500 or 2000 mg/kg bw.
Clinical signs:
After administration of 500 and 2000 mg/kg bw soft feces were observed in all animals up to day 3 of the observation period.
Body weight:
Body weight development was not affected.
Gross pathology:
No gross pathological findings were observed.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

The acute oral toxicity of the test item BAY 54-9085 was low with an LD50 exceeding 2000 mg/kg bw in rats according to OECD TG 401. A single oral administration of the test substance by gavage to male and female rats in doses up to 2000 mg/kg bw was tolerated without mortalities, effects on body weight gain or gross pathological findings. After administration of 500 or 2000 mg/kg bw soft feces was observed in both genders.