Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Hsd Cpb: WU
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: no data
- Mean weight at study initiation: 192 g - 224 g (males) or 169 g - 190 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 (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% (v:v) aqueous tylose
Details on oral exposure:
- Application volume: 20 mL/kg bw

Doses:
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: several times on the day odf administration and subsequently at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
Statistics:
none (limit test)

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 2000 mg/kg bw.
Clinical signs:
No clinical signs were observed.
Body weight:
Body weight development was not affected.
Gross pathology:
No gross pathological findings were observed.
Other findings:
none

Applicant's summary and conclusion

Executive summary:

In the acute toxicity study performed 1996 according to OECD TG 423 the test substance was untoxic with a LD50 value > 2000 mg/kg bw in rats. The oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings in both sexes.