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:
From October 10 to October 31, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD test guideline No. 401 but not following GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

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

Test animals

Species:
rat
Strain:
other: Fü-Albino outbred stock Ibm:RORO (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biological Research Laboratories (BRL) CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: no data
- Weight at study initiation: M: 124.5-140 g ; F: 117-126 g
- Fasting period before study: overnight before treatment, animals were given food again 4 hours after application of the test compound.
- Housing: max 3 per cage
- Diet (e.g. ad libitum): KLIBA 25-343, complete rodent maintenance diet ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 30, 60, 120 and 240 minutes after application and then daily
- Weighing: immediately before treatment and on day 7 and 14.
- Necropsy of survivors performed: yes (CO2 asphyxia)
Statistics:
none

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
None
Body weight:
Normal weight gain
Gross pathology:
No pathological changes
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study performed according to OECD test Guideline No 401, groups of Fü-Albino outbred stock Ibm:RORO (SPF) rats (5/sex) were administered a single oral dose of 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs, behaviour and appearance and then necropsied for macroscopic observations. 5 control rats per sex received a standard suspension vehicle.

None of the animals died during the study. No clinical signs were noted and weight gain was within normal range. No signs of gross pathological change were found by necropsy.

Oral LD50Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint