Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 March 1989 to 13 April 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Fü-albino SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Males about 6 weeks, females 6 to 7 weeks.
- Weight at study initiation: Males 125.0 to 132.7 g, females 125.0 to 140.6 g.
- Fasting period before study: About 18 hours.
- Housing: Individually caged.
- Diet: NAFAG standard rat maintenance diet, ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 45 to 65 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard Suspending Vehicle (SSV)
Remarks:
1000 mL SSV contains 5 g sodium carboxy methyl cellulose (medium viscosity), 4 mL Tween 80, 5 mL benzylalcohol pro analysi, 9 g sodium-chloride pro analysi and distilled water.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weigth

DOSAGE PREPARATION: The test article was kept suspended in Standard Suspending Vehicle (SSV) using a homogeniser. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer.
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: 16 days
- Frequency of observations and weighing: Mortality was recorded continuously and body weight was recorded on days 0 (immediately before treatment), 2, 6, 9, 13 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Behaviour, vivacity, signs of injury, signs of sickness and abnormality were performed repeatedly on the treatment day and daily during the treatment-free observation period.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs were observed.
Body weight:
The body weight development of males and females took a normal course known for this species and age.
Gross pathology:
No autopsy findings were seen.

Any other information on results incl. tables

Table 1. Body weights

 Sex  Mean body weights in g (standard deviation)               
 n = 5  Day 0  Day 2  Day 6  Day 9  Day 13  Day 15
 Male  129.2 (2.8)  157.9 (4.2)  187.8 (6.2)  206.4 (8.1)  225.4 (9.2)  210.0 (9.1)
 Female  130.2 (6.2)  147.5 (7.3)  159.2 (9.8)  165.8 (8.0)  174.4 (8.9)  164.0 (9.8)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 in rats was determined to be > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was determined in a 16 -day limit test conducted according to OECD 401. Male and female Fü-albino SPF rats, 6 to 7 weeks old, were dosed with the test item at a nominal concentration 2000 mg/kg bodyweight in Standard Suspending Vehicle by oral gavage. The dose volume was 10 mL/kg. Rats were observed for mortality and clinical signs and body weight. The LD50 was determined to be > 2000 mg/kg bw. There were no effects in body weight development and no clinical signs or autopsy findings were recorded. This study is considered reliable without restriction (Klimisch 1).