Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 8, 1992 - May 26, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
OECD 1981, updated Guideline adopted February 24, 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Batch: E631441

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 180 g (169 - 194 g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 28°C
- Humidity (%): 43-58%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
Methocel K4M Premium solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.

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:
All rats survived the observation period.
Clinical signs:
Retention of feces was observed in two female rats on day 2 of the study. No other signs of intoxication were observed after treatment.
Body weight:
Body weight development of treated rats was normal.
Gross pathology:
In the rats, which were all sacrified at the end of the observation period, no organ alterations were seen.

Any other information on results incl. tables

Study design

The test material was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401.

Results

The investigation was performed as limit test (2000 mg/kg). Retention of feces was observed in two female rats on day 2 of the study. No other signs of intoxication and no mortality were observed after treatment. There was no need for a LD50 determination.

Conclusion

For regulatory purposes, the median lethal dose (LD50) for males and females, after an observation period of 15 days, may be listed as >2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.
Executive summary:

This study was performed according to GLP and is fully compliant OECD TG 401. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.