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 April 9 to May 6, 1986.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines and performed according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (U.K.) Limited, Wyton, Huntingdon.
- Age at study initiation: approx. five to eight weeks old.
- Weight at study initiation: males 115 - 146 g; females 128 - 140 g.
- Fasting period before study: overnight immediately before dosing and and for approximately two hours after dosing.
- Housing: animals were housed in groups of up to five by sex in polypropylene cages with sawdust bedding.
- Diet: ad libitum, Rat and Mouse Expanded Diet No. 1 (Special Diet Services Limited, Hitham, Essex, U.K).
- Water: ad libitum, drinking water.
- Acclimation period: minimum five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22 °C
- Humidity: 45 - 60 %
- Air changes: approx. 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg bw (conc: 250 mg/ml).
No. of animals per sex per dose:
Eleven male and eleven female: two males and two females per dose per group in the range-finding study; 5 males and 5 females in the main study.
Details on study design:
RANGE FINDING
A preliminary study was performed using pre-selected dose levels to determine the highest of these dose levels that produced less than 50 % mortalities as follows: 200, 2000 and 5000 mg/kg bw corresponding to the concentrations of 10.0, 100.0 and 250.0 mg/kg, respectively.
Two males and two females per dose per group were used.

MAIN STUDY
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Mortalities and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on the day of dosing (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy and examination for any macroscopic abnormalities.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
All treated animals showed hunched posture, pilo-erection and decreased respiratory rate one hour after treatment. Hunched posture and pilo-erection were apparent in all animals at the four-hour observation and on day one.
Diarrhoea was noted in several animals four hours after treatment.
All animals recovered and appeared normal on day two and throughout the study period.
Body weight:
Normal bodyweight gains were recorded during the study period.
Gross pathology:
No abnormalities were seen at necropsy on day 14.

Any other information on results incl. tables

RANGE-FINDING STUDY

Dose level (mg/kg) Sex Deaths at day Total deaths
0 1 2 3 4 5
200 Male 0 0 0 0 0 0 0/4
Female 0 0 0 0 0 0
2000 Male 0 0 0 0 0 0 0/4
Female 0 0 0 0 0 0
5000 Male 0 0 0 0 0 0 0/4
Female 0 0 0 0 0 0

MAIN TEST

Dose level (mg/kg) Sex Deaths at day Total deaths
0 1 2 3 4 5 6 7 8 - 14
5000 Male 0 0 0 0 0 0 0 0 0 0/10
Female 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw.
Executive summary:

Method

The acute oral toxicity of the test compound in rats of both sexes was tested at the single concentration of 5000 mg/kg bw and observed over a period of 14 days.

Results

The LD50 is greater than 5000 mg/kg bw.