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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
source of read across
Adequacy of study:
key study
Study period:
From 3rd to 29th March, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
For the purpose of this study the test material was ground to a fine powder using a mortar and pestle freshly prepared.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire.
- Age at study initiation: at the start of the main study the males weighed 174 - 192 and the females 150 - 161 gg
- Weight at study initiation: at the start of the main study the rats were approximately five to eight weeks old.
- Fasting period before study: over-night fast immediately before dosing and for approximately two hours after dosing.
- Housing: the animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K, ad libitum.
- Water: drinking water, ad libitum.
- Acclimation period: minimum five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 22 °C
- Humidity: 39 - 45 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
RANGE-FINDING
The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Vehicle: distilled water.
Cocnentration: 200 and 500 mg/ml.
Dose volume: 10 ml/kg

MAIN TEST
Vehicle: distilled water.
Cocnentration: 500 mg/ml.
Dose volume: 10 ml/kg
Doses:
RANGE-FINDING: 2000 and 5000 mg/kg bw
MAIN TEST: 5000 mg/kg bw
No. of animals per sex per dose:
RANGE-FINDING: 1 male and 1 female per group.
MAIN TEST: 5 male and 5 female per group.
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 a mortality rate of less than 50 % as follows.
One male and one female were dosed at 5000 mg/l and another one male and one female were desed at 2000 mg/kg.
Animals were observed 1 and 4 hours following dosing‘and then once daily for five days. Deaths and evidence of overt toxicity were recorded at each observation. No necropsies were performed.

MAIN TEST
- 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. Deaths 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: all animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 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:
All treated animals appeared normal during the study period.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were detected at necropsy of animals kilied at the end of the study.

Any other information on results incl. tables

Individual bodyweights and weekly bodiweight increases in the main study

Dose level (mg/kg) Animal number and sex Bodyweight (g) at day Increment (g) during week
0 7 14 1 2
5000 3-0 M 179 254 312 75 58
3-1 M 174 262 326 88 64
3-2 M 192 286 356 94 70
3-3 M 176 260 323 84 63
3-4 M 177 244 292 67 48
4-0 F 152 198 220 46 22
4-1 F 161 197 222 36 25
4-2 F 154 190 214 36 24
4-3 F 151 193 220 42 27
4-4 F 150 190 216 40 26

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Ragulation (EC) No 1272/2008
Conclusions:
LD50 > 5000 mg/kg bw (males and females)
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley rat. The method followed the OECD Guidelines 401 (1981). A preliminary study was performed unsing pre-selceted doses of 2000 amd 5000 mg/kg bw; the highest of the two doses that produce a mortality rate of less than 50 % was selected for the main test.

In the main experiment, a group of five males and five females was treated with 5000 mg/kg bodyweight. The test material was administered orally by gavage.

No deaths occurred and no signs of systemic toxicity were noted during the study.

Conclusion

LD50 > 5000 mg/kg bw (males and females)