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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Principles of method if other than guideline:
Groups of four Sprague-Dawley rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered by gavage. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
GLP compliance:
no
Remarks:
pre GLP
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
- Weight at study initiation: from 150 to 227 grams.
- Housing: following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages.
- Fasting period before study: 16 hours period immediately prior to oral intubation.
- Diet: standard laboratory diet, ad libitum.
- Water: ad libitum.
- Acclimation period: all animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
The test material was administered as a 50. 0 percent (w/v) aqueous suspension.
Doses:
4600, 6800, 10200, 15400 mg/kg
No. of animals per sex per dose:
2 males and 2 females
Details on study design:
- Duration of observation period following administration: 14 days.
- Observations and weighing: initial and final body weights as well as all mortalities and/or reactions displayed were recorded.
- Necropsy of survivors performed: necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.
Statistics:
At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil, Thompson, and Thompson and Weil.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Standard Deviation of LD50 = ± 1200 mg/kg
Mortality:
No death occurred at 4600 and 6800 mg/kg. At 10200 2 oput of 4 rats died, while at 15400 mg/kg no rat survived.
Clinical signs:
Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses.
At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.
Gross pathology:
Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.

Any other information on results incl. tables

Mortality and Body Weight Data

Dose (mg/kg) Animal N. and sex Individual body weight (g) Number Dead/Number Tested Percent
Dead
Test day N.
0 14
4600 1M 184 242 0/4 0
2M 160 244
3F 174 194
4F 172 177
6800 5M 182 250 0/4 0
6M 177 250
7F 158 192
8F 158 167
10200 9M 178 (6-22 hrs) 2/4 50
10M 205 268
11F 156 (6-22 hrs)
12F 150 178
15400 13M 160 (6-22 hrs)

4/4

100

14M

189

(6-22 hrs)

15F

163

(6-22 hrs)

16F

184

(6-22 hrs)

Summary of Reactions

Dose (mg/kg) Reaction Time of onset after dose administration Duration of reaction
4600 Hypoactivity 1 hour 2 days
Ruffed fur 6 - 2 2 hours 1 day
6800 Hypoactivity 1 hour 3 days
Ruffed fur 5 hours 3 days
Muscular weakness 5 hours 1 day
10200 Hypoactivity 1 hour 3 days
Ruffed fur 1 hour 3 days
Muscular weakness 3 hours 2 days
15400 Hypoactivity 1 hour Until death
Ruffed fur 1 hour Until death
Muscular weakness 1 hour Until death
Prostration 5 hours Until death

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50: 10200 mg/Kg bw.
Executive summary:

Method

Young albino rats of the Sprague-Dawley strain were used in order to assess the cute toxicity potential by otral route of the test item. Selected groups of four rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.

Results

No death occurred at 4600 and 6800 mg/kg; at 10200 mg/kg 2 out of 4 rats died, while at 15400 mg/kg no rat survived.

Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.

Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.