Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1955
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles. For some data limited details were available, however the study is relevant, adequate and reliable for classification.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7 days observation instead of 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: Not provided
- Fasting period before study: Not provided
- Housing: By groups
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not provided

ENVIRONMENTAL CONDITIONS: Not provided


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
10.0, 14.7, 21.5 and 31.6 mL/kg bw . The material as received was reported to contain 35% active ingredient.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration:7 days
- Frequency of observations and weighing: Not provided
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Statistics:
Thompson moving average method

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
18.7 mL/kg bw
Based on:
test mat.
Remarks on result:
other: confidence limits from 13.7 to 25.6 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 6.6 mL/kg bw
Based on:
act. ingr.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 6 500 mg/kg bw
Based on:
other: solids content
Remarks on result:
other: confidence limits from 4.8-9.0 g/kg bw
Mortality:
In the 1.0 mL/kg bw dose group 1/5 animals died, in the 14.7 mL/kg dose group 1/5 animals died, in the 21.5 mL/kg dose group 3/5 animals died and in the 31.6 mL/kg dose group 5/5 animals died.
Clinical signs:
Following oral administration of [Trade name], the rats at all dosage levels appeared depressed and exhibited labored respiration and a watery diarrhea. The surviving animals continued to exhibit these signs for 24 or 48 hours following oral administration. Thereafter, the survivors at the two lower dosage levels appeared normal, while those at the 21.5 mL/kg level appeared slightly depressed through the fifth day following dosage.
Body weight:
Not provided
Gross pathology:
Gross autopsies performed upon the animals that died showed the following significant gross pathology: hyperemic lungs, irritation of the gastrointestinal tract, and congested kidneys and adrenals. Gross autopsies performed upon the surviving animals at the end of the observation period showed no significant pathology.
Other findings:
Not provided

Any other information on results incl. tables

Table 1. Acute toxicity of [Trade name] following oral administration of the undiluted material to male albino rats. Values are number of animals dead/number of animals tested, cumulative.

 

Dose (mL/kg)

Time of death (days)

1

2

3

4

5

6

7

10.0

0/5

1/5

1/5

1/5

1/5

1/5

1/5

14.7

0/5

0/5

0/5

1/5

1/5

1/5

1/5

21.5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

31.6

3/5

4/5

4/5

5/5

 

 

 

LD50 (mL/kg) = 18.7

Confidence limits (mL/kg) = 13.7-25.6

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be a practically non-toxic material by ingestion in single doses. The acute LD50 of undiluted test item for male albino rats, calculated by the Thompson moving average method, is 18.7 mL/kg of body weight, with confidence limits from 13.7 to 25.6 mL/kg. Based on a concentration of 35% active ingredient, the acute oral LD50 would be approximately 6.6 mL/kg, corresponding to ca. 6500 mg act.ingr./kg bw.
Executive summary:

Groups of five male albino rats each were administered orally by stomach tube the undiluted test item containing 35.8% active ingredient at dosage levels of 10.0, 14.7, 21.5, or 31.6 mL/kg of body weight. Rats at all dosage levels appeared depressed and exhibited labored respiration and a watery diarrhea. The surviving animals continued to exhibit these signs for 24 or 48 hours following oral administration. Thereafter, the survivors at the two lower dosage levels appeared normal, while those at the 21.5 m L/kg level appeared slightly depressed through the fifth day following dosage.
Gross autopsies performed upon the animals that died showed hyperemic lungs, irritation of the gastrointestinal tract, and congested kidneys and adrenals. Surviving animals at the end of the observation period showed no significant pathology.
The acute LD50 of undiluted test item for male albino rats was ca. 6500 mg act.ingr./kg bw.