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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:
key study
Study period:
January 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
The test material was a 47% aqueous solution of the substance

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: m: 125 - 135g; f: 110 - 125g
- Fasting period before study: over night
- Housing: single caging, cage type: Macrolon type IlI./max. 5
- Diet: ad libitum; rat diet (R 4 Alleindiät für Ratten), Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

The test substance was weighed out in a glass, then was filled with Aqua destillata up to the desired volume, was shaken well and afterwards labeled. The formulated test substance was a clear solution.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The group of 5 female and 5 male rats were were given a single oral dose 5000 mg/kg of the test substance by gavage.

- Duration of observation period following administration: 14 d
- Body weights were recorded before treatment (day -1), at the treatment day (day 0), and on days 7 and 14 after treatment
- Clinical observation: Animals were observed 1/4 h, 1/2 h, 1 h, 2 h, 4 h after dosing and thereafter once daily up to day 14.
- Necropsy of the survivors performed: yes
Statistics:
As none of the test animals died a calculation of the LD50 was not possible.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: based on product; mortality 0/10
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 350 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: based on a.i.; mortality 0/10
Mortality:
There were no mortalities
Clinical signs:
Except of ruffled fur on the day of treatment, the animals were free of clinical-/toxicological symptoms during the entire observation period of 14 days.
Body weight:
Body weight changes during the observation period showed a normal weight gain.
Gross pathology:
Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the test material was >5000 mg/kg bw (47% a.i.), equivalent to LD50 > 2350 mg/kg bw (100% a.i.)
Executive summary:

In an acute oral toxicity study similar to OECD Guideline 401 (1981) 5 male and 5 female Sprague-Dawley rats were given a single dose of the substance (a.i. 47 %) at a dose of 5000 mg/kg bw (limit test). The test item was formulated in water and applied in a volume of 10 mL/kg bw. Animals were subsequently observed for 14 consecutive days.There were no deaths following a single oral dose of the substance. Except of ruffled fur on the day of treatment, the animals were free of clinical/ toxicological signs during the entire observation period of 14 days. Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Oral LD50Combined: > 2350 mg/kg bw (active ingredient)

LD50 > 5000 mg/kg bw determined in the study report refers to the test substance as delivered by the sponsor. Amount of active ingredient in test substance is 47 % according to the sponsor information. Therefore the calculated oral LD50 combined referring to 100 % active substance is 2350 mg/kg bw. The substance is practically nontoxic based on LD50 in males and females.