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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in accordance to GLP. However, purity of test article is unknown.

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)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: commercial grade
- Lot/batch No.: OP. 11006
- Expiration date of the lot/batch: 1995-12-31
- Stability of test article: stable
- Stability of test article diluion: at least 2 h

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain of animals as stated in the report: KFM-Han. Wistar (outbred, SPF-Quality)
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 214 - 237 g (males), 172 - 200 g (females)
- Housing: groups of 5 in Makrolon type-3 cages
- Diet: pelleted standard Kliba 343, rat maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 +/-3
- Humidity (%):40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
The test article was suspended in the vehicle (weight by volume). Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.

MAXIMUM DOSE VOLUME APPLIED: no data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals (5 females, 5 males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations on mortality and viability and clinical signs: 4-times during test day 1, daily during days 2 - 15
- Frequency of weighing: body weight was assessed on day 1, 8 and 15.
- Necropsy of survivors performed: yes, all animals were sacrifieced and subjected to gross pathology.
Statistics:
No statistics were performed.

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:
other: None of the animals died after treatment.
Mortality:
No mortality occured.
Clinical signs:
After administration of 5000 mg/kg bw sedation, dyspnea, hunched body position and ruffled fur were observed in animals of both sexes. Additionally rales were observed in males. All rats recovered after 24 h. In addition to the above symptoms the extremities of all animals were reddish discolored after 24 h, which was not observed on the following days.
The observed symptoms were equal in intensity and duration among the animals.
Body weight:
No abnormal body weight changes were observed. Mean values are given below.

Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
No other findings

Any other information on results incl. tables

Table 1 Mean body weights in grams (Dose level: 5000 mg/kg bw)

Test day

1 *

8

15

 

 

 

 

Male

224 +/- 8.5

264 +/- 10

289 +/- 12

Female

187 +/- 11

211 +/- 11

217 +/- 12

* body weights on day 1 were assessed before application of 5000 mg/kg bw.

Applicant's summary and conclusion