Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females: 11 weeks
- Weight at study initiation: males: 188 - 197 g, females: 170 - 182 g
- Fasting period before study: 12 to 18 hours
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, rat maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period:

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Application Volume / kg body weight: 10 ml at 2000 mg/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: 2000 mg/kg: males - breathing: rales (1), males - no clinical signs (4) females - no clinical signs (5)
Gross pathology:
2000 mg/kg:

dead: lungs: discoloration, pale (1)

sacrificed: lungs: discoloration, dark red (1)
no macroscopical organ changes (8)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw
The test item is not subject to classification and labelling.
Executive summary:

In accordance with OECD TG 401 the test article was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg.

DEATH RATE:

10% at 2000 mg/kg (i.e. 1/10).

CLINICAL SIGNS:

males:

- breathing: rales (1)

- no clinical signs (4)

females

- no clinical signs (5)

The male animal had recovered after 2 observation days.

BODY WEIGHTS:

The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.

MACROSCOPICAL FINDINGS:

dead:

- lungs: discoloration, pale (1)

sacrificed:

- lungs: discoloration, dark red (1)

- no macroscopical organ changes were observed (8)