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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: experimental study on similar substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant with certificate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Charles River Wiga Gmbh Deutschland, Sulzfeld
- Weight at study initiation: The weights of the male rats are: 461,2 g ± 23,3 g. The weights of the female rats are: 275,2 g ± 11 g.
- Fasting period before study: 22 h
- Housing: 3 animals per cage Type 3 Makrolon
- Diet: Altromin 1326 ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20,5 - 22,5
- Humidity (%): 25-40
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark










Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
600
Doses:
Single dose: 2000 mg/kg
No. of animals per sex per dose:
6 male and 6 female
Control animals:
yes
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality
Clinical signs:
Diarrhoea occurred in 3 male rats 5 hours after exposure to the test substance.
Discoloration of the faeces occurred 5 day after the exposure.

Body weight:
There was an increase of weight in each animal, both for males and females.
Gross pathology:
No damage to any organs.
Other findings:
The exposure to the tested substance did not influencing the behaviour of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non toxic for oral exposure with a LD50 > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity was assessed following the OECD 401.

The results show no toxicity with a LD value > 2000 mg/kg.