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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
fixed dose procedure

Test animals

Species:
other: Rat, (Sprague-Dawley)

Administration / exposure

Vehicle:
other: The test material was used as supplied.
No. of animals per sex per dose:
Preliminary sighting study: 1 (female)
Main study: 5 (female)
Details on study design:
Preliminary sighting study:
At the request of the sponsor, 5000 mg/kg was chosen as the
starting dose.

Main study:
In the absence of toxicity at a dose level of 5000 mg/kg, an
additional group of animals was treated at the same dose
level.

Results and discussion

Preliminary study:
Species/strain: Rat, (Sprague-Dawley)
5000 mg/kg bw: Evident toxicity: N; Mortality: N

Observations:
Mortality:

There were no deaths.



Clinical observations:

No signs of systemic toxicity were noted.


Bodyweight:

The animal showed expected gain in bodyweight over the
study period.


Necropsy:

No abnormalities were noted at necropsy.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Dose descriptor:
other: 5000 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5
Clinical signs:
Signs of toxicity:
Mortality:

There were no deaths.
Gross pathology:
Effects on organs:
Necropsy:

No abnormalities were noted at necropsy.
Other findings:
Clinical observations:

No signs of systemic toxicity were noted.


Bodyweight:

All animals showed expected gains in bodyweight over the
study period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information