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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:
November 23rd 1998 - December 9th 1998.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: They follow OECD methods and were conducted in accordance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
White powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation:male: 220-225 grams; females 204-213 g
- Fasting period before study: yes
- Housing: solid floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-21 C
- Humidity (%): 44-66%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: November 23, 1998 To:December 9, 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?): observed for dealth or overt signs of toxicity at 1/2 ,1 ,2 and 4 hours after dosing and then once a day for 14 days
- Frequency of observations and weighing: individual bodyweights were recorded prioir to dosing and then at day 7 and day 14 after treatment
- Necropsy of survivors performed: yes- gross pahtological changes - macroscopic observation, no tissues were retained.
- Number of animals dying were recorded

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
None noted
Clinical signs:
none noted
Body weight:
all animlals gained expected bodyweight over length of study
Gross pathology:
NOne noted

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material, Sch.56592-U, in the Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.
Executive summary:

The acute oral median lethal dose (LD50) of the test material, Sch.56592-U, in the Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight.