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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: PFA-SD (IOPS Caw)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA- Credo
- Age at study initiation: 5 weeks
- Weight at study initiation: 136 to 161 g- male; 119-131 g-emales
- Fasting period before study: 18 hours
- Housing: 2 to 3 per same group in stainless steel cage
- Diet (e.g. ad libitum): UAR AO4C
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2 C
- Humidity (%): 40-70 %
- Air changes (per hr): 10 to 11
- Photoperiod (hrs dark / hrs light):12/24

IN-LIFE DATES: From: Feb 17th, 1994 To:March 4, 1994

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.6 % methyl cellulose aqueous solution
Details on oral exposure:
Using all available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
dose level: 0, 1000, 2000 mg/kg male; 0, 2000 female
concentration: 10 ml/kg
Doses:
dose level: 0, 1000, 2000 mg/kg male; 0, 2000 female
No. of animals per sex per dose:
5 females/males per dose.
Control animals:
yes
Details on study design:
The animals were observed for deaths or overt signs of toxicity for fifteen days. All animals were subjected to macroscopic pathological observations. Body weights were recorded on days D1,D3,D8 and D15.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 1 000 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were 2 deaths. time of death after dosing
one animal: mortality occurred within 24 hours following treatment
Clinical signs:
Signs of systemic toxicity noted:
>=1000 mg/kg- pytalism, decubitus on D1 ( males only 5/5)
>= 2000 mg/kg - prostration, piloerection on D1( 5M/5, 5F/5)
piloerection and urogenital area on D2 ( 2M/2, 5F/5)
Body weight:
Bodyweight gain slightly decreased on D3 ( with total recovery on D8 in females and D15 in males)
Gross pathology:
at 2000: l
ungs - dark red (3/3); non-collapsed (2/3)
stomach - hemorrhagic contents (2/3)
spleen: pales (1/3)
soiled urogenital area ( 2/3)

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material was greater than 2000 mg/kg bodyweight for females and approximately 2000 mg/kg males.