2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: PFA-SD (IOPS Caw)

Sex:

male/female

Details on test animals or test system 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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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:

other: 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)

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.