N-(cyclohexylthio)phthalimide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Remarks:

Statement of GLP compliance No. G-026

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(cyclohexylthio)phthalimide

EC Number:

241-774-1

EC Name:

N-(cyclohexylthio)phthalimide

Cas Number:

17796-82-6

Molecular formula:

C14H15NO2S

IUPAC Name:

N-(cyclohexylthio)phthalimide

Details on test material:

Test batch No.: 041/07
Active substance: 99,42 % weight
Weight loss: 0,08 % weight
Toluene insolubles: 0,05 % weight
Ash: 0,008 % weight
Melting point: first liquid 92,3°C
complete liquid 92,5 °C
Sieve retention: 2,0 mm 0 %
0,5 mm 0 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Housing
Animals were housed in cage on bedding in groups by 5 in romm No. 132 of experimental animal house. After applocation they were housed individually.
Environment
Environmental controls for the animal room will be set to maintain 22±2°C, a relative humidity of 55±5%. The temperature and relative humidity of air will be registered and the records maintained in animal house. A minimum of 10 air changes/hour, and artificial light regime 12 h light/12 h dark. The sanitation was made according to standard operation procedure (5).
Food and Water
A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served ad libitum and unlimited supply of drinking water (5). The diet was routinely analysed by the manufacturer for nutritional components and environmental contaminants.
Acclimatisation
5 days before the beginning of treatment (1,6)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

male/female: 2000 mg/kg body weigh

No. of animals per sex per dose:

females:
1: 2000 mg/kg
2: 2000 mg/kg
3: 2000 mg/kg
male:
4: 2000 mg/kg
5: 2000 mg/kg
6: 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: Animals were observed individually after dosing at least once during the first 30 minutes., periodically during the first 24 hours, with special attention given during the 4 hours, and daily thereafter, for a total of 14 days. All observations were systematically recorded, with individual records being maintained for each animal.
We used a separate OECD Guidance Document (7) for assessing of clinical signs and conditions associated with pain, suffering, and impending death.
Observations included chenges in skin and fur, eyes and mucons membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Frequency of observations and weighing:Individual body weights of animals were determinated shortly before the test article was administered and weekly thereafter.Weights chenges after first and second week after aplication were calculated and recorded.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

None of animals died or displaying any toxicity symptoms in first 4 hours either in 14 days observation period. All of animals gain body weight after first either after second week after administration of test article. They reached body weight gains from 5 to 40 g per week. None of animals dispayed any pathological lesions.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Unclassified

Mortality:

no

Clinical signs:

other: Animals were observed individually after dosing at least once during the first 30 minutes., periodically during the first 24 hours, with special attention given during the 4 hours, and daily thereafter, for a total of 14 days. All observations were system

Gross pathology:

All test animals were subjected to grass necropsy. All grass pathologicalchanges were recorded for each animal. Animals to be sacrificed were anesthetized, exsanguinated and necrospied according to standard procedures. Uthanasia and autopsy of animal (8).

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS