N-(cyclohexylthio)phthalimide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

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:

Animals: rats, Wistar, weight: 140-160 g
Number and sex: 3 females, 3 males - we used only 3 females and 3 males because of low acute toxicity of test article we could use limit test.
Source: Accredited Breeding Velaz Prague CZ
Identification: The animals were housed individually in cages after application. They were marked by numbers placed on the cages.
Housing:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

olive oil

Details on dermal exposure:

Determination of acute dermal toxicity is useful where exposure by the dermal route is likely. It provides information on health hazards likely to arise
from short-term exposure by the dermal route. Data from an acute dermal toxicity study serves as a basis for classification and labelling. The aim of
this study is to receive data to support registration of this test article.

Duration of exposure:

Duration: 24 hours

Doses:

2000 mg/kg: males and females

No. of animals per sex per dose:

Animals : 3 females Dose: 2000 mg/kg
3 males 2000 mg/kg

Control animals:

no

Results and discussion

Preliminary study:

We have used dosage and procedure of doses application according to OECD TG 434, Acute Dermal Toxicity - Fixed Dose Procedure, evaluation and classification according to OECD TG 423 Acute Oral Toxicity - Acute Toxic Class Method. This method is not designed to determine a point estimate of LD50, or confidence limit. It provides a range estimate of LD50 defined by cut-off values of the applied classification system and not as a calculated lower and upper level. The method provides information on hazardous properties and allows the compound to be ranked and classified according to the Globally Harmonised System (GHS) for the classification of chemicals which cause acute toxicity.

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: without symptoms

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: without symptoms

Mortality:

Death and/or any toxicity symptoms did not occur.

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 first 3 hours, and daily thereafter, for a total of 14 days. All observations were s

Gross pathology:

All test animals (including those that dead during the test) were subjected to gross necropsy. All gross pathological changes were recorded for each animal. Animals to be sacrificed were anesthetized, exsanguinated and necropsied according to standard procedures.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS