Pentyl 2-cyano-(3-(6-methoxybenzothiazol-2-ylimino)-2,3-dihydro-1H-isoindol-1-ylidene)acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 22, 2000 to Nov. 24, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): FC 84508

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 wk
- Weight at study initiation: 233± 8.5 g (males); 194± 4.2 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Aug. 22, 2000 To: Sep. 05, 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Tylose H 4000 G4 PHA (0.5 % in deionized water)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was suspended in the Tylose H 4000 G4 PHA (0.5 % in deionized water) and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight- Yes

Statistics:

not applicable

Results and discussion

Preliminary study:

No

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: With exception of discolored orange faeces, between 4 h and Day1 after administration, no clinical signs were observed until the end of the study.

Gross pathology:

No gross pathology changes observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the acute oral LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1. and OECD guideline 401 in compliance with GLP.

Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in Tylose H 4000 G4 PHA (0.5 % in deionized water), at a dose level of 2000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. With exception of discolored orange feces, between 4 h and Day 1 after administration, no clinical signs were observed until the end of the study. Development of body weight was not impaired, except one female, which suffered a loss of weight between Day 8 and Day 15. No abnormalities were noted at necropsy.

 

Under the test conditions, the acute oral LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats.