AERO 5100 PROMOTER

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Apr - 19 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted 17 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

434-440-3

EC Name:

-

Cas Number:

86329-09-1

Molecular formula:

C8H15NSO

IUPAC Name:

O-(2-methylpropyl) prop-2-en-1-ylcarbamothioate

Test animals

Species:

rat

Strain:

other: Hsd:Sprague-Dawley(CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: approx. 5 - 7 weeks
- Weight at study initiation: 115 - 140 g
- Fasting period before study: overnight prior to and for approx. 4 h after dosing
- Housing: in groups of up to 5 animals of the same sex in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel, 20 cm high x 39 cm wide x 39 cm long)
- Diet: RM1(E) SQC expanded pellet (Special Diet Services), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 24
- Humidity (%): 34 - 60
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.505 mL/kg bw

Doses:

Range-finding study: 500 and 2000 mg/kg bw
Main study: 500 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 1 female
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed at least twice daily for mortality. Individual body weights were recorded on Day 1 (prior to dosing) and 8 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at least twice daily for mortality. Individual body weights were recorded on Day 1 (prior to dosing), 2, 3, 4, 8 and 15 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:

The results from the preliminary study demonstrated the non-lethal dose to be below 2000 mg/kg bw and in accordance with the test guideline criteria and on the basis of findings at 500 mg/kg bw. No further preliminary study animals were used as findings at 500 mg/kg bw indicated this dosage to be suitable for use in the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Range-finding study: No mortality was observed at 500 mg/kg bw. The animal at 2000 mg/kg bw was sacrificed approx. 24 h after dosing for ethical reasons.

Main study: No mortality occurred during the study period of the main study.

Clinical signs:

other: Range-finding study: Piloerection, hunched posture, waddling/unsteady gait, lethargy, abnormal respiration (characterised by increased, decreased and gasping/noisy respiration), partially closed eyelids, pallid extremities, walking on toes, increased sali

Gross pathology:

Range-finding study: No abnormalities were noted at 500 mg/kg bw. Macroscopic examination of the sacrificed animal revealed congestive changes (characterised by dark tissue/prominent blood vesseld) in the subcutaneous tissue, brain, heart, liver, spleen, kidneys and along the alimentary tract. Additionally, enlarged/swollen tissues and fluid contents were observed along the alimentary tract.

Main study: No abnormalities were observed at macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are met, Category 4 classification is required according to Regulations (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in male and female rats a LD50 value > 500 - < 2000 mL/kg bw was found.