2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Jul - 08 Aug 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 1996

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

adopted June 1996

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF) Nov. 2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): AF-654
- Physical state: white powder
- Lot/batch No.: #CE-201
- Expiration date of the lot/batch: 01 Jan 2005
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: female (mean) 230 ± 32 g; male (mean) 358 ± 19 g
- Fasting period before study: over night
- Housing: 3 animals per sex per cage in labelled Makrolon type IV cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (Altromin, code VRF 1), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1 - 24.5
- Humidity (%): 47 - 79
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

The dose level of 2000 mg/kg bw was reached by administration of two times 1000 mg/kg bw (10 mL/kg bw) within 24 hours. The first on t=0 and the second on approx. t=1 hour.

VEHICLE
- Amount of vehicle (if gavage): Two administrations of formulation of the test substance at 10 mL/kg bw
- Justification for choice of vehicle: vehicle was selected based on trial formulations performed at the testing laboratory

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1st step: 3 females
2nd step: 3 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed twice daily. Animals were observed at periodic intervals on the day of dosing and once daily thereafter for clinical signs. Weighing was done prior to dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According to OECD Guideline 423, Annex 2d, a cut-off value of 5000 mg/kg bw was derived based on a limit test with 2000 mg/kg bw, since no mortality occurred in any step.

Mortality:

No mortality occurred.

Clinical signs:

Clinical signs were noted in all animals between days 1 and 3 and included lethargy, hunched posture, uncoordinated movements and piloerection in all animals. In addition, ptosis were noted in all males on day 1.

Body weight:

Body weight gain was normal during the study.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

Table 1. Table for acute oral toxicity

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
2000	0/3/3	Day1 – Day2	---	0
Females
2000	0/3/3	Day1 – Day3	---	0
LD50 > 2000 mg/kg bw

 Day 1 refers to the day of test substance administration.                                                                                    

* first number = number of dead animals                                 

  second number = number of animals with clinical signs         

  third number = number of animals used

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified