1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-01-31 to 2007-03-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: data from ELINCS notification validity criteria of guideline fulfilled

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-300-7

EC Name:

-

Cas Number:

128554-52-9

Molecular formula:

Not available

IUPAC Name:

Reaction products of 12-hydroxyoctadecanoic acid and octadecanoic acid and 1,3-phenylenedimethanamine

Details on test material:

- Name of test material (as cited in study report): WAX#700

- Physical state: solid

- Lot/batch No.: 001

- Storage condition of test material: Room temperature (permissible range: 10°-30°C, actual value: 17.3°-21.8°C)

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 8 weeks
- Weight at study initiation: from 175 to 179 g
- Fasting period before study: about 18 h
- Housing:
- Diet (e.g. ad libitum): ad libitum; Pellet feed for experimental animals (MF, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): ad libitum; Tap water filtered through a 5-flm filter and irradiated by UV light


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 22.8 °C
- Humidity (%): 46.3 - 63.8 %
- Air changes (per hr): 6 to 20 times
- Photoperiod (hrs dark / hrs light): 12/12 h/d

Administration / exposure

Route of administration:

other: forced oral administration using a disposable syringe equipped with a gastric tube

Vehicle:

other: 0.5 w/v% CMC-Na solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL for the 300 mg/kg group and 200 mg/mL for the 2000 mg/kg group
- Amount of vehicle (if gavage): 10mL/kg

Doses:

Group Number of Animals
First dosing group 3 females
300 mg/kg
Second dosing group 3 females
300 mg/kg
Third dosing group 3 females
2000 mg/kg
Fourth dosing group 3 females
2000 mg/kg

No. of animals per sex per dose:

300 mg/kg 6 females
2000 mg/kg 6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observation:
All animals were observed for their mortality and clinical signs before dosing, 10 and 30 minutes, 1,3, and
6 hours after dosing (6 times in total) on the day of the administration
and were observed once daily for 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths at any dose

Clinical signs:

No abnormalities in clinical signs were noted in any animals at any dose.

Body weight:

No abnormalities in body weight gain were noted in any animals at any dose.

Gross pathology:

No abnormalities in necropsy findings were noted in any animals at any dose.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU