Fatty acids, C18-unsatd., dimers, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-01 to 2012-05-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 December 17, 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

as of December 2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

of 30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bioassay Labor für biologische Analytik GmbH INF 515, 69120 Heidelberg

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18-unsatd., dimers, ethoxylated

EC Number:

614-587-1

Cas Number:

68551-92-8

Molecular formula:

Unspecified

IUPAC Name:

Fatty acids, C18-unsatd., dimers, ethoxylated

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: female: 174 ± 4.58 g (group 1) 175 ± 7g (group 2)
- Fasting period before study: yes
- Housing: Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): 30 – 70 %
- Air changes (per hr): Approx. 10
- Photoperiod: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.07 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: In the first test group all animals showed impaired general state, dyspnoea and piloerection from hour 1 until study day 1 after application. In the second test group two animals show impaired general state, dyspnoea and piloerection from hour 3 until hou

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (2000 mg/kg bw, 6 females).