Alcohols, C11-15-secondary, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 March 2010 to 09 April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to internationally accepted guidelines and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry ofAgriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nohsan No 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, secondary C11-15, ethoxylated

EC Number:

614-295-4

Cas Number:

68131-40-8

Molecular formula:

C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3

IUPAC Name:

Alcohols, secondary C11-15, ethoxylated

Details on test material:

- Name of test material (as cited in study report): Softanol 30
- Physical state: Slightly yellow clear liquid
- Analytical purity: 100%
- Purity test date: Not given
- Lot/batch No.: 9G28W1
- Expiration date of the lot/batch: End of July 2010
- Storage condition of test material: Ca. 4°C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 225 to 234 g
- Fasting period before study: overnight prior to and approximately four hours after dosing.
- Housing: They were housed in groups of three rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Diet (e.g. ad libitum): Rat and Mouse No.1 Maintenance Diet ad libitum except for overnight prior to and approximately four hours after dosing.
- Water (e.g. ad libitum): ad libitum from public supply
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): not reported, the animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 24 March 2010 To: 09 April 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As some previous toxicological information indicated that the test material should not be toxic the
initial dose level was 2000 mg/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females (3 dosed first, results assessed then a further 3 dosed)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Day 1 frequent intervals, on subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: all rats humanely killed on day 15 for macroscopic examination
- Other examinations performed: clinical signs, bodyweight, organ weights, histopathology, other: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: Clinical signs of reaction to treatment comprised loose faeces, reduced body tone, underactivity, unsteady gait, elevated gait and piloerection seen in all females dosed at 2000 mg/kg. These signs were first noted from approximately thirty minutes after d

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information: or unclassified (CLP)

Conclusions:

The acute median lethal oral dose (LD50) to rats of SOFTANOL 30 was demonstrated to be greater than 2000 mg/kg bodyweight. SOFTANOL 30 is included in Category 5 or unclassified, according to the Globally Harmonised System (GHS), (UNITED NATIONS, 2005).

Executive summary:

In an acute oral toxicity study realised according to the OECD guideline 423 and in compliance with GLP, groups of 3 female Sprague Dawley rats were given a single oral dose of  Softanol 30 in corn oil at the dose of 2000mg/kg and observed for 14 days.

There were no deaths during the study. Clinical signs of reaction to treatment were first noted from approximately thirty minutes after dosing and had resolved completely by Day 5. The acute median lethal oral dose (LD50) to female rats of SOFTANOL 30 was demonstrated to be greater than 2000 mg/kg bodyweight.