Sodium octyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 June 2012 - 30 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study conducted in compliance with GLP regulations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octyl sulphate

EC Number:

205-535-5

EC Name:

Sodium octyl sulphate

Cas Number:

142-31-4

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium octyl sulfate

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): Trade name given
- Substance type: pure substance
- Physical state: solid, white
- Analytical purity: 92.5% octyl sulphate, sodium salt (determined by the manufacturer, non-GLP)
- Lot/batch No.: 12076LW115
- Expiration date of the lot/batch: March 06, 2013
- Stability under test conditions: stable
- Storage condition of test material: ambient (RT); store frost-free; avoid temperatures >30 °C
- Test item No.: 12/0257-1

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Details on strain: Wistar / Crl:WI (Han)
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: mean (1st group): 169.7 ± 4.16g; mean (2nd group): 179.3 ± 10.02g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III
- Diet (ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (ad libitum): Tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Solution in deionized water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose:
By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. As only one animal died, 2000 mg/kg bw were administered to 3 female rats in the second step.

Doses:

Starting dose: 2000 mg/kg bw
Second step dose: 2000 mg/kg bw

No. of animals per sex per dose:

3 female rats per test group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time. Necropsy of the animal that died during the study as early as possible after death.
- Other examinations performed:
Clinical signs: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Body weight: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Histopathology: No histological examinations were performed.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

In the first 2000 mg/kg bw test group one animal was found dead at hour 5 after administration.
No mortality occurred in the second test group.

Clinical signs:

other: 1st group: Clinical signs in the two surviving animals of the first 2000 mg/kg bw test group revealed impaired general state, dyspnoea and piloerection from hour 1 until hour 5 after administration. In the animal that died in this test group poor general

Gross pathology:

Deceased animal:
In the animal that died in the first test group the following macroscopic pathologic findings were observed: Liquid, light discolored content in the stomach, red discoloration of the glandular stomach and small intestine.

Sacrificed animals:
There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.

Any other information on results incl. tables

Body weight changes:

Individual body weight changes
Dose [mg/kg bw]	2000					2000
Group	1					2
Animal No.	1	2	3	mean	sd.	1	2	3	mean	sd.
Body weight at study day [g]
0	165	171	173	169.7	4.16	183	187	168	179.3	10.02
7	182	182	-	182.0	0.00	195	203	187	195.0	8.00
14	184	192	-	188.0	5.66	206	212	201	206.3	5.51

sd. = standard deviation