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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

Constituent 1
Chemical structure
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- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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:
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 state, dyspnoea, piloerection and abdominal position were observed at hour 4 only.

2nd group:
In the second test group impaired general state, dyspnoea and piloerection were noticed from hour 1, 3, or 4 until hour 5 after administration.
Body weight:
The mean body weight of the surviving animals increased within the normal range throughout the study period, with exception of one animal of the first test group, which did not adequately gain weight during the second post-exposure week.
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

Applicant's summary and conclusion

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