Reaction product of 9-Octadecenoic acid, (Z)-, sulfonated, potassium salts, hydrogen peroxide and sulfuric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2011-08-05 to 2011-09-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. Since there was no top dose the study has been assigned a reliability score of 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

(no top dose following flow chart due to corrosivity of the test material)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: Sprague Dawley Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Margate, UK
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 180 - 192 g
- Housing: groups of 3
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): 44 - 63 %
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: see "Details on oral exposure"

Details on oral exposure:

VEHICLE
The vehicle used in this study was 20 % (v/v) "Labrasol" in acetate buffer (0.1 M acetic acid and 0.1 M sodium acetate anhydrous). This was selected on the basis of a pre-study formulation trial which found the following vehicles to be unsuitable since none produced a satisfactory solution: 0.9 % (w/v) sodium chloride solution, 10 % propylene glycol in 0.9 % sodium chloride solution, Milil-Q water, propylene glycol in Milli-Q water and 0.2 % Tween in Milli-Q water. All vehicles were tested at a concentration of 3 mg/mL.

CLASS METHOD
- Rationale for the selection of the starting dose: it was decided that the test material formulation should not exceed 3 mg/mL because of the risk of corrosivity. An initial dose level of 50 mg/kg was selected for group 1 animals. All animals survived and there were no adverse signs in any animal. Consequently, it was decided to increase the concentration of the formulation to 7.5 mg/mL in order to achieve a dose level of 300 mg/kg for group 2 animals. Only a single, transitory adverse sign was recorded and so a third group of animals was treated at the same dose level. There were no adverse signs in any animal in this group. However, since higher concentrations of test material administered formulations carried a potential to cause corrosivity, no further treatment was deemed necessary.

Doses:

50, 300 mg/kg

No. of animals per sex per dose:

3 females per goup
(3 females dosed at 50 mg/kg and two groups of 3 females dosed at 300 mg/kg)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were checked twice daily for viability and once daily for clinical observations. The body weight of each animal was recorded before dosing on day 1 and on days 8 and 15.
- Necropsy of survivors performed: yes. Necropsy consisted of an examination of the cranial, thoracic and abdominal organs and tissues in situ.

Statistics:

No formal statistical analysis was conducted.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Based on:

test mat.

Mortality:

There were no unscheduled deaths.

Clinical signs:

other: Adverse clinical signs were restricted to hunched posture, which was recorded in one animal that received 300 mg/kg. This sign was observed at approximately 1 hour and approximately 1¾ hours after administration of the second dose fraction. No other adver

Gross pathology:

There were no macroscopic abnormalities at necropsy on day 15.

Applicant's summary and conclusion

Interpretation of results:

other: The EU criteria for classification could not be applied since the test material was not administered at the 2000 mg/kg dose level.

Conclusions:

Under the conditions of the study, the LD50 of the test material was determined to be in excess of 300 mg/kg.

Executive summary:

The acute oral toxicity of the test material was investigated under GLP conditions in accordance with the standardised guideline OECD 423. During the study the test material was administered to three groups of female rats, by oral gavage, at concentrations of 50 and 300 mg/kg. Mortality, clinical signs and body weight were recorded and a gross necropsy was performed on all animals. Under the conditions of the study there were no unscheduled deaths. Clinical signs were restricted to hunched posture, which was recorded in one animals that received 300 mg/kg. This sign was observed at approximately 1 hour and approximately 1¾ hours after administration of the second dose fraction. No other adverse signs were recorded. Body weight gains were considered to be acceptable for rats of this age and strain and no macroscopic abnormalities were recorded in any animal. The LD50 of the test material was subsequently determined to be in excess of 300 mg/kg.