Reaction mass of sodium sulphate and disodium dodecanedioate and Dodecanoic acid, 12-amino-, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 July 2010 - ............................

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

the animals were not housed individually.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

idem above

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:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

IUPAC Name:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

Details on test material:

- Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate
- Substance type: UVCB (substance of unknown or variable composition, complex reaction products or biological materials)
- Physical state: brown liquid
- Purity test date: 26 march 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 September 2010
- Storage conditions of test material: at room temperature.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 198 ± 8 g
- Fasting period before study: 18 hours
- Housing: polycarbonate cages with stainless steel lid, not individually
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted diet
- Water (e.g. ad libitum): free access to bottles containing tap water (filtered with a 0.22 m filter)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00-19:00)

IN-LIFE DATES: From: 09 July 2010 To: 12 August 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: the test item was soluble in purified water at 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no information on the toxic potential of the test item was available, for animal welfare reasons,
the starting dose-level of 300 mg/kg was chosen.

Doses:

300 and 2000 mg/kg.

No. of animals per sex per dose:

3 females per treatment step (300, 2000 and 2000 mg/kg).

Control animals:

no

Details on study design:

- Duration of observation period following administration: a period of up to 14 days
- Frequency of observations and weighing: each animal was observed after dosing at least once during the first 30 minutes, periodically during the
first 24 hours for detection of possible treatment-related clinical signs and then at least once a day for 14 day.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
The body weight of each animal was recorded just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study.

Clinical signs:

other: At the dose-level of 300 mg/kg (three females), no clinical signs were observed. At the dose-level of 2000 mg/kg (three females then confirmation on three other females), ptyalism and loud breathing were noted in one animal within one hour of treatment,

Gross pathology:

Macroscopic post-mortem examination of the main organs of the animals revealed no apparent abnormalities.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008

Conclusions:

The oral LD50 of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T710/712), was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the toxicity of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, following a single oral administration in rats according to OECD 423 and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

Methods

The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, was administered by oral route (gavage) to groups of three fasted female Sprague-Dawley rats at dose-levels of 300 and 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in purified water.

Each animal was observed at least once a day for mortality and clinical signs for a period of up to 14 days following the single administration. Body weight was recorded on day 1 and then on days 8 and 15. On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination.

At necropsy, no apparent abnormalities were observed in any animal.

Results

No mortality was observed during the study. At the dose-level of 300 mg/kg (three females), no clinical signs were observed. When compared to CIT historical control data, the body weight gain of the animals was not affected by treatment with the test item. At the dose-level of 2000 mg/kg (three females then confirmation on three other females), ptyalism and loud breathing were noted in one animal within one hour of treatment, and piloerection was observed in another one 20 minutes after treatment. When compared to CIT historical control data, a lower body weight gain was noted in 1/6 females (vs. 41 ±in control data base) between day 1 and day 8. The body weight gain of this animal returned to normal thereafter.

Conclusion

The oral LD50of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T710/712), was higher than 2000 mg/kg in rats.