Butanedioic acid, 2-sulfo-, mono(C16-18 and C18-unsatd. alkyl) esters, ammonium sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conduced non-GLP, however quality inspections were performed and it was conducted according to valid test methods. Therefore it is considered relevant, adequate and reliable for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

however quality inspections were performed demonstrating validity of the study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt

EC Number:

604-617-1

Cas Number:

147993-66-6

IUPAC Name:

Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Collector SCO 40
- Physical state: Clear liquid
- Analytical purity: 40%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: Young, adult
- Weight at study initiation: Not provided
- Fasting period before study: 16 hours (and 3 hours after application)
- Housing: Macrolon 3 cages, 5 animals per cage,softwood pellets (ARWI-Center, Essen)
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324, Fa. Altromin GmbH, 4937 Lage (Germany), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):ca. 20-25 °C
- Humidity (%): 45-60%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-05-04 To: 1989-05-19

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: CMC (carboxymethyl cellulose) 1% and Cremophor 0.5%

Details on oral exposure:

VEHICLE = 1% Carboxymethylcellulose + 0.5% Cremophor
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL.kg b.w.

Doses:

10 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation at day of application several times, thereafter 2 times daily; weighing 1 day before application, fasted at day of application, at 48 hours, 7 days and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality.

Clinical signs:

other: No findings.

Gross pathology:

No findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 was > 2000 mg/kg bw for male and female rats.

Executive summary:

The acute oral toxicity of the test item containing 40% active ingredient was tested in young Wistar rats. The test item was administered by single oral gavage as a 20% solution in 1% Carboxymethylcellulose – 0.5% Cremophor as solvent and an application volume of 10 mL/kg bw. Five rats were used per sex. The LD50 was > 2000 mg act. ingr./kg bw for male and female rats. There were no clinical obervations or changes in body weight or macroscopic pathology.