Fatty acids, C12-14, .alpha.-sulfo, disodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 Nov 2016 to 08 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 17, 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

May 30, 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147

Version / remarks:

November 24, 2000

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:

tetrasodium 2-sulfonatododecanoate 2-sulfonatotetradecanoate

Cas Number:

2156594-77-1

Molecular formula:

Unspecified

IUPAC Name:

tetrasodium 2-sulfonatododecanoate 2-sulfonatotetradecanoate

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: BASF SE
- Lot/batch No. of test material: Ra-He 2014-054
- Expiration date of the lot/batch: October, 2017
- Purity test date: 100% UVCB
- Appearance: solid / beige

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han) SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: between 170 - 180 g
- Fasting period before study: 16 hours
- Housing: caged individually in Makrolon cage, type III
- Bedding: H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Enrichment: Wooden gnawing blocks (Type NGM E-022) ; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature(°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): Approx. 10
- Photoperiod: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5, 2.5 and 10 g/100 mL
- Amount of vehicle: 20 mL/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.

DOSAGE PREPARATION
The test item preparation for each test group was produced shortly before administration by stirring with a magnetic stirrer. The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.

TEST GROUPS
- Test group 1: 2000 mg/kg bw in 1 administration
- Test group 2: 500 mg/kg bw in 1 administration
- Test group 3: 500 mg/kg bw in 2 administrations

Doses:

500 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Observation period: 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter, on the last day of observation and on the day of death starting with study day 1.
- Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived
- Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. Necropsy of all animals that died as early as possible after death.
- Histology: No histological examinations were performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

- All animals of the single 2000 mg/kg bw test group died on study day 1 after administration.
- No mortality occurred in both 500 mg/kg bw test groups.

Clinical signs:

other: - Clinical signs in the single 2000 mg/kg test group revealed in all animals impaired general state and piloerection at hour 5 or from hour 4 until hour 5 after administration, while dyspnea and cowering position were seen at hour 5. All animals were foun

Gross pathology:

- The following macroscopic pathologic findings were observed in the animals that died in the 2000 mg/kg bw test group (3 females): strong filled stomach, mustard discolored contents, strong red discoloration of the glandular stomach, strong red discoloration of the small intestine, congestion of the kidneys.
- There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (both 500 mg/kg bw. groups, 6 females).

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria