Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 30, 2008
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
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

Constituent 1
Chemical structure
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