C8-18 (even numbered) and C18 (unsaturated) sarcosinates, 2-hydroxypropylammonium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Dec 2015 - 12 Jan 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study without restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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:

(adopted 17 Dec 2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(Official Journal of the European Union No. L142, May 2008, incl. most recent amendments)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(Office of Prevention, Pesticides and Toxic Items (7101), EPA 712-C-02-190, 2002)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, 12 Nousan, Notification No 8147, Nov 2000 incl. most recent revisions)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(N-methyldodecanamido)acetic acid 2-hydroxypropan-1-aminium 2-(N-methyldodecanamido)acetate

EC Number:

943-406-1

Molecular formula:

Not applicable. This substance is UVCB.

IUPAC Name:

2-(N-methyldodecanamido)acetic acid 2-hydroxypropan-1-aminium 2-(N-methyldodecanamido)acetate

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): MIPA-Cocoyl-Sarkosinat
- Substance type: organic (UVCB)
- Physical state: clear yellow-brown viscous liquid
- Analytical purity: 100%, according to definition of UVCB
- Impurities (identity and concentrations): no impurities, UVCB
- Lot/batch No.: 070715
- Expiration date of the lot/batch: 31 Dec 2016
- Stability under test conditions: stable in vehicle water
- Storage condition of test material: at room temperature
- Other: pH 5.7 - 6.0 (1% in water), density 0.993 g/mL

Test animals

Species:

rat

Strain:

other: Wistar Crl:WI (Han) (outbred, SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 145 - 158 g
- Fasting period before study: overnight prior to dosing and until 3 - 4 hours after administration of the test item
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; hight 18 cm) containing sterilized saw dust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Soehne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaeten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): at least 10 changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: The vehicle was selected based on trial preparations performed at WIL Research Europe and on test item data supplied by the sponsor.
- Purity: Elix, Millipore S.A.S., Molsheim, France

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION: The preparations (w/w) were kept at room temperature and were dosed within 4 hours after adding the vehicle to the test item. Homogeneity was assessed by visual inspection of the solutions, and the formulations were stirred during dosing, which ensures homogeneity sufficient for these kinds of studies.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 + 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability twice daily, body weights on Day 1 (pre-administration), 8 and 15, clinical signs at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes, at the end of the observation period
- Other examinations performed: clinical signs, body weight, other: all internal macroscopic abnormalities

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

other: LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and/or piloerection were noted for all animals on Days 1 and/or 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU