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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
7 Jul - 21 Jul 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of details on test material.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-lauroylsarcosinate
EC Number:
205-281-5
EC Name:
Sodium N-lauroylsarcosinate
Cas Number:
137-16-6
Molecular formula:
C15H29NO3.Na
IUPAC Name:
sodium [dodecanoyl(methyl)amino]acetate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Sprague Dawley, Crl:CD (SD) BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: young adult
- Weight at study initiation: 172 g (males) and 143 g (females)
- Fasting period before study: Healthy animals were fasted overnight prior to dosing.
- Housing: Animals were housed in single sex groups of five in grid bottomed polypropylene cages.
- Diet: Commercially available pelleted rodent diet provided, as libitum.
- Water: Mains drinking water via polypropylene bottles provided, ad libitum.
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 43-76
- Air changes (per hr): air conditioned room
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


Doses:
5000 mg/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: All animals were examined frequently after dosing and daily for fourteen consectutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes. At the end of the fourteen day observation period surviving animals were weighed and then sacrificed by carbon dioxide narcosis. Animals killed thus and those dying during the study were subjected to gross examination including the opening of the thoracic and visceral cavities.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
5000 mg/kg bw: 1/5 females died at Day 2
Clinical signs:
other: No effects of treatment were observed in surviving animals.
Gross pathology:
The female animal found dead on Day 2 had been cannibalised and autolysed. No detailed post-mortem examination was possible.
In surviving animals no abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.