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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Sep - 07 Oct 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
2001
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium N-methyl-N-(1-oxododecyl)glycinate
EC Number:
268-130-2
EC Name:
Ammonium N-methyl-N-(1-oxododecyl)glycinate
Cas Number:
68003-46-3
Molecular formula:
C15H29NO3.H3N
IUPAC Name:
ammonium 2-(N-methyldodecanamido)acetate
Test material form:
other: liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4166310

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

Test animals

Species:
rat
Strain:
other: Wistar rats (Shoe:WIST)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Weight at study initiation: 136 - 141 g
- Housing: the rats were kept in transparent polycarbonate cages (Macrolone type III) with two or three in each cage. Bedding was pinewood sawdust “Lignocel-Fasern”.
- Diet: pelleted complete rodent diet Altromin 1314, (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 Sep 2004 To: 07 Oct 2004

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 female (sighting study), 4 females (main study)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed for mortality and clinical signs 30 min, 2, 4 and 6 h after the administration and thereafter daily for a period of 14 consecutive days. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: All animals showed a hunched posture and piloerection 30 min, 2 and 4 h after the application of the test item. After 6 h piloerection was still observed. From Day 1 to the end of the observation period on Day 14 the animals were free of any abnormalities
Gross pathology:
Necropsy and histopathological examination revealted no substance-related findings.

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.