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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

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:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
EC Number:
939-538-4
Cas Number:
1471313-87-7
Molecular formula:
not applicable
IUPAC Name:
sodium 2-[(9E)-N-methyloctadec-9-enamido]ethane-1-sulfonate
Test material form:
other: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG (Hoe: WISKf(SPF71)
- Age at study initiation: 6-7 weeks (male, 7-8 weeks (female)
- Weight at study initiation:
- Fasting period before study: approximately 16 hours
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: recommended vehicle for this type of study



Doses:
2000 mg/kg body weight (limit dose)
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Gross pathology:
No effects

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was practically non-toxic after oral administration to rats.
Executive summary:

The acute oral toxicity of the registration substance was tested in 5 male and 5 female Sprague Dawley rats at a dose level of 2000 mg/kg body weight (limit test) according to OECD Guideline 401. The animals received the compound once as a 20% suspension in water as vehicle via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 60 minutes post application. From 1 hour after adminstration onwards no clinical symptoms of toxicity were observed until the end of the observation period. No mortality occurred. Body weight development was not impaired. None of the animals showed macroscopically visible changes. Based on the study results, the median lethal dose (LD50) of the registration substance is greater than 2000 mg/kg body weight in rats.