Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 263-174-9 | CAS number: 61791-42-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- 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)
- Fasting period before study: approximately 16 hours
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: recommended vehicle for this type of study - Doses:
- 2000 mg/kg bw (limit dose)
- 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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: 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 obse
- Gross pathology:
- No effects
- Interpretation of results:
- other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- 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
- Reference substance name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-174-9
- EC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-42-2
- Molecular formula:
- UVCB
- IUPAC Name:
- Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, SPF breeding, Hoe:WISK(SPF71)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 187 g ± 7 g males, 180 g ± females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: recommended
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw (limit dose)
- 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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No lethality
- Clinical signs:
- other: Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. From day 1 until the end of the observation period no symptoms of toxicity were observed.
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS classification criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
