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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-995-6 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 21606-2008 Chemicals - Test method of acute dermal toxicity
- Version / remarks:
- Chinese National Standard
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)
- Cas Number:
- 1434133-00-2
- Molecular formula:
- C47H96N3O5+ C3H5O3-
- IUPAC Name:
- Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)
- Test material form:
- solid: bulk
- Details on test material:
- Batch ST02697671
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TianQing biotechnology Ltd. ChangSha, China
- Weight at study initiation: 207 - 229 g bw
- Fasting period before study: -
- Housing: SPF Barrier environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 57 - 68 %
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: approx. 10 percent of body surface area
- Type of wrap if used: surgical gauze patch and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done):with room temperature tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.6.mL/100 g bw
- Concentration (if solution): 833.3 mg/mL - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- 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: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: no detectable clinical signs occurred
- Gross pathology:
- no abnormal necropsy findings
Applicant's summary and conclusion
- Conclusions:
- The acute dermal LD50 of REWOSOFT TE 19L for male and female rats was estimated to be over 5000 mg/kg.
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.
