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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-612-0 | CAS number: 57195-28-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Dipotassium dodecenylsuccinate
- EC Number:
- 260-612-0
- EC Name:
- Dipotassium dodecenylsuccinate
- Cas Number:
- 57195-28-5
- Molecular formula:
- C16H26K2O4*H2O
- IUPAC Name:
- Dipotassium dodecenylsuccinate
- Test material form:
- liquid
- Details on test material:
- 30 % aqueous solution
pure substance is solid (bulk/powder), but is only used as aqueous solution and blends it into mixture
Substance dissolves in water at 40wt%, then becomes gel and becomes solid, if mixed 61wt% with water
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 170727
- Expiration date of the lot/batch: 2019/07/27
- Purity test date: 100% - 30% Dipotassium dodecenylsuccinate; 70% water; 100%
Test animals
- Species:
- rat
- Strain:
- other: SD, albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd, 9 Perahu Road, Lim Chu Kang, Singapore 718793
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks old at dosing
- Weight at study initiation: 202 - 286 g
- Fasting period before study: The test animals were fasted overnight before dosing; water was not withheld.
- Housing: Individual Ventilated Cage System
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324
- Water (e.g. ad libitum): tap water
- Acclimation period: The test animals were acclimatised for at least 5 days before the test was conducted.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 26
- Humidity (%): 30 - 70
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
The test substance was then administered by gavage feeding needle at a dose level of 300 mg/kg body weight (for animals in Group 1 and Group 2) and 2000 mg/kg body weight (for animals in Group 3 and Group 4) based on the body weight of each test animal.
CLASS METHOD
- Rationale for the selection of the starting dose: In this study, 4 groups of animals were dosed in total. The starting dose for Group 1 was selected at 300 mg/kg body weight based on OECD Guideline 423 and as required by sponsor. - Doses:
- 300 mg/kg body weight (for animals in Group 1 and Group 2) and 2000 mg/kg body weight (for animals in Group 3 and Group 4)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The observation was conducted on each animal during the first 30 minutes, 1, 2 and 4 hours, and daily thereafter to 14 days. The body weight of each animal was measured once a week or more frequently when adverse effect was observed.
- 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 animal died during the study.
- Clinical signs:
- other: No adverse effect was observed on all the test animals during the study.
- Gross pathology:
- No abnormality was observed on all animals during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on above results the acute oral toxicity of the test item – Dipotassium dodecenylsuccinate (aq. solution), Lot No: 170727 is considered as not classified under CLP.
Based on OECD Guideline 423, the LD50 cut-off value of the of test item is 5000 mg/kg body weight or not classified.
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.
