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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 290-844-8 | CAS number: 90268-43-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Non reprotoxic
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Dioctyl Sodium Sulfosuccinate (DSS) was administered to rats for 10 and 2 weeks in a three-generation study.
All F0, F1 and F2 animals were observed twice daily during the study and subjected to gross necropsy upon study termination. Organs grossly examined at necropsy were colon, duodenum, epididymides, ileum, jejunum, kidneys, liver, mammary gland (with skin), ovaries, prostate, seminal vesicles, stomach, testes, uterus and vagina.
There was no consistent effect of any dose on food consumption in females and but weight loss was observed during the treatment.
Reproductive indices: no effect of treatment on the total number of pups or litters, litter size or sex ratio.
Perinatal pup survival across the three generations ranged from 96% to 100% for the treated groups.
The pup survivability ranged from 98-100% for low and mid dose groups and from 91-99% for the high dose group (no effect of treatment).
No treatment related mortality and antemortem or microscopic observations in any animals examined (F0, F1 and F2 adults and F3 weanlings).
The NOAEL for effect on lactation and pup weight on Day 21 were defined at 0.1 % of DSS on diet.
DSS at 0.5 and 1.0% affected lactation. Reduced body weights in animals receiving 0.5 or 1.0% did not interfere with growth and development or normal reproductive performance.
Justification for selection of Effect on fertility via oral route:
This three-generation study gives significant information on the Sulfosuccinic part of the registering substance (represented in the study by Dioctyl Sodium Sulfosuccinate). Reproductive indices and observation on lactation are reported.
Effects on developmental toxicity
Description of key information
Data of developmental toxicity on humans are available (see section 7.10)
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Data of developmental toxicity on humans are available (see section 7.10)
Justification for classification or non-classification
Additional information
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.
