Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data have been obtained from a publication of a study on a substance with structural similarity. The test was performed under GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Three generation reproduction study with dioctyl sodium sulfosuccinate in rats.
- Author:
- MacKenzie K, Henwood S, Foster G, Akin F, Davis R, Debaecke P et al.
- Year:
- 1 990
- Bibliographic source:
- Fundam. Appl.Toxicol. 15(1):53-62, 1990
Materials and methods
- Principles of method if other than guideline:
- Three-generation study by feeding administration on diet.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dioctyl Sodium Sulfosuccinate (DSS)
- IUPAC Name:
- Dioctyl Sodium Sulfosuccinate (DSS)
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 weeks, no littermates
- Diet: basal (ground Purina Certified Rodent Chow N.5002)
- Acclimation period: 4 weeks
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- acetone
- Details on exposure:
- DIET PREPARATION
Test diets (ground Purina Certified Rodent Chow No. 5002) containing dioctyl sodium sulfosuccinate (DSS) dissolved in acetone were mixed weekly.
EXPOSURE BY DIET
F0: female rats) were fed the basal diet or a test for 10 and 2 weeks, respectively.
F1: groups of 30 male and 30 female F1 animals were fed the same dose levels for at least 10 weeks postweaning, and the breeding program was repeated to produce F2 animals
F2: feeding procedure was repeated with F2 animals to produce F3 offspring. - Details on mating procedure:
- Three-generation study:
Female rats fed (F0) were mated to produce an F1 litter.
Sibling and half-sibling mating were avoided.
F2 animals were produced;
F3 offspring were produced. - Details on analytical verification of doses or concentrations:
- Samples of test diets were assayed periodically for DSS to verify homogeneity and stability of DSS after storage.
- Duration of treatment / exposure:
- 2 -1 0 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.1 % DSS
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0.5 %DSS
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1 %DSS
Basis:
nominal in diet
- No. of animals per sex per dose:
- P: groups of 30 male and 30 female
F1: groups of 30 male and 30 female
Examinations
- Parental animals: Observations and examinations:
- BODY WEIGHT: recorded weekly for males and before mating, Days 0, 7, 14 and 20 of gestation and Days 0, 7, 14 and 21 of lactation for females.
FOOD CONSUMPTION: was recorded on males and females weekly before mating, and twice weekly during gestation and lactation (females only). - Litter observations:
- Individual pup weights and the number of pups born live or found dead were recorded on lactation Day 0.
Intact dead pups were examined and preserved.
The number and sex of pups and individual pup weights were recorded on lactation Day 4.
Pups were culled from litters to achieve a maximum of 10 (5 of each sex if possible)/ litter.
Pups were weighed and examined externally on Days 7, 14 and 21 of lactation. - Postmortem examinations (parental animals):
- All F0, F1 and F2 animals were observed twice daily during the study and subjected to gross necropsy upon study termination.
- Postmortem examinations (offspring):
- Twenty weanlings/sex/group from the F3 litter were necropsied.
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. - Statistics:
- Statistical Analyses:
Body weight, food consumption, reproductive indices, precoital interval, length of gestation, pup viability and body weight, sex ratios and litter size (alive and dead by sex) were analysed using a oneway ANOVA.
When necessary, data were transformed to achieve homogeneity. Dunnett's t-test was used to compare means of groups analysed by ANOVA. Data that could not be transformed to homogeneity were analysed nonparametrically, using a Kruskal-Wallis test.
The Nemenyi, Nemenyi-Kruskal-Wallis or Wilcoxon-Mann-Whitney two sample rank test were used compare non parametric means.
Reproductive indices and the total number of live and dead pups were analyzed by the Cochran-Armitage test for trend and the Fisher-Irwin exact test for heterogeneity.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not examined
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
F0, F1 and F2 males treated with 1.0% DSS was significantly less than controls at week 4, weeks 2, 4, 8, and 10, and weeks 2 and 10, respectively.
There was no consistent effect of any dose on food consumption in females.
Body weights of F1 males and females treated with 1.0% (131 and 114 g, respectively) were lower than controls(149 and 127 g, respectively) and final weights of F1 (447 g) and F2 (467 g) males and females(255 and 269 g, respectively) treated with 1.0% and F2 males treated with 0.5% (492 g)were lower than their respective controls (510 and 531 g for F1 and F2males, and 281 and 285 g for F1 and F2 females, respectively).
Mean birth weight of male (6.1 g) and female (5.8 g) pups born to animals treated with 1.0% were significantly lower than control (6.7 and 6.4, respectively).
REPRODUCTIVE INDICES:
There was no effect of treatment on the total number of pups (ranged from 326 for F3 treated with 0.1% to 416 for F1 control) or litters [ranged from 25 for F3 treated with 0.1% to 30 for four other groups (F1 control, 0.1 and 1.0% F1 and 1.0% F2)], litter size (ranged from 5.9 for F1 males treated with 1.0% to 7.2 for female F2 control) or sex ratio (ranged from 47.2 for F2/1.0% to 51.5 for F2/0.5%).
Perinatal pup survival across the three generations was 99% for controls and ranged from 96% (for F3 generation of animals treated with 1.0%; significantly different from control of 99%) to 100% for the treated groups.
The pup survivability ranged from 95-100% for controls, from 98-100% for low- and mid-dose groups and from 91-99% for the high dose group (no effect of treatment). There were no treatment related mortality and antemortem or microscopic observations in any animals examined (F0, F1 and F2 adults and F3
weanlings).
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- not examined
Details on results (F1)
all three generations of male and female pups born to animals treated with 0.5% (43, 43 and 49 g for F1, F2 and F3 males and 41, 42 and 46 g for females) or 1.0% (36, 36 and 38 g for F1, F2 and F3 males and 34, 35 and 37 g for females weighed significantly less than controls on Day 21 (47, 49 and 54 g for F1, F2 and F3 males and 45, 46 and 51 g for females, respectively).
No milk was found in the abdomens on lactation day 4 in 3 control F2 pups, 7 F2 pups in the 0.1% dose group, 18 F2 pups and 1 F3 pup in the 0.5% dose group, and 10 F2 pups and 17 F3 pups in the 1.0% dose groups.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 0.1 other: %
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL listed is for effect on lactation and pup weight on Day 21.
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEC
- Generation:
- F2
- Effect level:
- 0.1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL listed is for effect on lactation and pup weight on Day 21.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 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.
NOAECs for P, F1 and F2 generation, based on the effect on lactation and pup weight on Day 21 were 0.1 % of DSS dose in diet. - Executive summary:
Diet containing 0.1, 0.5 or 1.0 Dioctyl Sodium Sulfosuccinate (DSS) dissolved in acetone was administered to a groups of 30 male and 30 female rats for 10 and 2 weeks. These animals (F0)were then mated to produce an F1 litter.
Groups of 30 male and 30 female F1 animals were fed the same dose levels for at least 10 weeks postweaning, and the breeding program was repeated to produce F2 animals.
The same feeding and mating procedure was repeated with F2 animals to produce F3 offspring. The study was terminated upon weaning of the F3 generation.
Individual pup weights and the number of pups born live or found dead were recorded on lactation Day 0.
The number and sex of pups and individual pup weights were recorded on lactation Day 4.
Pups were weighed and examined externally on Days 7, 14 and 21 of lactation.
Twenty weanlings/sex/group from the F3 litter were necropsied.
Weanlings not selected for mating or necropsy were examined externally.
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.
Body weights were recorded weekly for males and before mating, Days 0, 7, 14 and 20 of gestation and Days 0, 7, 14 and 21 of lactation for females. Food consumption of males and females was recorded weekly before mating, and twice weekly during gestation and lactation (females only).
Statistical Analyses were done.
RESULTS:
Food consumption of F0, F1 and F2 males treated with 1.0% DSS was significantly less than controls at week 4, weeks 2, 4, 8, and 10, and weeks 2 and 10, respectively.
There was no consistent effect of any dose on food consumption in females.
Body weights of F1 males and females treated with 1.0% (131 and 114 g, respectively) were lower than controls (149 and 127 g, respectively) and final weights of F1 (447 g) and F2 (467 g) males and females (255 and 269 g, respectively) treated with 1.0% and F2 males treated with 0.5% (492 g)were lower than their respective controls (510 and 531 g for F1 and F2males, and 281 and 285 g for F1 and F2 females, respectively). Mean birth weight of male (6.1 g) and female (5.8 g) pups born to animals treated with 1.0% were significantly lower than control (6.7 and 6.4, respectively).
All three generations of male and female pups born to animals treated with 0.5% (43, 43 and 49 g for F1, F2 and F3 males and 41, 42 and 46 g for females) or 1.0% (36, 36 and 38 g for F1, F2 and F3 males and 34, 35 and 37 g for females weighed significantly less than controls on Day 21 (47, 49 and 54 g for F1, F2 and F3 males and 45, 46 and 51 g for females, respectively). No milk was found in the abdomens on lactation day 4 in control F2 pups, 7 F2 pups in the 0.1% dose group, 18 F2 pups and 1 F3 pup in the 0.5% dose group, and 10 F2 pups and 17 F3 pups in the 1.0% dose groups.
Reproductive indices: There was no effect of treatment on the total number of pups (ranged from 326 for F3 treated with
0.1% to 416 for F1 control) or litters [ranged from 25 for F3 treated with 0.1% to 30 for four other groups (F1 control,
0.1 and 1.0% F1 and 1.0% F2)], litter size (ranged from 5.9 for F1 males treated with 1.0% to 7.2 for female F2 control)
or sex ratio (ranged from 47.2 for F2/1.0% to 51.5 for F2/0.5%).
Perinatal pup survival across the three generations was 99% for controls and ranged from 96% (for F3 generation of animals treated with 1.0%; significantly different from control of 99%) to 100% for the treated groups.
The pup survivability ranged from 95-100% for controls, from 98-100% for low- and mid-dose groups and from 91-99% for the high dose group (no effect of treatment). There were 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.
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.