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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 827-581-0 | CAS number: -
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts
- EC Number:
- 287-024-7
- EC Name:
- Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts
- Cas Number:
- 85408-62-4
- IUPAC Name:
- 85408-62-4
- Reference substance name:
- Sodium 2-sulphonatoethyl laurate
- EC Number:
- 230-949-8
- EC Name:
- Sodium 2-sulphonatoethyl laurate
- Cas Number:
- 7381-01-3
- Molecular formula:
- C14H28O5S.Na
- IUPAC Name:
- sodium 2-(dodecanoyloxy)ethanesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Sodium Lauroyl Isethionate
- Molecular formula (if other than submission substance): Na.SO3-CH2-CH2-O-CO-(CH2)10-CH3
- Molecular weight (if other than submission substance): 344.419g/mol
- Smiles notation (if other than submission substance): [O-]S(=O)(CCOC(CCCCCCCCCCC)=O)=O.[Na+]
- InChl (if other than submission substance): no data
- Substance type: organic
- Physical state: aqueous solution
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): no data
- Specific activity (if radiolabelling): 36.8 X 10exp6 dpm/mL (1.7 uCi/mg)
- Locations of the label (if radiolabelling): 1st Carbon of Lauroyl chain
- Expiration date of radiochemical substance (if radiolabelling): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: Males: 291-333 g; Females: 172-207 g;
- Food and water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (Milli-Q-water).
- Details on mating procedure:
- Females were housed with sexually mature males (1:1) in special automatic mating cages i.e. with synchronized timing to initiate the nightly mating period, until evidence of copulation was observed. This system reduced the variation in the copulation times of the different females. The females were removed and housed individually if:
a) The daily vaginal smear was sperm positive, or b) A copulation plug was observed. The day of mating was designated day 0 post coitum.
If a female did not mate during the 14-day pairing period, this female was paired with a male of the same group which had already mated successfully. If mating was not recorded during this additional pairing period of a maximum of 14 days, the female was sacrificed and, if indicated, the reproductive organs examined histopathologically in order to ascertain the reason for the infertility. - Duration of treatment / exposure:
- Males were treated over a 15-day pre-pairing period and during the pairing period up to one day before necropsy. Females were treated throughout the pre-pairing, pairing, gestation and lactation period up to weaning on day 21 post partum.
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 12 males and 12 females per dose group
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes daily
FOOD CONSUMPTION:
Males - weekly during pre-pairing and after pairing periods.
Females - pre-pairing period days 1-8 and 8-15; gestation days 0-7, 7-14 and 14-21 post coitum, and lactation days 1-7 and 7-14 post partum (since pups begin to consume maternal feed on or about lactation day 14, food consumption was not recorded after this day).
No food consumption was recorded during the pairing period. - Oestrous cyclicity (parental animals):
- Duration of cycle was recorded
- Sperm parameters (parental animals):
- not reported
- Litter observations:
- Litters were examined for litter size, live births, still births and any gross anomalies.
Sex ratio of the pups were recorded on days 0/1, 4 and 21 post partum. Pups were weighed individually on days 0 (if possible, without identification), 1, 4, 7, 14 and 21 post partum. - Postmortem examinations (parental animals):
- The testes and epididymides of all parental males were weighed as pairs
HISTOPATHOLOGY
Slides of all organs and tissues collected at terminal sacrifice from the animals of the control and high-dose groups were examined. The same applied to the female, which was terminated in extremis. Special emphasis was made on the stages of spermatogenesis and histopathology of interstitial cell structure.
If test item-related morphologic changes were detected in organs of any high-dose animal, those same organs from the mid- and low-dose group were examined to establish a no-effect level, if possible.
Histological examination of ovaries was carried out on any females that did not give birth. In addition, microscopic examination of the reproductive organs of all infertile males was made, if necessary. - Statistics:
- Dunnett test, Steel-test, Fisher's exact test
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
CLINICAL SIGNS (OFFSPRING)
BODY WEIGHT (OFFSPRING)
SEXUAL MATURATION (OFFSPRING)
ORGAN WEIGHTS (OFFSPRING)
GROSS PATHOLOGY (OFFSPRING)
HISTOPATHOLOGY (OFFSPRING)
OTHER FINDINGS (OFFSPRING)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
General tolerability: All animals survived until scheduled necropsy, except one female at 1000 mg/kg, which died, possibly due to a dosing error.
Food consumption and bodyweight: In males at 300 and 1000 mg/kg, mean food consumption was slightly reduced. Additionally, mean body weights were reduced from the pairing period until the end of the study, whereas no clear dose-dependency was noted. Mean body weight gain was slightly reduced and recovered in the after pairing period at 300 mg/kg but not at 1000 mg/kg.
In females at 1000 mg/kg, mean food consumption was slightly reduced during the treatment period. At 300 mg/kg mean food consumption was only reduced during the second week of the lactation period. As a result, a slight transient reduction of mean body weight gain was noted in the lactation period at both dose levels. Mean body weights were similar in all groups at the end of the study.
Reproductive Data: The fertility rate was 100% in all groups. At all dose-levels, there were no treatment-related effects on estrous cycle, precoital time, mean duration of gestation, number of corpora lutea and implantations, post-implantation loss, pup survival or litter size from birth through to scheduled sacrifice on day 21 post partum.
Organ Weights: No significant deviations in mean organ weight of testes and epididymides were recorded which could be attributed to the treatment with the test item, since lower mean absolute weights of epididymides were considered to be in relation with lower body weights and no test item-related histopathological findings were present.
Macroscopical Findings and Histopathological Examinations: No test item-related histopathologic findings were observed in the reproductive organs of either sex from the parental generation. In particular, the assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired spermatogenesis.
Litter Data: No abnormal findings were noted for pups at first litter check or during the lactation period. Sex ratios at first litter check and on day 21 post partum were unaffected by treatment with the test item.
Mean pup weights on day 1 post partum and mean pup weight development during the lactation period were unaffected by treatment with the test item.
Applicant's summary and conclusion
- Conclusions:
- In a study performed to OECD 421 on SCI, the NOAEL was 1000 mg/kg body weight/day.
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.