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EC number: 947-394-9 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 1-methoxy-1-oxohexadecane-2-sulphonate
- EC Number:
- 223-676-0
- EC Name:
- Sodium 1-methoxy-1-oxohexadecane-2-sulphonate
- Cas Number:
- 4016-24-4
- Molecular formula:
- C17H34O5S.Na
- IUPAC Name:
- Sodium 1-methoxy-1-oxo-2-hexadecanesulfonate
- Reference substance name:
- Sodium 1-methyl 2-sulphonatotetradecanoate
- EC Number:
- 223-675-5
- EC Name:
- Sodium 1-methyl 2-sulphonatotetradecanoate
- Cas Number:
- 4016-22-2
- Molecular formula:
- C15H30O5S.Na
- IUPAC Name:
- Sodium 1-methoxy-1-oxo-2-tetradecanesulfonate
- Test material form:
- solid
- Details on test material:
- - Lion Corporation Lot No 000203
- Overall purity 97.0% (impurities disodium alpha-sulfopalmitate, sodium methylsufate, palmitic acid)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crj: CD(SD)IGS
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- - Pre-mating exposure period: 14 days (males and females)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- - Males: 47 days
- Females: 42-45 days (from 14 days before mating to Day 4 of lactation) - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 80 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS
- General condition was observed once a day.
BODYWEIGHT
- Bodyweights of males were determined on Day 1 (before dosing) and on Days 8, 15, 22, 29, 36, 43 and 49 of treatment.
- Bodyweights of females were determined on Day 1 (before dosing), on Days 1, 8 and 15 of treatment, on Days 0, 7, 14 and 20 of gestation, on Days 0 and 4 of lactation, and on the day of autopsy.
FOOD CONSUMPTION
- Food consumption by males was determined on Days 1, 8, 15, 22, 29, 36, 43 and 48 of treatment.
- Food consumption by females was determined on Days 1, 8 and 15 of treatment, on Days 0, 7, 14 and 20 of gestation, and on Days 0 and 4 of lactation.
- Food consumption of males and females was not determined during the mating period.
URINALYSIS
- Urinalysis was performed for all males on Day 41 or Day 42 of the administration period.
HEAMATOLOGY AND BIOCHEMISTRY
- Investigations were performed at the time of necropsy (after 48 days for males and 5 days after delivery for females).
ORGAN WEIGHTS
- Organ weights from male animals measured at the time of necropsy were brain; heart; liver; kidney; spleen; adrenal; thymus; testis and epididymis.
- Organ weights from female animals measured at the time of necropsy were brain; heart; liver; kidney;spleen; adrenal; thymus.
- Organ weight was determined for 10 males from the control group; 10 males from the 5 mg/kg bw/day group; 9 males from the 20 mg/kg bw/day group; 10 males from the 80 mg/kg bw/day group; 10 males from the 300 mg/kg bw/day group.
- Organ weight was determined for 7 females from the control group; 8 females from the 5 mg/kg bw/day group; 9 females from the 20 mg/kg bw/day group; 10 females from the 80 mg/kg bw/day group; 9 females from the 300 mg/kg bw/day group.
MICROSCOPIC EXAMINATION
- Organs examined in all animals were brain; spinal cord; intestine; liver; kidney; adrenal; spleen; heart; thymus; thyroid; parathyroid; trachea; lung; uterus; ovary; urinary bladder; ischiadic nerve; bone marrow; mesentery lymph node; mandibular lymph node; submandibular gland.
- The sublingual gland from 5 males and 5 females in the 0 and 300 mg/kg bw/day groups was examined.
- The stomach from 5 males and 5 females in the 5, 20 and 80 mg/kg bw/day groups was examined. - Ovaries and uterine content:
- - Numbers of corpora lutea and number of implantation sites were considered.
- Fetal examinations:
- - Pups were examined for external and internal malformations.
- Statistics:
- STATISTICAL METHODS
- Dunnett's or Scheffe's test for continuous data.
- Chi square test for quantal data. - Indices:
- - Number of pairs with successful copulation.
- Number of pregnant females.
- Copulation index (number of pairs with successful copulation / number of pairs mated * 100).
- Fertility index (number of pregnant animals / number of animals with successful copulation * 100).
- Estrous cycle.
- Number of pregnant females with live pups.
- Gestation length.
- Number of corpora lutea.
- Number of implantation sites.
- Number of pups born.
- Number of pups alive on Day 0 of lactation.
- Sex ratio.
- Number of dead pups.
- Gestation index (number of females with live pups / number of pregnant females * 100).
- Implantation index (number of implants / number of corpora lutea * 100).
- Live birth index (number of live pups born / number of pups born * 100)
- Viability index on Day 4 (number of live pups on Day 4 after birth / number of live pups born * 100).
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- - Transitional softening stools were observed in a few males and females in the 80 and 300 mg/kg bw/day groups.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- - No animal deaths related to treatment with test material took place.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - There were no statistically significant changes for males or females.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- - No statistically significant changes for males or females.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - No statistically significant changes for males or females.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - An increase in GPT levels and a decrease in triglyceride levels was observed in males from the 300 mg/kg bw/day group.
- No statistically significant differences were observed in females.
- Mean GPT was reported as 41 i.u./L (10 animals; 0 mg/kg bw/day; SD 4 i.u./L); 40 i.u./L (10 animals; 5mg/kg bw/day; SD 6 i.u./L); 38 i.u./L (9 animals; 20 mg/kg bw/day; SD 3 i.u./L); 44 i.u./L (10 animals; 80 mg/kg bw/day; SD 6 i.u./L); 53 i.u./L (10 animals; 300 mg/kg bw/day; SD 7 i.u./L; statistically significant p < 0.01).
- Mean triglyceride was reported as 63 mg/dL (10 animals; 0 mg/kg bw/day; SD 28 mg/dL); 43 mg/dL (10 animals; 5 mg/kg bw/day; SD 18 mg/dL); 50 mg/dL (9 animals; 20 mg/kg bw/day; SD 22 mg/dL); 49 mg/dL (10 animals; 80 mg/kg bw/day; SD 18 mg/dL); 29 mg/dL (10 animals; 300 mg/kg bw/day; SD 13 mg/dL; statistically significant p < 0.05). - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - No statistically significant changes.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - No statistically significant changes were observed for males or females.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Thickening of the forestomach mucosa was observed in the 80 mg/kg bw/day group (effect seen in 6 out of 10 males and 10 out of 10 females).
- Thickening of the forestomach mucosa was observed in the 300 mg/kg bw/day group (effect seen in 10 out of 10 males and 9 out of 9 females). - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- - Squamous hyperplasia, erosion and lamina propria and/or submucosa edema and inflammatory infiltration were observed in the forestomach of males and females in the 80 and 300 mg/kg bw/day groups (see table, below).
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- - Reproductive and developmental parameters are shown in the table below.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Treatment related:
- no
Any other information on results incl. tables
Histopathology results |
|||||
Males |
|
|
|
|
|
Dose (mg/kg bw/day) |
0 |
5 |
20 |
80 |
300 |
Number of animals examined |
5 |
5 |
5 |
5 |
5 |
Forestomach |
|
|
|
|
|
Hyperplasia, squamous (slight to severe) |
0/5 |
0/5 |
0/5 |
4/5 |
5/5 (p < 0.01) |
Erosion (slight to moderate) |
0/5 |
0/5 |
0/5 |
0/5 |
3/5 |
Edema, lamina propria/ submucosa (slight to moderate) |
0/5 |
0/5 |
0/5 |
0/5 |
4/5 (p < 0.05) |
Cellular infiltration, inflammatory cell, lamina propria/ submucosa (slight to moderate) |
0/5 |
0/5 |
0/5 |
0/5 |
4/5 (p < 0.05) |
Females |
|
|
|
|
|
Dose (mg/kg bw/day) |
0 |
5 |
20 |
80 |
300 |
Number of animals examined |
5 |
5 |
5 |
5 |
5 |
Forestomach |
|
|
|
|
|
Hyperplasia, squamous (slight to moderate) |
0/5 |
0/5 |
0/5 |
4/5 (p < 0.05) |
5/5 (p < 0.01) |
Erosion (moderate) |
0/5 |
0/5 |
0/5 |
0/5 |
1/5 |
Edema, lamina propria/ submucosa (slight to moderate) |
0/5 |
0/5 |
0/5 |
2/5 |
5/5 (p < 0.01) |
Cellular infiltration, inflammatory cell, lamina propria/ submucosa (slight) |
0/5 |
0/5 |
0/5 |
1/5 |
2/5 |
Reproductive and developmental parameters |
|||||
Dose (mg/kg bw/day) |
0 |
5 |
20 |
80 |
300 |
Estrous cycle (days) |
Mean 4.2 |
Mean 4.0 |
Mean 4.0 |
Mean 4.0 |
Mean 4.0 |
SD 0.6 |
SD 0.00 |
SD 0.0 |
SD 0.1 |
SD 0.1 |
|
Number of pairs mated |
10 |
10 |
10 |
10 |
10 |
Number of pairs copulated |
10 |
10 |
9 |
10 |
10 |
Copulation index (%) |
100 |
100 |
90 |
100 |
100 |
Number of pregnant females |
7 |
10 |
9 |
10 |
10 |
Fertility index (%) |
70 |
100 |
100 |
100 |
100 |
Number of pregnant females with parturition |
7 |
8 |
9 |
10 |
10 |
Number of pregnant females with live pups |
7 |
8 |
9 |
10 |
10 |
Gestation length (days) |
Mean 22.4 |
Mean 22.5 |
Mean 22.4 |
Mean 22.6 |
Mean 22.5 |
SD 0.5 |
SD 0.5 |
SD 0.5 |
SD 0.5 |
SD 0.5 |
|
Number of corpora lutea |
Mean 19.7 |
Mean 18.4 |
Mean 19.3 |
Mean 17.5 |
Mean 18.2 |
SD 2.8 |
SD 4.1 |
SD 3.3 |
SD 1.9 |
SD 2.6 |
|
Number of implantation sites |
Mean 15.6 |
Mean 13.2 |
Mean 14.9 |
Mean 15.9 |
Mean 15.3 |
SD 1.6 |
SD 6.3 |
SD 2.4 |
SD 1.5 |
SD 2.4 |
|
Number of pups born |
Mean 15.0 |
Mean 11.9 |
Mean 13.1 |
Mean 14.8 |
Mean 13.9 |
SD 1.7 |
SD 6.4 |
SD 4.0 |
SD 2.0 |
SD 1.7 |
|
Delivery index (%) |
Mean 96.3 |
Mean 73.8 |
Mean 85.4 |
Mean 93.3 |
Mean 91.4 |
SD 4.8 |
SD 39.4 |
SD 20.0 |
SD 10.1 |
SD 6.1 |
|
Sex ratio (male/female) |
0.78 |
0.98 |
0.97 |
0.85 |
0.88 |
Number of pups alive on Day 0 of lactation |
Mean 15.0 |
Mean 14.9 |
Mean 13.0 |
Mean 14.4 |
Mean 12.3 |
SD 1.7 |
SD 1.6 |
SD 3.9 |
SD 2.0 |
SD 4.2 |
|
Live birth index (%) |
Mean 100 |
Mean 100 |
Mean 99.3 |
Mean 97.4 |
Mean 88.3 |
SD 0 |
SD 0 |
SD 2.1 |
SD 4.6 |
SD 27.2 |
|
Number of pups alive on Day 4 of lactation |
Mean 14.7 |
Mean 14.9 |
Mean 12.9 |
Mean 14.2 |
Mean 12.0 |
SD 1.4 |
SD 1.6 |
SD 3.8 |
SD 1.8 |
SD 4.7 |
|
Viability index (%) |
Mean 98.3 |
Mean 100 |
Mean 99.3 |
Mean 98.7 |
Mean 89.3 |
SD 2.9 |
SD 0 |
SD 2.2 |
SD 2.7 |
SD 31.5 |
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for reproduction/developmental toxicity was determined to be 300 mg/kg bw/day in rats.
- Executive summary:
In a study involving an analogue substance, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test [OECD 422] was used to assess the effect of test material administered to Crj:CD (SD) IGS rats (10 animals/sex/dose) by gavage at 0, 5, 20, 80, or 300 mg/kg bw/day. Males were dosed for 47 days from day 14 before mating and females were dosed for 42-45 days from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period.Three females in the control group did not become pregnant due to abnormality of spermatogenesis in paired males. No decrease in fertility index was observed in the groups given this compound. There was no compound-related effect on the estrous cyclicity, copulation index, gestation length, numbers of corpora lutea, or number of implantation sites found in dams. No compound-related effects on the number, sex ratio, body weight, or viability were detected in pups on days 0 and 4 of lactation. No abnormal findings considered to be attributable to administration of the test material were observed in dead pups during lactation and pups at scheduled sacrifice. No external or internal malformations were also noted in pups of any groups. Based on these findings, the NOAEL for reproductive/developmental toxicity was considered to be 300 mg/kg bw/day in rats. Reproduction/developmental parameters, i.e. mating, pregnancy, delivery, lactation, and viability and body weight of pups, were not affected by the test material up to 300 mg/kg bw/day. The NOAEL for reproduction/developmental toxicity was considered to be 300 mg/kg bw/day in rats.
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