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EC number: 911-616-2 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2, 2000 to May 29, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- 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:
- There are different notations of the molecular formula, dependent on whether it is depicted as protonated or not: C17H34O5S.Na C17H33NaO5S C14H29CH(CO2CH3)SO3Na CH3(CH2)13CH(SO3Na)COOCH3
- IUPAC Name:
- sodium 1-methoxy-1-oxohexadecane-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: white powder
- Storage condition of test material: cool dark place at 4ºC, airtight stopper (hygroscopical)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- strain: Crj: CD (SD) IGS
- Source:Charles River Laboratories Japan, Inc
- Age at study initiation: 8 weeks
- Weight at study initiation: 364 to 420 g for males and 223 to 264 g for females.
- Fasting period before study: no
- Housing: in individual stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Administered suspensions were prepared by mixing the substance with Japanese Pharmacopoeia-grade olive oil to designated concentration doses. - Details on mating procedure:
- Estrous cycle test:
estrous cycle stages were determined microscopically
Observation of mating and delivery:
- on Day 15 of administration. Each pair was housed together in the same cage until mating was confirmed, with two weeks as the limit. The mating rate (%) [(number of animals that had mated/number of animals housed together) x 100] was calculated. Mating was confirmed with formation of the copulatory plug or sperm in vaginal smears (day 0 of pregnancy). Observation of the delivery state was also carried out at the same time, and the day upon which completion of delivery was confirmed was designated as Day 0 of lactation. Based on the observation results of mating and delivery, the conception rate (%) [(number of females conceiving/number of females that had mated) x 100] and birth rate (%) [(number of females giving birth/number of pregnant females) x 100] were calculated. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The hexadecanoic acid, 2-sulfo-, 1-methylester, sodium salt suspensions of 0.1 w/v% (for 5 mg/kg group), 0.4 w/v% (for 20 mg/kg group), 1.6 w/v% (for 80 mg/kg group) and 6.0 w/v% (for 300 mg/kg) prepared for the first and last times were analyzed using the HPLC method. The analysis was repeated three times, and the mean values were calculated.
Date of preparation Displayed value (w/v %)
0.1 0.4 1.6 6.0
May 30, 2000 0.10 0.40 1.7 6.2
July 8, 2000 0.09 0.40 1.6 5.8
The results shown below confirm that the suspensions were prepared at the designated concentrations. - Duration of treatment / exposure:
- The administration duration ranged from 14 days before start of mating for both males and females, lasting 47 days for males and to 42 days at the shortest to 55 days at longest after birth just before day 4 of lactation for females.
- Frequency of treatment:
- once a day
- Details on study schedule:
- Premating exposure period for male and female: 14 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 20 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 80 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control:
- Not applicable.
Examinations
- Parental animals: Observations and examinations:
- See Section 7.5.1 RA 223-676-0 (OECD 422)
- Oestrous cyclicity (parental animals):
- Estrous cycle
No. of pairs with successful copulation
No. of pregnant females
No. of pregnant females with live pups gestation lenght
No. of corpora lutea
No. of implantation sites - Sperm parameters (parental animals):
- Parameters examined in all male parental generations: testis weight
- Litter observations:
- No. of pups born
No. of pups alive on day 0 of lactation
Sex ratio
No. of dead pups - Postmortem examinations (parental animals):
- See Section 7.5.1 RA 223-676-0 (OECD 422)
- Postmortem examinations (offspring):
- The main organs in the chest and abdomen were observed macroscopically in dead pups at the time of death and in live pups, which were exsanguinated under ether anesthetic on Day 4 of lactation.
- Statistics:
- See Section 7.5.1 RA 223-676-0 (OECD 422)
- Reproductive indices:
- Copulation index (No. pairs with successful copulation/No. of pairs mated x 100)
fertility index (No. of pregnant animals/No. of animals with successful copulation x 100)
gestation index (No. of females with live pups/No. of pregnant females x 100)
implantation index (No. of implants/No. of corpora lutea x 100)
delivery index (No. of pups born/No. of implants x 100) - Offspring viability indices:
- live birth index (No. of live pups born/No. of pups born x 100)
viability index on day 4 (No. of live pups on day 4 after birth/No. of live pups born x 100)
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Estrous cycle examination: No significant differences in the estrous cycle were noted between the study groups and the control group.
Mating and conception rates: All pairs successfully mated except for one in the 20 mg/kg group. No significant difference was seen in the time taken for mating. Conception in the control group was 70% because of failure in three pairs whose males exhibited abnormality of spermatogenesis, while the parameter was 100% for all study groups.
Corpora lutea count, number of implantations, and implantation rate:
No significant differences in corpora lutea count, the number of implantations, or implantation rate were found between any of the study groups and the control group.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 300 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: for offspring development, no effects observed
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Reproductive and developmental parameters: No effects of this substance were observed on reproductive performance in males and females or on viability and body weight of offspring. No malformations were found in offspring in any groups.
Dose (mg/kg bw/day) | 0 | 5 | 20 | 80 | 300 |
Estrous cycle (days) | |||||
Mean | 4.2 | 4.0 | 4.0 | 4.0 | 4.0 |
SD | 0.6 | 0.0 | 0.0 | 0.1 | 0.1 |
No. of pairs mated | 10 | 10 | 10 | 10 | 10 |
No. of pairs copulated | 10 | 10 | 9 | 10 | 10 |
Copulation index (%) | 100 | 100 | 90 | 100 | 100 |
No. of pregnant females | 7 | 10 | 9 | 10 | 10 |
Fertility index (%) | 70 | 100 | 100 | 100 | 100 |
No. of pregnant females with parturition | 7 | 8 | 9 | 10 | 10 |
No. of pregnant females with live pups | 7 | 8 | 9 | 10 | 10 |
Gestation length(days) | |||||
Mean | 22.4 | 22.5 | 22.4 | 22.6 | 22.5 |
SD | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
No. of corpora lutea | |||||
Mean | 19.7 | 18.4 | 19.3 | 17.5 | 18.2 |
SD | 2.8 | 4.1 | 3.3 | 1.9 | 2.6 |
No. of implantation sites | |||||
Mean | 15.6 | 13.2 | 14.9 | 15.9 | 15.3 |
SD | 1.6 | 6.3 | 2.4 | 1.5 | 2.4 |
No. of pups born | |||||
Mean | 15.0 | 11.9 | 13.1 | 14.8 | 13.9 |
SD | 1.7 | 6.4 | 4.0 | 2.0 | 1.7 |
Delivery index(%) | |||||
Mean | 96.3 | 73.8 | 85.4 | 93.3 | 91.4 |
SD | 4.8 | 39.4 | 20.0 | 10.1 | 6.1 |
Sex ratio(Male/female) | 0.78 | 0.98 | 0.97 | 0.85 | 0.88 |
No. of pups alive on day 0 of lactation | |||||
Mean | 15.0 | 14.9 | 13.0 | 14.4 | 12.3 |
SD | 1.7 | 1.6 | 3.9 | 2.0 | 4.2 |
Live birth index(%) | |||||
Mean | 100 | 100 | 99.3 | 97.4 | 88.3 |
SD | 0 | 0 | 2.1 | 4.6 | 27.2 |
No. of pups alive on day 4 of lactation | |||||
Mean | 14.7 | 14.9 | 12.9 | 14.2 | 12.0 |
SD | 1.4 | 1.6 | 3.8 | 1.8 | 4.7 |
Viability index | |||||
Mean | 98.3 | 100 | 99.3 | 98.7 | 89.3 |
SD | 2.9 | 0 | 2.2 | 2.7 | 31.5 |
Applicant's summary and conclusion
- Conclusions:
- No effects of the substance were observed on reproductive performance in males and females or on viability and body weight of offspring. The NOAEL was determined to be 300 mg/kg bw/day for reproductive performance of parental animals and for offspring development.
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