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EC number: 307-055-2 | CAS number: 97489-15-1
- 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
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- Nanomaterial pour density
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- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974-1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No guideline study and non-GLP but performed according to scientific standards at time of performance. Acceptable based on nowadays existing guidlines and standards. Well performed and documented. Reliability declaration regarding procedures and performance available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Two-generation reproductive toxicity study including a segment II phase for developmental toxicity
- GLP compliance:
- no
- Remarks:
- but reliability declaration from study director included
- Limit test:
- no
Test material
- Reference substance name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- EC Number:
- 307-055-2
- EC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Cas Number:
- 97489-15-1
- Molecular formula:
- H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3
- IUPAC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Reference substance name:
- Hostapur SAS 60
- IUPAC Name:
- Hostapur SAS 60
- Details on test material:
- - Name of test material (as cited in study report): Hostapur SAS
- Physical state: aqueous slurry
- Analytical purity: 60%
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 1974-09-01
- Lot/batch No.: NR T 2/112
- Expiration date of the lot/batch: 1979-10-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K.
- Age at study initiation: (P) = weanling rats
- Weight at study initiation: (P) Males: 79 +/- 3g; (P) Females: 87 +/- 3 g
- Fasting period before study: no
- Housing: polypropylene cages
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Humidity (%): 50 +/-20%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): Spratts Laboratory Diet No. 2
- Storage temperature of food: refrigerator
VEHICLE
- Justification for use and choice of vehicle (if other than water): n.a.
- Concentration in vehicle: n.a.
- Amount of vehicle (if gavage): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a. - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 60 days (three pregnancies derived from each of two generations)
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
- After 5 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged separately
- Any other deviations from standard protocol: Approximately 20 days after weaning of the first (A) litters the females were re-mated with different males to produce the second (B) litters. This was repeated a second time to produce the third (C) litters. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 60 days prior to mating and throughout three successive pregnancies (fertility)
Gestation days 6 to 15 only for females during organogenesis stage (development) - Frequency of treatment:
- daily
- Details on study schedule:
- - F1 parental animals not mated until approximately 10 weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were approximately 15 days of age.
- Age at mating of the mated animals in the study: approximately 13 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Doses / Concentrations:
0, 1000, 3000, 10000 ppm
Basis:
nominal in diet
Fertility groups 2, 3, 4
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Doses / Concentrations:
0, 1000, 3000, 10000 ppm
Basis:
nominal in diet
Developmental groups 5, 6, 7
- Dose / conc.:
- 3 000 ppm
- Remarks:
- Doses / Concentrations:
0, 1000, 3000, 10000 ppm
Basis:
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Doses / Concentrations:
0, 1000, 3000, 10000 ppm
Basis:
- No. of animals per sex per dose:
- 25 per sex per group
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based on repeated dose toxicity study and expert judgement
- Rationale for animal assignment (if not random): random
- Other: - Positive control:
- not required
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food intake per cage of five rats was recorded and the mean intake per rat calculated
OTHER: Heamtological investigations, absolute and relative organ weights, histopathological investigation of tissues - Oestrous cyclicity (parental animals):
- oestrous cycles, mating performance, conception rates and pre-coital interval were examined for all three matings
- Sperm parameters (parental animals):
- Sperm parameters not investigated in detail
- Litter observations:
- STANDARDISATION OF LITTERS
All offspring, except those selected to form the F1 generation, were killed after day 21 post partum by carbon dioxide asphyxiation and examined.
PARAMETERS EXAMINED
The following parameters were examined in [F1A, F1B, F1C, F2A, F2B and F2C offspring:
- number and sex of pups,
- stillbirths,
- live births,
- postnatal mortality,
- presence of gross anomalies,
- weight gain,
-physical or behavioural abnormalities,
The speed of physical development of the offspring was assessed by the following parameters:
- pinna unfolding
- hair growth,
- tooth eruption,
- eye opening
- auditory function,
- visual function
GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.] - Postmortem examinations (parental animals):
- SACRIFICE
- At day 13 (half of dams) or day 21 (remaining dams) of the third pregnancy all parent animals were killed and a thorough gross macroscopic examination carried out
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following organs / tissues were prepared for microscopic examination and weighed, respectively:
- heart, liver, kidneys, ovaries, testes, adrenals, spleen, lung, stomach, pancreas, thymus, small intestine, urinary bladder
pre-implantation loss and post-implantation loss were examined - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals were sacrificed at 21 days of age.
- These animals were subjected to postmortem macroscopic and/or microscopic examination
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY / ORGAN WEIGTHS
The folowing organs / tissues were prepared for microscopic examination and weighed, respectively:
- heart, liver, kidneys, ovaries, testes, adrenals, spleen, lung, stomach, pancreas, thymus, small intestine, urinary bladder - Statistics:
- Mann-Whitney non-parametric U test; chi-squared test incorporating Yates` correction
- Reproductive indices:
- Mean litter size, mean litter weight, mean offspring weight (day 1, 21, 25), mean offspring weight on day 4 post partum
- Offspring viability indices:
- Viability index, live birth index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
showed no adverse treatment-realted effects. A slight depression of body weight gain was observed in the F0 generation in the highest dose group. No significant inter-group variation was observed during the three subsequent pregnancies. In both parental generations (F0 and F1) oestrous
cycles, mating performance and conception rates were unaffected by treatment.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: P, F1a, F1b, F2a, F2b (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 000 - <= 10 000 ppm (nominal)
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: F1a, F2b (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Other effects:
- no effects observed
Details on results (P1)
Slight body weight gain depression in animals of the highest dose group (10000 ppm) (continously
treated)
Effect levels (P1)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 ppm (nominal)
- Sex:
- not specified
- Basis for effect level:
- other: See remark
- Dose descriptor:
- NOEL
- Effect level:
- >= 3 000 - <= 10 000 ppm (nominal)
- Sex:
- not specified
- Basis for effect level:
- other: See remark
- Remarks on result:
- other: other: other: Generation: F1a, F2b (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- 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)
any of the generations. Viability index slightly depressed in F1a litters of females at highest dose level. In all other groups, the viability index was
comparable to the control group. Body weight gain was slightly depressed in the F1a, F1b, F2a and F2b litters. All other treated offspring gained
weight at similar rate to the controls.Significant inter-group variations were not observed.
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- >= 10 000 ppm (nominal)
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- >= 10 000 ppm
- Sex:
- not specified
- Basis for effect level:
- other: embryotoxicity
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL with regard to reproductive performance and/or embryotoxicity was 10000 ppm in the diet (corresponding to about 500 - 675 mg/kg
body weight per day). - Executive summary:
The influence of sec-alkane sulfonate-sodium salts SAS (60%) upon reproductive function and fertility was assessed over two generations in rats of the Charles River CD strain. For this purpose, sec-alkane sulfonate-sodium salts SAS was administered in the diet to both the F0and F1generations at levels of 1000, 3000 or 10000 ppm. Treatment was given either continuously to both sexes for 60 days prior to mating and throughout three successive pregnancies (F1A, F1B, F1C, F2A, F2B and F2C) or to females only during the organogenesis stage of three successive pregnancies. Animals were randomly selected from the F1B litters to form the second generation. In both the F0and F1generations, haematological investigations were carried out after 60 days of treatment on five males and five females in each group, prior to carbon dioxide asphyxiation and subsequent macroscopic and histopathological examination. The remaining animals were paired, within groups, on a one to one basis on three consecutive occasions. After the first two matings (F1A, F1B, F2A, F2B) the females were allowed to litter naturally and rear their young to weaning. Following the third mating (F1C, F2C) half of the dams in each group were killed on day 13 of gestation, and the remainder were killed on day 21 of gestation, to permit examination of their uterine contents. After termination of each generation, all parent animals were examined macroscopically. Five males and five females from each of the continuously treated groups, together with five females only from each of the groups treated during organogenesis, were randomly selected for histopathological evaluation. In both generations prior to mating, food intake, haematological parameters, absolute and relative organweights and histopathological evaluation of tissues showed no adverse treatment-related effects.In the F0generation, a slight but not statistical significant depression of body weight gain was observed in males treated continuously with sec-alkane sulfonate-sodium salts SAS at 10000 ppm. A similar reduction was observed in F0females treated prior to mating at 10000 ppm and statistical significance was achieved here in week 8 of treatment. During the three subsequent pregnancies, some fluctuation in body weight gain was recorded in treated females, but no significant inter-group variation was observed. In both generations, oestrous cycles, mating performance and conception rates were unaffectedby treatment. In the F0and F1generation no alterations in duration of gestation were observed. Neither generation, during the first two pregnancies (F1A, F1B, F2A, F2B), showed any treatment-related effects in the number of litters containing at least one viable young, the litter size at birth, or the live birth index. The viability index was significantly depressedin the F1A litters of females receiving 3000 or 10000 ppm continuously, and in the F2B litters of the females receiving 3000 ppm continuously. In all other groups, the viability index was comparable with that of the control group. The body weight of offspring at day 1 post partum showed no significant inter-group variations. However, the bodies weight gain of offspring from females receiving 10000 ppm continuously was depressed in the F1A, F1B, F2A and F2B litters. All other treated offspring gained weight at a similar rate to the controls. In both generations, the sex ratio at day 4 post partum and the weaning were unaffected by treatment. Macroscopic examination, absolute and relative organ weights and histopathological evaluation of F0and F1parent animals showed no adverse treatment-related effects. It was concluded from these investigations that continuous treatment with sec-alkane sulfonate-sodium salts SAS at a level of 10000 ppm gave rise to a slight depression of somatic growth in parent animals and offspring in both generations, and to a marginal interference with survival of F1A offspring. At the intermediate dose level of continuous treatment (3000 ppm) slight depression of somatic growth of F1males was observed and there was marginal interference with survival of F1A and F2B offspring. At the lowest level of continuous treatment as well as in animals treated at all levels during organogenesis, no treatment-related adverse effects were observed. There were no indications for an embryotoxic or teratogenic effect related to treatment in any dose groups.
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