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EC number: 604-638-6 | CAS number: 148520-82-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No reproductive toxicity data with the target substance is available . Data generated with the supporting substance LABS Na is used to cover this endpoint. LABS Na was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw.
Link to relevant study records
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented peer-reviewed publication.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- LABS Na (chain length distribution C10-14) was fed for 84 days to 4 groups of weanling rats (3 dose levels, plus control), each dose consisting of 50 animals each of both sexes (P0-generation). When the P0 generation was 107-112 days old, 20 females from each dose group were mated with 20 males from the same group and maintained together for 17 days. The first litters of each generation (Fla- and F2a-generation) were sacrificed at 21 days of age. Ten days after the final litter was sacrificed, all females were remated with different males from the same group to obtain the F1b generation. From the Flb-generation, 20 males and females of each group were selected at weaning to continue their respective diets and to be used for further reproduction studies. Reproduction studies on the F1b and F2b generations were started when the rats were 80 to 85 days old, and were continued until the F3b generation was weaned.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- Na-LAS (chain length distribution C10-14)
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: (P) weanling; (F1) 21 days
- Weight at study initiation: (P) Males: average 59.4-59.9 g; Females: average 57.0-57.3 g; (F1) Males: group weight 183.5-214.2 g; Females: group weight 157.8-193.2 g
- Housing: individual wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 76 +/- 3
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs
: - Route of administration:
- oral: feed
- Vehicle:
- other: LAS was administered in feed (Purina Laboratory Meal) - no documentation of dilution prior to addition to meal
- Details on mating procedure:
- premating exposure period 84 days
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 years ( 3 generations)
- Frequency of treatment:
- continuous in feed
- Details on study schedule:
- - F1 parental animals not mated until 80-85 days old
- Selection of parents from F1 generation when pups were 21 days of age.
- Age at mating of the mated animals in the study: 107-112 days old - Dose / conc.:
- 14 mg/kg bw/day
- Remarks:
- 0.02 %, actual ingested
- Dose / conc.:
- 70 mg/kg bw/day
- Remarks:
- 0.1%, actual ingested
- Dose / conc.:
- 350 mg/kg bw/day
- Remarks:
- 0.5%, actual ingested
- No. of animals per sex per dose:
- 50 males and 50 females per group.
- Control animals:
- yes, concurrent no treatment
- Litter observations:
- Deformities and number of pups, average body weights, feed consumption, feed efficiency.
- Postmortem examinations (parental animals):
- Necropsy, body weight, organ to body weight ratios, routine hematology and histology.
- Postmortem examinations (offspring):
- Necropsy, body weight, organ to body weight ratios, routine hematology and histology.
- Reproductive indices:
- fertility, gestation, parturition, neonatal viability, lactation, and post-weaning growth
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no effects to body weight were noted in the initial twelve weeks
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- no effects to body weight were noted in the initial twelve weeks
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: no effects to average food consumption were noted in the initial twelve weeks
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- not specified
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 350 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- No significant effects on reproduction were observed at the highest concentration tested.
- Executive summary:
LABS Na was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%)
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 350 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
No developmental toxicity study with the target substance is available. Data generated with the supporting substance LABS Na was used to cover this endpoint. In a first developmental toxicity study (performed equivalent to OECD guideline 414) with oral dosing via drinking water, the NOAEL for both maternal toxicity and teratogenicity was set at 300 mg/kg. In a second developmental toxicity study, pregnant female mice were exposed to LABS Na via gavage on days 6 -15 of gestation. The NOAEL for teratogenicity was 300 mg/kg bw/day; the NOAEL for maternal toxicity was 2 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No developmental toxicity study with the target substance is available. Data generated with the supporting substance LABS Na was used to cover this endpoint.
In a first developmental study, female rats were given LABS Na orally in distilled water from gestation days 6 to 15 during pregnancy. Some effects such as decreased weight gain and transient diarrhea occurred at the highest dose. Pregnancy rates were comparable at all doses. Litter parameters were not significantly affected at any dose. No significant differences were observed in visceral anomalies or skeletal variants, with the exception of a marginal retardation of sternabral ossification at the highest dose. NOAEL was set at 300 mg/kg for both maternal and teratogenicity.
In a second developmental study, pregnant female mice were exposed to LABS Na via gavage on days 6 -15 of gestation (doses 2, 300, 600 mg/kg bw/d). Increased mortality was observed at the two highest doses (300 and 600 mg/kg bw/day). These doses also exhibited retarded weight gain and adverse signs in the necropsy. Pregnancy was comparable, however, for all groups. At doses without maternal toxicity, no differences were observed in any parameters. Because of the very wide range between the 2 mg/kg and 300 mg/kg doses, the maternal NOAEL of 2 mg/kg bw/day must be considered as very conservative and overruled by the NOAEL derived in the 6 months repeated dose study, described above. The NOAEL for teratogenicity was 300 mg/kg bw/day.
Justification for classification or non-classification
Based on the results described, LABS Na is not to be classified as reproductive toxicant.
Additional information
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.
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