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EC number: 947-427-7 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Reproduction/Developmental Toxicity Screening Test (gavage), rat (Sprague-Dawley) m/f (OECD guideline 421, GLP not specified (publication)): NOAEL: 1000 mg/kg bw/day (nominal) (male/female)
Read-across from Alkylpolyglucoside C12-14 fatty alcohol
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 27th July 1995
- GLP compliance:
- not specified
- Limit test:
- yes
- Specific details on test material used for the study:
- Limited details on test substance might also be described as D-Glucopyranose, Oligomeric, C10-16 Alkyl Glycosides
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no information
- Age at study initiation: no information
- Weight at study initiation: no information
- Fasting period before study: no information
- Housing: 5 animals per sex per cage
- Diet: ad libitum (commercially available laboratory rodent diet)
- Water: ad libitum
- Acclimation period: no information
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C (+/- 2°C)
- Humidity: 55 % (+/-10 %)
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: no information
- Length of cohabitation: nop information
- Proof of pregnancy: vaginal plug / sperm in vaginal smear
- Further matings after two unsuccessful attempts: no information - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Prior to mating, throughout the gestation (22 days) and lactation period until post mortem day 3.
- Details on study schedule:
- - Age at mating of the mated animals in the study: 14 weeks
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control group
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
OTHER: Effects related to reproduction and hormone balance such as estrous cycle, mating performance, pregnancy rates and the number of embryo resorptions are registered. Pup losses are recorded and the filial generation is examined for behavioural abnormalities and external growth abnormalities. - Oestrous cyclicity (parental animals):
- Estrous cycle was monitored.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
testis weight, epididymis weight - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- No adverse effects were observed in all test animals at all doses, the highest dose being 1000 mg/kg/d.
- Executive summary:
The reproductive toxicity of the substance was assessed in a an OECD 421 reproductive screening study. Sprague-Dawley rats were randomly assigned to four groups the animals of which were administered with the substance by gavage with 0, 100, 300 and 1000 mg/kg/d. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post mortem).
No effects indicative of general toxicity are observed in parental animals. Relative and absolute weights of testes, epididymides, and seminal vesicles do not differ between test substance and control animals. A marginal reduction is seen in absolute and relative prostate weights in all treated males compared to the control group. A significant difference is found for the low dose group only and no dosedependency was found. Therefore, this finding is not considered to be substance related. With regard to reproductive parameters, no test substance related symptoms are observed. One female in the mid-dose group and two females in the high-dose group did not mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days. Mean litter weights, mean pup weights, sex ratios and gestation periods are similar among all groups. Some slight variations in pre-birth loss are seen in the high-dose group although no significant differences to the controls is found. Clinical signs do not show treatment related effects on pre-weaning pups nor do necropsy reveal any effects in decedent or Fl pups. There is no difference between treated and control animals as assessed by macroscopic examination. No adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day. So a NOEL of 1000 mg/kg/day can be established.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The reproductive toxicity of Alkylpolyglucoside C12-14 fatty alcohol was assessed in an OECD 421 reproductive screening study. Sprague-Dawley rats were randomly assigned to four groups the animals of which were administered with the substance by gavage with 0, 100, 300 and 1000 mg/kg/d. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post mortem).
No effects indicative of general toxicity are observed in parental animals. Relative and absolute weights of testes, epididymides, and seminal vesicles do not differ between test substance and control animals. A marginal reduction is seen in absolute and relative prostate weights in all treated males compared to the control group. A significant difference is found for the low dose group only and no dosedependency was found. Therefore, this finding is not considered to be substance related. With regard to reproductive parameters, no test substance related symptoms are observed. One female in the mid-dose group and two females in the high-dose group did not mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days. Mean litter weights, mean pup weights, sex ratios and gestation periods are similar among all groups. Some slight variations in pre-birth loss are seen in the high-dose group although no significant differences to the controls is found. Clinical signs do not show treatment related effects on pre-weaning pups nor do necropsy reveal any effects in decedent or Fl pups. There is no difference between treated and control animals as assessed by macroscopic examination. No adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day. So a NOEL of 1000 mg/kg/day can be established.
The main difference between source and target substance is the alkyl chain distribution. The justification for read-across is given in the target record.
There is supporting information available on toxicity for reproduction of long chain aliphatic alcohols (C6 - C22). Fertility assays did not reveal any adverse reproductive effects. Furthermore, there was no evidence indicative of adverse changes in the reproductive organs in a number of repeated dose studies. Overall, there are no concerns that the category of long chain alcohols might adversely affect fertility. The available data for developmental toxicity for the category long chain alcohols (LCOH) as a whole does not raise any indication of adverse developmental effects including clearly negative developmental toxicity studies based on studies with rats for C5 alcohol, 1-hexanol, C7–C11 alcohols, and 1-octanol (Hellwig and Jäckh, 1997; Klimisch and Hellwig,1995) (from Veenstra et al. 2009).
Taking this supporting information into account, the NOAEL of 1000 mg/kg bw/day as derived for the source substance in a reproduction/developmental screening test in rats can be considered to represent a worst case.
Although, it must be noted that a reproductive/developmental toxicity screening study alone is not suitable to exclude for sure the presence of toxic effects to reproduction if the result is negative, together with the results of the subchronic toxicity investigations (no effects on male or female reproductive organs), it can be concluded that alkyl polyglycosides are substances of no concern with regard to toxicity to reproduction. That conclusion is further supported by the common metabolic fate, resulting in the formation of the physiologically occurring metabolites sugar and fatty acids, which are also part of our daily nutrition and of no toxicological concern.
Therefore, based on the considerations above, it can be concluded that the results of the oral reproduction/developmental screening study conducted in the rat with the source substance are likely to predict the properties of the target substance and are considered as adequate to fulfil the information requirement of Annex IX, 8.7.2. The dose descriptor obtained from the existing reproduction/developmental screening study performed on the source substance is considered as an appropriate starting point for deriving a DNEL.
No reproductive toxicity is expected to occur after repeated oral exposure to D-Glucose, reaction products with alcohols C16-18 (even numbered). Thus, the NOAEL is considered to be ≥1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
Reproduction/Developmental Toxicity Screening Test (gavage), rat (Sprague-Dawley) m/f (OECD guideline 421, GLP not specified (publication)): NOAEL: 1000 mg/kg bw/day (nominal) (male/female)
Read-across from Alkylpolyglucoside C12-14 fatty alcohol
Justification for classification or non-classification
Based on the available relevant and reliable data, D-Glucose, reaction products with alcohols C16-18 (even numbered) does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008.
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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