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Diss Factsheets
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EC number: 939-523-2 | CAS number: 1471312-55-6
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 68891-38-3 (purity 27%)
- IUPAC Name:
- 68891-38-3 (purity 27%)
- Details on test material:
- - Name of test material (as cited in study report): Trade name
- Ethoxylation degree: No data
- Physical state: Aqueous solution
- Analytical purity: 27% a.i.
- Lot/batch No.: 103/96
- Storage Condition of test material: At RT in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- The test article was formulated for dosing as solutions in the vehicle, purified drinking water. For formulation, the weighed quantity of test article was mixed with the appropriate volume of vehicle. Separate formulations were prepared for each dose level. Formulations were prepared once weekly and stored in polycarbonate aspirators at ambient temperature in the animal room during the week of use.
- Details on mating procedure:
- According to Guideline.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males: 11 weeks before mating; during mating, until necropsy.
Females: 2 weeks before mating; during mating, pregnancy and lactation, until necropsy (Day 21 post partum).
(F1 generation was dosed from birth.) - Frequency of treatment:
- N.a.
- Details on study schedule:
- F1 parental animals were mated 16 weeks after selected from the F1 litters.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
(0.03, 0.1, 0.3%) 30, 100, 300 mg/kg bw
Basis:
other: Roughly calculated by test article intake.
- No. of animals per sex per dose:
- 30 (F0 gen), 25 (F1 gen)
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- According to Guideline.
- Oestrous cyclicity (parental animals):
- According to Guideline.
- Sperm parameters (parental animals):
- According to Guideline.
- Litter observations:
- According to Guideline.
- Postmortem examinations (parental animals):
- According to Guideline.
- Postmortem examinations (offspring):
- According to Guideline.
- Statistics:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
(Transient) reductions were considered to be related to the palatability of the drinking water.
BIOCHEMISTRY:
Reduced triglyceride levels (female).
SPERM MEASURES:
Reduced straight line velocity of the sperm at 0.3%.
ORGAN WEIGHTS:
The male F0 generation showed a small but significant reduction in body weight-liver weight ratios, but the corresponding brain related liver weights and the absolute liver weights developed not in a dose dependant way. For the F1 generation where similar results were reported, no dose-response relationship was detected either. No influence on liver weight development was seen in the F2 generation. None of the groups revealed any histopathological or clinical-chemical findings, which could be attributed to hepatotoxicity. This led to the conclusion that this untypical liver weight reduction was of no toxicological relevance, additionally underlined by the absence of such effects in the studies for subchronic toxicity mentioned above.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- > 300 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Remarks on result:
- other: Generation: P and F1 (migrated information)
- Dose descriptor:
- NOEL
- Remarks:
- reproduction
- Effect level:
- > 300 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Remarks on result:
- other: Generation: P and F1 (migrated information)
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:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
(Transient) reductions were considered to be related to the palatability of the drinking water.
BIOCHEMISTRY:
Increased percentage neutrophil counts (males).
SEXUAL MATURATION:
Increase in time at females dosed at 0.3%.
ORGAN WEIGHTS:
see 'parental animals'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Slight but significantly reduced straight line velocity (VSL) of the sperm was without any significant effects on averaged path velocity (VAP) or total motility. Moreover, in the available subchronic and chronic toxicity studies on various AES the primary sex organs of the males and females did not show evidence for treatment-related adverse effects.The observed reduced triglyceride levels (female) and increased percentage neutrophil counts (males) were slight and within the range of the historical control data.
The male F0 generation showed a small but significant reduction in bodyweight-liver weight ratios, but the corresponding brain related liver weights and the absolute liver weights developed not in a dose dependant way. For the F1 generation where similar results were reported, no dose-response relationship was detected either. No influence on liver weight development was seen in the F2 generation. None of the groups revealed any histopathological or clinical-chemical findings, which could be attributed to hepatotoxicity. This led to the conclusion that this untypical liver weight reduction was of no toxicological relevance, additionally underlined by the absence of such effects in the studies for subchronic toxicity mentioned above.
There was evidence of toxicity on pup development at this dose level that was characterised by an increase in the time taken for sexual development of the male (not significant) and female (significant) offspring.This was investigated in more detail in the developmental toxicity study up to 1.5 g/kg bw and no effects were noted there.
Considering all these facts the subchronic NOAEL for systemic toxicity can be set to greater than 300 mg/kg bw.
Applicant's summary and conclusion
- Conclusions:
- In summary, there was no effect of treatment at any dose level on reproduction of the parents or offspring (NOAEL > 0.3 %; > 300 mg/kg/day).
Based on this study an overall NOAEL for systemic effects of 0.3 % (300 mg/kg bw) can be deduced.
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