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Diss Factsheets
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EC number: 700-834-1 | CAS number: 9041-08-1
- 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
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary. Not GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The Sprague-Dawley rats were used in this fertility and reproductive study. The test substance was administered into dorsal region by subcutaneous route. 10 males and 20 females were treated 60 and 14 days, respectively, before mating with each dose of drug; furthermore females only received the treatment from the first day of pregnancy until the weaning of pups (day 23 after delivery).
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- nonasodium 2-({6-[(2-carboxylato-4-hydroxy-6-{[6-hydroxy-5-(sulfonatoamino)-4-(sulfonatooxy)-2-[(sulfonatooxy)methyl]oxan-3-yl]oxy}-5-(sulfonatooxy)oxan-3-yl)oxy]-4-hydroxy-5-(sulfonatoamino)-2-[(sulfonatooxy)methyl]oxan-3-yl}oxy)-4-hydroxy-3-(sulfonatooxy)-3,4-dihydro-2H-pyran-6-carboxylate
- EC Number:
- 700-834-1
- Cas Number:
- 9041-08-1
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- nonasodium 2-({6-[(2-carboxylato-4-hydroxy-6-{[6-hydroxy-5-(sulfonatoamino)-4-(sulfonatooxy)-2-[(sulfonatooxy)methyl]oxan-3-yl]oxy}-5-(sulfonatooxy)oxan-3-yl)oxy]-4-hydroxy-5-(sulfonatoamino)-2-[(sulfonatooxy)methyl]oxan-3-yl}oxy)-4-hydroxy-3-(sulfonatooxy)-3,4-dihydro-2H-pyran-6-carboxylate
- Details on test material:
- Batch No.: not specified
Purity: not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Female and male 8 weeks of age
- Weight at study initiation: Female and male weighing 200±10 g
- Housing: The animals were housed in Makrolon cages in an air-conditioned room.
- Diet (e.g. ad libitum): Females received pelletted dry diet Altromin MT and males diet Altromin R.
- Water (e.g. ad libitum): Tap water was available ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 55-60%
- Air changes (per hr): Ventilation was 12 times/h
- Photoperiod (hrs dark / hrs light): Lighting schedule was 12:12 light/dark (from 7:00 a.m. to 7:00 p.m.)
No additional data
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Details on exposure:
- The test substance dissolved in physiological solution and administered by s.c. route at 1, 5, 10 mg/kg/d at a volume of 5 mL/kg into the dorsal region.
- Details on mating procedure:
- - M/F ratio per cage: 1/3
- Length of cohabitation: one night
- Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
No additional data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 males and 20 females were treated 60 and 14 days, respectively, before mating with each dose of drug; furthermore females only received the treatment from the first day of pregnancy until the weaning of pups (day 23 after delivery).
- Frequency of treatment:
- Once daily
- Details on study schedule:
- - F1 parental animals not mated until [10] weeks after selected from the F1 litters.
No additional data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 5, 10 mg/kg/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 males and 20 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- None stated
- Positive control:
- None stated
Examinations
- Parental animals: Observations and examinations:
- None stated
- Oestrous cyclicity (parental animals):
- None stated
- Sperm parameters (parental animals):
- None stated
- Litter observations:
- None stated
- Postmortem examinations (parental animals):
- In each dose group half of the females were sacrificed on day 20 of pregnancy, the remaining pregnant animals were allowed to deliver. On sacrifice of pregnant rats, uterus, dead or viable fetuses and resorptions were observed; visceral and skeletal exam of fetuses was carried out.
- Postmortem examinations (offspring):
- After weaning, 20 females were randomly chosen and mated with non-consanguineous males (up to 10 weeks of age).
On day 20 of pregnancy, half of the females of this progeny, were necropsied and uterus and fetuses were examined for implantation sites, including viable, dead and/or resorbed fetuses.
On 10 females of each group dose was recorded the fertility and on day 20 of gestation the animals were sacrificed. - Statistics:
- The results were statistically analyzed by Student's t-test for independent samples.
- Reproductive indices:
- None stated
- Offspring viability indices:
- None stated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: The test substance up to 10 mg/kg by s.c. route did not influence the fertility of parents.
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:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The studies on the fertility and on the reproductive performance in rats, carried out on F0, F1 and F2 progenies, showed that the test substance up to 10 mg/kg by s.c. route did not influence the fertility of parents and the pregnancy of dams; moreover in this study no effects on fetal and peri- and postnatal development of progeny were observed.
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