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EC number: 931-219-8 | 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
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2011 to September 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and audited
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Margate, UK
- Age at study initiation: 10 to 12 weeks old
- Weight at study initiation: Males: 271.2 - 310.4g; Females: 172.1 - 201.7g;
- Fasting period before study: N/A
- Housing: Cages conforming to 'Code of practice for the housing and care of animals used in scientific procedures' (Home Office, London, 1989)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26th January 2010 To: 6th April 2010 - Route of administration:
- oral: gavage
- Vehicle:
- other: MC (methyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: daily
VEHICLE
- Justification for use and choice of vehicle (if other than water): to ensure homogenous suspension of the substance for dosing as it is insoluble in water
- Amount of vehicle (if gavage): 10ml/kg - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 15 days
- Proof of pregnancy: vaginal plug / sperm in vaginal washing referred to as day 0 of pregnancy
- After 10 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: individually
- Any other deviations from standard protocol: none - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Verification of composition at start and end of sampling carried out by XRF analysis, concentrations verified by gravimetric analysis of start and end samples.
- Duration of treatment / exposure:
- 40 days to 55 days
- Frequency of treatment:
- daily dosing
- Remarks:
- Doses / Concentrations:
250mg/kg/day
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
25mg/kg/day
Basis:
nominal conc. - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: The dose level for the test article was chosen after consultation with the Sponsor and based on the results of previous gavage studies on similar test articles and the physical properties of the test articles. Due to the potential risk of physical interference with gut motility, a high dose of between 50 and 100 mg/rat/day (250 mg/kg/day) was considered to be the limiting dose for this study.
A second dose of 25 mg/kg/day was adminstered to a second group of rats - Positive control:
- none used
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily start and end (nominal) of the working day In addition, the animals were observed immediately on return to the home cage after dosing and at 0.5, 1, 2 and 4 hours post dose for signs of reaction to treatment for the first two weeks of dosing. As no signs were observed the animals were observed immediately on return to the home cage after dosing and at 0.5 and 1 hour post dose only from the start of the pairing period until the end of dosing.
- Cage side observations checked; ill health or overt toxicity. Any abnormalities of appearance or behaviour or other signs of reaction to treatment or ill health were recorded
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly, at time of body weight examination Clinical signs for females during the gestation and lactation periods, were recorded more frequently that weekly due to days of body weight recording.
BODY WEIGHT: Yes
- Time schedule for examinations:
MALES : Day -7 (randomisation body weight check)
Weekly
Day of (prior to) necropsy
FEMALES: Day -7 (randomisation body weight check)
Weekly prior to pairing and until confirmation of mating
Days 0, 7, 14 and 20 of gestation
Days 1 and 4 post partum
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
The food consumed by each cage of animals was determined weekly during the pre pairing periods.
Individual food intake of mated females was recorded on Days 0 to 6, 7 to 13 and 14 to 19 of gestation, and on Days 1 to 3 of lactation. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in offspring:
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other:]
GROSS EXAMINATION OF DEAD PUPS:
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
- Male animals: All surviving animals after assessment of females and offspring
- Maternal animals: All surviving animals 5 days post-partum
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations, including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues listed below were prepared for microscopic examination and weighed, respectively.
ovaries (with oviducts) testes
uterus epididymides
cervix seminal vesicles
vagina prostate
pituitary coagulating gland
gross lesions animal identification - Postmortem examinations (offspring):
- SACRIFICE
- The offspring were sacrificed at 5 days of age.
- These animals were subjected to postmortem examinations (macroscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Statistics:
- Statistical analysis used SAS
- Reproductive indices:
- Mating Index
Female fecundity index
Male fecundity index
Female fertility index
Male fertility index
Median pre-coital time - Offspring viability indices:
- Post implantation survival index
Viability index 1
Gestation index - 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- Reproductive effects observed:
- not specified
- Conclusions:
- Administration of Superwool 1400 by oral gavage to male rats for at least 55 days and to female rats for at least 41 days at 250 mg/kg/day elicited no signs of adverse toxicity.
The no observed adverse effect level (NOAEL) for reproductive and developmental toxicity was considered to be at least 250 mg/kg/day for Superwool 1400 - Executive summary:
The objective of the study was to provide a preliminary evaluation of the effects of
the test article, Superwool 1400, on the reproductive/developmental toxicity in the rat.
Groups of 10 male and 10 female rats were given 25 or 250 mg/kg/day of
Superwool 1400 orally, by gavage, for two weeks prior to pairing, during the pairing
period and until Day 4 post-partum for the females and until the day before necropsy
in Week 8 for the males. A similar group of 10 males and 10 females were given
1% (w/v) methylcellulose over the same period to act as controls.
There was one death during the study; the cause of demise was a gavage injury, and
not related to Superwool 1400 administration.
There were no clinical observations recorded that were considered to be related to
administration with Superwool 1400.
Mean body weight gains and food intake were unaffected by administration with
Superwool 1400.
Mating data were unaffected by Superwool 1400 administration and there was no
effect on mean uterine/implantation data or mean litter data.
Mean organ weights were unaffected by Superwool 1400 administration. At necropsy,
macroscopic findings were unremarkable.
There were no microscopic findings or findings in the testis, suggestive of effects due
to Superwool 1400 administration.
In conclusion, administration of Superwool 1400 by oral gavage to male rats for at
least 54 days and to female rats for at least 41 days at 25 or 250 mg/kg/day elicited no
signs of adverse toxicity.
The no-observed-adverse-effect-level (NOAEL) for reproductive and developmental
toxicity was considered to be at least 250 mg/kg/day.
Reference
There was one death during the study; the cause of demise was a gavage injury, and not related to Superwool 1400 administration.
There were no clinical observations recorded that were considered to be related to administration with Superwool 1400.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
There was no adverse effect of treatment on mean body weight or body weight gain in males or females. In males and females, there was no effect of treatment on mean food intake.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
the majority of females mated within one oestrous cycle.
There was no effect of treatment on fertility or fecundity indices
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
Qualitative testis staging did not indicate any abnormalities in the integrity of the various cell types present within the different stages of the spermatogenic cycle.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
There was no effect of treatment on mating, the majority of females mated within one oestrous cycle.
There was no effect of treatment on fertility or fecundity indices.
ORGAN WEIGHTS (PARENTAL ANIMALS)
There was no adverse effect of treatment on adult male or female organ weights.
GROSS PATHOLOGY (PARENTAL ANIMALS)
there was no effect of treatment on adult male or females
HISTOPATHOLOGY (PARENTAL ANIMALS)
Macroscopic findings
Most tissues were macroscopically unremarkable and the findings seen were generally consistent with the usual pattern of findings in rats of this strain and age. There were no macroscopic findings suggestive of effects of the test articles.
Microscopic findings
Microscopic findings were generally infrequent, of a minor nature and consistent with the usual pattern of findings in rats of this strain and age. There were no microscopic findings in treated animals due to effects of the test articles.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
No effects on fertility were observed in the OECD 421 screening test.
Justification for selection of Effect on fertility via oral route:
Screening study carried out on substance to be registered
Effects on developmental toxicity
Description of key information
No evidence of adverse effects to development of offspring were observed in the OECD 421 screening study.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Justification for classification or non-classification
no adverse effects were observed in the reproductive toxicity study (OECD 421) carried out by oral dosing for this substance.
Additional information
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