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EC number: 271-591-2 | CAS number: 68585-82-0
- 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
A combined repeated dose oral toxicity study with a reproduction/ developmental toxicity screening performed with substance analogue Yttrium Oxide is available. Based on this study, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be >=1000 mg/kg body weight. No adverse effects on fertility were observed. This result is read across to yttrium oxide, europium doped.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The rationale to read across the data is attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no clinical signs recorded in male and female animals of treated groups that could be directly related to treatment. However, there were few clinical signs namely moving the bedding, nasal discharge (dark or reddish), salivation and piloerection seen occasionally and transiently during the study period in MD or HD group animals. These findings were considered to be due to local effect but not the systemic effect of the test item. These findings were considered not likely to be adverse. In addition, there was alopecia (on hind limb, forelimb, thorax and abdominal region) of few isolated animals of MD or HD groups, which was assumed to be incidental in origin. During the weekly detailed clinical observation, no significant changes or differences between the groups were found.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In both males and females, no treatment related changes were noted for body weight and body weight change during the study period. Statistically there were significant increase in body weight change in female HD group during 2nd week of premating period when compared to control. In addition, there was lower mean body weight gain noted between days 1-7 of premating when compared to control without attaining the statistical significance. But, this increase or decrease in weight gain did not correlate with food intake during the same period. Hence, the changes were not considered likely to be adverse. There was decrease in body weight gain noted in female MD and HD groups during lactation period when compared to control. This decrease had no statistical significance and was not likely to be adverse.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no ophthalmoscopic findings in any of the animals of this study.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- For details see 7.5.1.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- For details see 7.5.1.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No relevant effects of treatment were observed in any of the parameters of the functional observation battery before and at the end of the treatment period. There were no biologically relevant differences in body temperature between the groups.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- For details see 7.5.1.
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- There were no treatment related changes noted for epididymal sperm motility (Motile Count %, Static Count % and Rapid Count %) measured in all animals of treated and control groups. The statistical analysis of epididymal sperm motility indicated no statistical significant difference between the treated and control groups.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were noted for number of corpora lutea, number of implantation sites, number of live pups born on PND 0 and percentage of pre and post implantation loss in treated groups when compared to control. The statistical evaluation of data revealed no significant differences between the values of treated and control groups.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects seen at highest test dose
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were noted for survival of the pups from PND 0 to PND 4 in treated groups when compared to control.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- One pup each in Control, LD and MD groups found dead or missing between PND 0 and 4. The missing pup was assumed to be cannibalized by the dam, this observation was considered to be incidental. No treatment related changes were considered for viability index (%).
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related gross external findings were observed in any of the treated groups. However, there were few isolated findings noted in pups namely dry skin, dark spot on/ or dark abdomen, dark snout in control group; dark spot on forelimb and thoracic back, dark snout in LD group; dry skin in MD and HD groups. These findings were considered to be incidental in origin.
- Histopathological findings:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects seen at highest dose tested
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Repeated dose administration of Yttrium Oxide to male (minimum 28 days) and female (maximum 54 days) Wistar rats following OECD guideline 422 at dosages of 100, 300 and 1000 mg/kg body weight revealed neither mortalities nor findings of toxicological relevance in male and female animals. There were also no toxicologically relevant findings noted for reproductive and developmental parameters.
Based on these data, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be 1000 mg/kg body weight/day. The NOEL for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day. This result is read across to Yttrium oxide, europium-doped. - Executive summary:
A repeated dose study was performed according to OECD guideline 422 with Yttrium Oxide. Male (minimum 28 days) and female (maximum 54 days) Wistar rats were dosed at dosages of 100, 300 and 1000 mg/kg body weight/day. There were no changes considered to be related to treatment noted for organ weight in both males and females when compared to corresponding control. However, there was statistically significant increase in relative weight of left kidney weight in male treated (LD, MD and HD) groups, but not total kidney weight. This change in left kidney weight, in the absence of histological changes was not considered to have toxicological relevance.
No test item-related effects were noted on male and female reproductive organs in any of the treatment groups. The statistical analysis of epididymal sperm motility indicated no statistical significant difference between the treated and control groups. No treatment related changes were noted for the precoital interval and duration of gestation in treated groups when compared to control. All pregnancies resulted in normal births.
There were no treatment related changes noted for copulation index (%), fertility index (%), delivery index (%) and viability index (%) in treated groups when compared to corresponding control group.
Successful mating resulted 100% pregnancy rates in C and HD groups and 90% pregnancy rates in LD and MD groups. Histologically, they showed physiological sexual cycling, and their unsuccessful mating was considered unrelated to the treatment. The statistical evaluation of pre and post-natal data revealed no significant differences between the values of treated and control groups. No treatment related no significant changes were noted for survival of the pups and for viability index (%).
Based on these data, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be >=1000 mg/kg body weight/day. The NOEL for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day. This result is read across to Yttrium oxide, europium-doped.
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
- Quality of whole database:
- Klimisch 1 study (performed with substance analogue).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No study with yttrium oxide, europium doped is available. However, a study with yttrium oxide is present. The justification for this analogue approach is described in a report (see section 13 of IUCLID).
An OECD 422 study according to GLP
principles was performed with rats. Yttrium
oxide was administered daily by oral gavage to male and female Wistar
rats,7 days per week with a
maximum exposure of 54 days in total for females (at least 14 days of
pre-mating, maximum 14 days of mating, 22 days of gestation and 4 days
of post-partum) and minimum 28 days for males.,
at dose-levels of 100, 300 or 1000 mg/kg/day. There
were no adverse effects of treatment on tested Wistar rats at any
dose-level on mortality, clinical signs and biochemistry, body weight or
food consumption. There
were no effects in any group on mating, fertility or delivery and no
treatment-related effects on the mean numbers of corpora lutea,
implantations or pups. There were no effects on mean pup body weight or
survival. There were no treatment-related organ weights and macroscopic
changes in rats treated even at 1000 mg/kg/day. There were
no treatment related changes noted for copulation index (%), fertility
index (%), delivery index (%) and viability index (%) in treated groups
when compared to corresponding control group. Successful mating resulted
100% pregnancy rates in C and HD groups and 90% pregnancy rates in LD
and MD groups. One female of LD group and one female of MD group were
found not to be pregnant at terminal sacrifice. Histologically, they
showed physiological sexual cycling, and their unsuccessful mating was
considered unrelated to the treatment. Based
on this the NOAEL for systemic and reproductive and developmental
toxicity is considered to be >= 1000 mg/kg body weight.
Effects on developmental toxicity
Description of key information
A combined repeated dose oral toxicity study with a reproduction/ developmental toxicity screening performed with substance analogue Yttrium Oxide is available. Based on this study, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be >=1000 mg/kg body weight. This result is read across to yttrium oxide, europium doped.A combined repeated dose oral toxicity study with a reproduction/ developmental toxicity screening performed with substance analogue Yttrium Oxide is available. Based on this study, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be 1000 mg/kg body weight. This result is read across to yttrium oxide, europium doped.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Remarks:
- screening study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The rationale to read across the data is attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no clinical signs recorded in male and female animals of treated groups that could be directly related to treatment. However, there were few clinical signs namely moving the bedding, nasal discharge (dark or reddish), salivation and piloerection seen occasionally and transiently during the study period in MD or HD group animals. These findings were considered to be due to local effect but not the systemic effect of the test item. These findings were considered not likely to be adverse. In addition, there was alopecia (on hind limb, forelimb, thorax and abdominal region) of few isolated animals of MD or HD groups, which was assumed to be incidental in origin.
During the weekly detailed clinical observation, no significant changes or differences between the groups were found. - Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In both males and females, no treatment related changes were noted for body weight and body weight change during the study period. Statistically there were significant increase in body weight change in female HD group during 2nd week of premating period when compared to control. In addition, there was lower mean body weight gain noted between days 1-7 of premating when compared to control without attaining the statistical significance. But, this increase or decrease in weight gain did not correlate with food intake during the same period. Hence, the changes were not considered likely to be adverse. There was decrease in body weight gain noted in female MD and HD groups during lactation period when compared to control. This decrease had no statistical significance and was not likely to be adverse.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no ophthalmoscopic findings in any of the animals of this study.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No relevant effects of treatment were observed in any of the parameters of the functional observation battery before and at the end of the treatment period. There were no biologically relevant differences in body temperature between the groups.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were noted for number of corpora lutea, number of implantation sites, number of live pups born on PND 0 and percentage of pre and post implantation loss in treated groups when compared to control. The statistical evaluation of data revealed no significant differences between the values of treated and control groups.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were noted for survival of the pups from PND 0 to PND 4 in treated groups when compared to control. However, there was 1 pup each in Control (Pup no. 3; animal 50), LD (Pup no. 12, animal 58) and MD (Pup no. 9, animal 70) groups found dead or missing between PND 0 and 4. The missing pup was assumed to be cannibalized by dam, which was considered to be incidental. No treatment related changes were considered for viability index (%).
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment related gross external findings were observed in any of the treated groups. However, there were few isolated findings noted in pups namely dry skin, dark spot on/ or dark abdomen, dark snout in control group; dark spot on forelimb and thoracic back, dark snout in LD group; dry skin in MD and HD groups. These findings were considered to be incidental in origin.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects seen at highest dose tested
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Repeated dose administration of Yttrium Oxide to male (minimum 28 days) and female (maximum 54 days) Wistar rats following OECD guideline 422 at dosages of 100, 300 and 1000 mg/kg body weight revealed neither mortalities nor findings of toxicological relevance in male and female animals. There were also no toxicologically relevant findings noted for reproductive and developmental parameters.
Based on these data, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be 1000 mg/kg body weight/day. The NOEL for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day. This result is read across to Yttrium oxide, europium-doped. - Executive summary:
A repeated dose study was performed according to OECD guideline 422 with Yttrium Oxide. Male (minimum 28 days) and female (maximum 54 days) Wistar rats were dosed at dosages of 100, 300 and 1000 mg/kg body weight/day. There were no changes considered to be related to treatment noted for organ weight in both males and females when compared to corresponding control. However, there was statistically significant increase in relative weight of left kidney weight in male treated (LD, MD and HD) groups, but not total kidney weight. This change in left kidney weight, in the absence of histological changes was not considered to have toxicological relevance.
No test item-related effects were noted on male and female reproductive organs in any of the treatment groups. The statistical analysis of epididymal sperm motility indicated no statistical significant difference between the treated and control groups. No treatment related changes were noted for the precoital interval and duration of gestation in treated groups when compared to control. All pregnancies resulted in normal births.
There were no treatment related changes noted for copulation index (%), fertility index (%), delivery index (%) and viability index (%) in treated groups when compared to corresponding control group.
Successful mating resulted 100% pregnancy rates in C and HD groups and 90% pregnancy rates in LD and MD groups. Histologically, they showed physiological sexual cycling, and their unsuccessful mating was considered unrelated to the treatment. The statistical evaluation of pre and post-natal data revealed no significant differences between the values of treated and control groups. No treatment related no significant changes were noted for survival of the pups and for viability index (%).
Based on these data, the no observed adverse effect level (NOAEL) for systemic and reproductive and developmental toxicity is considered to be >=1000 mg/kg body weight/day. The NOEL for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day and the NOEL for toxic effects on progeny was 1000 mg/kg/day. This result is read across to Yttrium oxide, europium-doped.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch 1 study (performed with substance analogue)
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 study with yttrium oxide, europium doped is available. However, a study with yttrium oxide is present. The justification for this analogue approach is described in a report (see section 13 of IUCLID).
An OECD 422 study according to GLP
principles was performed with rats. Yttrium
oxide was administered daily by oral gavage to male and female Wistar
rats,7 days per week with a
maximum exposure of 54 days in total for females (at least 14 days of
pre-mating, maximum 14 days of mating, 22 days of gestation and 4 days
of post-partum) and minimum 28 days for males.,
at dose-levels of 100, 300 or 1000 mg/kg/day.There
were no adverse effects of treatment on tested Wistar rats at any
dose-level on mortality, clinical signs and biochemistry, body weight or
food consumption.There
were no effects in any group on mating, fertility or delivery and no
treatment-related effects on the mean numbers of corpora lutea,
implantations or pups. There were no effects on mean pup body weight or
survival. There were no treatment-related organ weights and macroscopic
changes in rats treated even at 1000 mg/kg/day.There were no
treatment related changes noted for copulation index (%), fertility
index (%), delivery index (%) and viability index (%) in treated groups
when compared to corresponding control group. Successful mating resulted
100% pregnancy rates in C and HD groups and 90% pregnancy rates in LD
and MD groups. One female of LD group and one female of MD group were
found not to be pregnant at terminal sacrifice. Histologically, they
showed physiological sexual cycling, and their unsuccessful mating was
considered unrelated to the treatment.Based
on this the NOAEL for systemic and reproductive and developmental
toxicity is considered to be >= 1000 mg/kg body weight.
Justification for classification or non-classification
Based on the available information, yttrium oxide, europium doped does not have to be classified for reproduction toxicity according to CLP Regulation (EC) No. 1272/2008 including its amendments.
Additional information
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