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EC number: 212-714-1 | CAS number: 853-23-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No reliable, key reproductive toxicity study is available for T008506. Therefore, reliable data from the supporting substance DHEA is used to cover this endpoint. Published data from experimental studies with DHEA are considered. Neonatal treatment of male and female rats with DHEA has adverse effects on the growth and weight of sex organs of both sexes, as well as negatively impacting sexual behaviours (Gotz et al., 1983). It is assumed that the LOAEL is 1mg/day of 4mg/kg/day in rat after subcutaneous administration. The substance is classified as reproductive toxicant cat 1B.
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:
- supporting study
- Justification for type of information:
- Justification of the read-across approach is included in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Conclusions:
- No reliable reproductive toxicity data with the test substance is available. Data from the supporting substance DHEA is used to cover this endpoint. Maternal and fetal toxicity of DHEA is investigated. SD pregnant female rats were divided randomly into 5 gorups, 16 rats per group. The rats in the positive control group received aspirin 300 mg/kg and distilled water was given to rats as the negative control group. Three DHEA groups were treated with 10.4, 20.8 and 41.7 mg/kg. The rats were given DHEA from 7d to 16d pregnant continuously for 10 days, and were sacrificed on 20th day of pregnancy. Adverse effects on pregnant rats and fetuses were assessed. DHEA at 10.4 mg/kg caused miscarriages in pregnant rats. 20.8 and 41.8 mg/kg slowed down the weight increase of mothher and fetuses, and slowed sternum growth. At 41.7 mg/kg visceral abnormality in fetuses increased. All three concentrations of DHEA decreased the number of living fetuses. In conclusion, DHEA had adverse effects in both pregnant rats and fetuses.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- justification of the read-across approach is included in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 4 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: inhibition of growth of testes, seminal vesicles, adrenal glands and pituitary; diminished copulatory activity in males; dose-dependent impairment of cyclicity in females (accompanied by sub- or infertility)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 4 mg/kg bw/day (nominal)
- System:
- male reproductive system
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 4 mg/kg bw/day
- Treatment related:
- yes
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- No reliable, key reproductive toxicity study with T008506 is available. Data from the supporting substance DHEA is used to cover this endpoint.
Neonatal treatment of male and female rats with DHEA has adverse effects on the growth and weight of sex organs in both sexes, as well as negatively impacting sexual behaviours. It is assumed that the LOAEL is 1mg/day or 4 mg/kg/day after subcutaneous administration in rat.
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 4 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- It is assumed that oral administration has equal bioavailaibility as subcutaneous administration.
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 reliable, key reproductive toxicity study with T008506 is available. Data from the supporting substance DHEA is used to cover this endpoint. Two publications were considered in this assessment of effects on fertility:
Lin et al. 2006 (supporting, K2)
Maternal and fetal toxicity of DHEA is investigated. SD pregnant female rats were divided randomly into 5 groups, 16 rats per group. The rats in the positive control group received aspirin 300 mg/kg and distilled water was given to rats as the negative control group. Three DHEA groups were treated with 10.4, 20.8 and 41.7 mg/kg. The rats were given DHEA from 7d to 16d pregnant continuously for 10 days, and were sacrificed on 20th day of pregnancy. Adverse effects on pregnant rats and fetuses were assessed. DHEA at 10.4 mg/kg caused miscarriages in pregnant rats. 20.8 and 41.8 mg/kg slowed down the weight increase of mother and fetuses, and slowed sternum growth. At 41.7 mg/kg visceral abnormality in fetuses increased. All three concentrations of DHEA decreased the number of living fetuses. In conclusion, DHEA had adverse effects in both pregnant rats and fetuses.
Gotz et al., 1983 (K2, key study)
No reliable, key reproductive toxicity study is available for T008506. Therefore, reliable data from the supporting substance DHEA is used to cover this endpoint. Published data from experimental studies with DHEA are considered. Neonatal treatment of male and female rats with DHEA has adverse effects on the growth and weight of sex organs of both sexes, as well as negatively impacting sexual behaviours. It is assumed that the LOAEL is 1mg/day or 4mg/kg/day in rat after subcutaneous administration.
Effects on developmental toxicity
Description of key information
No reliable developmental toxicity study with T008506 is available. Data from the supporting substance DHEA is used to cover this endpoint.
No effects on embryonic or fetal development were observed in New Zealand White rabbits , dosed orally during GD7-20 with DHEA at dose levels of 0, 20, 50 or 125 mg/kg/day (Kirchner et al., 1998, K2, supporting). In the same study, CD rats were dosed orally with DHEA during GD6-17 at dose levels 0, 5, 15 or 50 mg/kg/day. Embryolethality and increased early resorptions occurred at all dose levels in rats, including complete litter loss. Skeletal malformations were also observed. DHEA may interfere with the energy requirements of the developing embryo or perturb the hormonal balance necessary to maintain implantation. It can be assumed that the LOAEL is 5 mg/kg/day in rats after oral administration.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Justification for the read-across approach is included in section 13
- Reason / purpose for cross-reference:
- read-across source
- Conclusions:
- No relable data with the target substance is available. Data from the supporting substance DHEA is used to cover this endpoint.
No effects on embryonic or fetal development were observed in New Zealand White rabbits , dosed orally during GD7-20 with DHEA at dose levels of 0, 20, 50 or 125 mg/kg/day.
In the same study, CD rats were dosed orally with DHEA during GD6-17 at dose levels 0, 5, 15 or 50 mg/kg/day. Embryolethality and increased early resorptions occurred at all dose levels in rats, including complete litter loss. Skeletal malformations were also observed. DHEA may may interfere with the energy requirements of the developing embryo or perturb to hormonal balance necessary to maintain implantation.
It can be assumed that the LOAEL is 5 mg/kg/day in rats after oral administration.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 5 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No reliable reproductive or developmental toxicity data is available for T008506. Data from the supporting substance DHEA is used to cover this endpoint. The substance T008506 is considered classified as reproductive toxicant category 1B according to CLP regulation.
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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