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EC number: 400-830-7 | CAS number: 104810-48-2 EVERSORB 80; TINUVIN 1130; TINUVIN 213
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: Anex V (with gross necropsy of pubs at day 21 post partum, and histopathological examination of all test and control parental animals including examination of liver and kdneys).
- GLP compliance:
- yes
- Species:
- other: Rat (Tif: RAlf)
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- other: PEG 300
- Details on exposure:
- Method of administration or exposure: Gavage
Mass median aerodynamic diameter:
EXPOSURE FREQUENCY/DURATION:
Males: daily, for 70 days prior to mating and through the mating period to parturition (ie daily for 96 days, 5 days without treatment, then daily for 19 days).
Femles: Daily for 14 days prior to mating and through mating, pregnancy and lactation. - Analytical verification of doses or concentrations:
- not specified
- No. of animals per sex per dose:
- Male: 25 animals at 0 mg/kg or mg/l
Male: 25 animals at 2 mg/kg or mg/l
Male: 25 animals at 50 mg/kg or mg/l
Male: 25 animals at 100 mg/kg or mg/l
Female: 25 animals at 0 mg/kg or mg/l
Female: 25 animals at 2 mg/kg or mg/l
Female: 25 animals at 50 mg/kg or mg/l
Female: 25 animals at 100 mg/kg or mg/l - Reproductive effects observed:
- not specified
Reference
Minimal-moderate hepatocyte hypertrophy at 50 nd 100 mg/kg and minimal-moderate hepatocyte nerosis in the liver at 100 mg/kg, particularly in males (see comments). Minimal-slight accumulation of iron positive pigment in the liver and kidneys of males at 50 and 100 mg/kg.
There was no evidence of an adverse effect of treatment on reproductive performance of the males or females. No treatment-related pathological effects on the male or female reproductive system were seen.
b) Special investigations of the male liver: Eletron microscopy revealed a striking proliferation of peroxisomes at 50 and 100 mg/kg. Some change in the appearance of peroxisomes was noted at 2 mg/kg. Minor treatment-related effects of smooth endoplasmic reticulum (proliferation) and mitochondria (dilated cristae) were noted at all dose levels. treatment-related changes in enzyme activity, indicative of peroxisome proliferation, were noted at all dose levels.
Clear increase in perinatal mortality at 100 and 50 mg/kg, with slight increase at 2 mg/kg (number of females with stillborn pups: 9,5,2;0 in control group).
At 100 mg/kg there was also: increased prenatal loss, decreased pup survival to day 4 post partum (p.p.) reduced birth weight, slightly reduced mean pup weight (11%) during lactation and slight delay in physical development (eye opening, tooth eruption).
At birth, dark skin (occasionally described as necrotic) was noted on the body, limbs and/or tail of one pup at 50 mg/kg and 25 pups at 100 mg/kg.
Of the pubs surviving to day 21 p.p., a necrotic tip to tail was noted in one at 50 mg/kg and 4 at 100 mg/kg.
Comments:
Mating schedule: 1 male with 1 female
NO OBSERVED EFFECT LEVELS: Parental animals: < 2 mg/kg/day
F1 generation: < 2 mg/kg/day
No apparent treatment-related adverse effect was observed on the reproductive performance of the P generation, but no information is available on any long-term effect on reproductive performance in the F1 generation.
The substance is clearly fetotoxic, but only minor effects were apparent at weaning. Fetotoxicity appeared to be due primarily to prenatal exposure and not to exposure via the milk. Similar fetotoxic effects were seen in the sighting study.
The description of the parental liver effects detected by light microscopy and reported above is based on a peer review commissioned by the notifier. organising necrosis (nerotic tissue in which granulation tissue is forming) was also noted in the liver, paticularly in males at 50 mg/kg, but the review conluded it to be of doubtful significance (possibly due to infection). The slight increase in single cell hepatocyte necrosis in high dose males was considered to be seondary to accelerated hepatocyte turnover in the enlarged liver. There were no clear treatment-related necrotic liver effects in females.
The special liver studies show that the substance is a potent peroxisome proliferator in the male rat liver.
See also coment of the UK c.a.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 mg/kg bw/day
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- other: Rat (Tif: RAlf (SPF))
- Route of administration:
- oral: unspecified
- Vehicle:
- other: PEG 300
- Details on exposure:
- Method of administration or exposure: Gavage
- No. of animals per sex per dose:
- Number of dams and doses
24 at 0 mg/kg or mg/l
24 at 1 mg/kg or mg/l
24 at 30 mg/kg or mg/l
24 at 150 mg/kg or mg/l - Details on maternal toxic effects:
- Details on maternal toxic effects:
No deaths treatment-related occured. Maternal bodyweight gain was reduced at 150 mg/kg. - Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: other:
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross:
There were no dead or absorbed foetuses. Numbers of live foetuses/litter and foetal weights were comparable between the groups.
Effects on fetus - Soft tissue:
Enlarged thymus was observed in a small group of foetuses from all groups. Accessory lobulets on the liver were observed in 2, 2 and 1 foetuses of groups 2, 3 and 4 respectively.
Efects on fetus - Skeletal:
No skeletal malformations werde observed. A significant increase in the incdence of litters affected with asymmetrically shaped sternebra-5 in group 4. This was attibuted to delayed ossification, related to maternal toxicity. - Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
Justification for classification or non-classification
Based on the available information in the dossier, the substance 400-830-7 need not to be classified as reproductive toxicity when considering the criteria outlined in Annex VI of 67/548/EEC and in Annex I of 1272/2008/EC.
Additional information
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