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Diss Factsheets
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EC number: 251-073-2 | CAS number: 32509-66-3
- 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
Description of key information
Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute orally toxic.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Dec 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study design equivalent to OECD Guideline 401 with minor deviation and sufficient reporting.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only females tested
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst bred
- Weight at study initiation: 90 - 104 g
- Fasting period before study: 16 h before administration
- Housing: in plastic cages on a bedding of wood shavings
- Diet (e.g. ad libitum): Altromin 1324 (Atlrogge, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- - concentration in vehicle: 25 % (w/v)
- Doses:
- 15000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
No food was given to he rats for 16 h before administration. Food was given to the animals again 2 h after administration of the product. The period of observation after administration amounted to 14 days. During this period the animals were weighed weekly.
At the end of the subsequent observation period the animals were sacrificed and subjected to macroscopic evaluation. - Statistics:
- None
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Remarks on result:
- other: no effects
- Mortality:
- no mortality observed
- Clinical signs:
- other: The behavior of the animals was normal both after administration and during the subsequent follow-up period.
- Gross pathology:
- Dissection of the sacrificed animals yielded no significant macroscopic findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of Hostanox O 3 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study Hostanox O 3 is not subject for labelling and classification requirements according to regulatory requirements.
- Executive summary:
Hostanox O 3 was tested for its acute oral toxicity potential. 10 female rats were treated with 15000 mg/kg bw and observed for 14 days. No deaths or clinical signs were recorded.
The median lethal dose of Hostanox O 3 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study Hostanox O 3 is not subject for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results of two oral toxicity studies the LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw.
In accordance with
REACH “Column 2” in Annex VIII there is sufficient weight of evidence
from several independent sources of information leading to the
conclusion that
Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not
exert systemic toxic effects after acute inhalation exposure and thus
does not have to be classified, because
- the LD50value for acute oral toxicity of
Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] is greater
15,000 mg/kg bw,
- Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] does not
have to be classified as skin irritating,
- inhalation to consumer is very unlikely to occur, since the substance
is embedded in polymeric matrices for consumer applications and
- occupational health surveillance did not report any reverse effect.
Therefore, it is concluded that testing of acute inhalation toxicity of
Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] is not
scientifically necessary.
It can reasonably be deduced that Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of up to 15,000 mg/kg bw in female rats. Furthermore the substance does not have to be classified as skin irritating. Due to the combination of its molecular weight (795 g/mol) and the extent of the molecular structure it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 15,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.
Justification for selection of acute toxicity – oral endpoint
Study design equivalent to OECD Guideline 401 with minor deviation and sufficient reporting.
Justification for selection of acute toxicity – inhalation endpoint
n.a.
Justification for selection of acute toxicity – dermal endpoint
n.a.
Justification for classification or non-classification
Due to the findings described in the acute oral toxicity study (LD50 oral in rats greater than 15,000 mg/kg bw) Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute orally toxic. Based on the substance's physico-chemical and non-irritant properties, as well as the unlikeliness of exposure no higher systemic exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the two oral toxicity studies. Therefore,Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute toxic.
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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