Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 403-360-0 | CAS number: 42405-40-3 BONTRON E-84; E-84
- 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
Subacute NOAEL (rat): 80mg/kg bw (Method B7 of directive 84/449/EEC, OECD 407; GLP)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline and GLP compliant study
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 84/449/EEC, Method B7
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- other: rat, Wistar albino
- Route of administration:
- oral: unspecified
- Vehicle:
- other: no vehicle used
- Details on oral exposure:
- Method of administration:
Diet administration - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 16.1 mg/kg bw/day
Male: 5 animals at 80.4 mg/kg bw/day
Male: 5 animals at 433 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 16.9 mg/kg bw/day
Female: 5 animals at 81.7 mg/kg bw/day
Female: 5 animals at 375 mg/kg bw/day - Details on results:
- Clinical observations:
Emaciation and rough, dirty coats were observed in group 4: growth , food intake and food efficiency decreased. No other findings.
Laboratory findings:
Haematology:
Group 4: slight increase in red blood cells, haemoglobulin concentration and packed cell volume. Slightly lower total thrombocyte counts.
Clinical biochemistry:
Group 4: Increase in alkaline phosphatase, GOT and GPY activities and in total bilirubin, urea and chloride levels.
Also a decrease in fasting blood glucose level was noted.
Urinalysis:
Group 4 females: a slight dose-related increase in urine production, related to a decrease in urine density.
Effects in organs:
Group 4: decrease in absolute liver weights (male and female) and in several other organs (females only). Relative weights of testes and adrenals were increased (males only)
The relative weight of the liver was slightly increased in males of Group 3 and decreased in females in Group 4.
Pathology:
Group 4: 9/10 animals showed less pronounced lobular pattern compared to the control animals, due to hypertrophy of the centrilobular hepatocytes.
All other findings were commonly seen in the strain of rats used. - Dose descriptor:
- NOAEL
- Effect level:
- ca. 80 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- ca. 80 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 80 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Information from migrated NONS file, as per inquiry number 06-0000021669-59-0000.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral Route:
The repeated oral dose toxicity of bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) has been evaluated in 4 studies.
One study was disregarded as it was indicated as following OECD 410/GLP, even though data was presented from an oral acute study.
A supporting study with the lowest NOAEL value (60mg/kg bw/day) did not follow any guideline or GLP compliance and was so it was not possible to assess reliability.
Another supporting oral gavage study (OECD 407/GLP) indicated a NOAEL of 240 mg/kg day and NOEL of 15 mg/kg/day with clinical biochemistry (males and females) and haematological (females) changes. Increases in relative liver weights in high dose females were noted but microscopically, there were no treatment-related findings.
The study chosen as the key study was conducted in accordance with Method B7 of directive 84/449/EEC (supporting text indicated OECD 407) and GLP. The substance was administered in the diet at 0, 200 ppm, 1000 ppm up to a maximum dose of 5000 ppm (males: 433 mg/kg bw and females: 375 mg/kg bw) in 5 male and 5 female rats for 28 days. Clinical observations at the highest dose group included decreased food intake and growth. Although clinical biochemistry alterations in the high dose group included hepatic and hepatobiliary enzyme level changes (GOT/AST, GPT/ALT, AP) and pathological investigations of the liver post-mortem revealed hypertrophy of hepatocytes, there was no additional histopathological analysis to confirm any toxicologically significant changes due to treatment. NOEL and NOAEL values of 80mg/kg bw were assigned and a NOAEL of 80mg/kg bw will be used as the key value for repeated dose oral toxicity.
[U1]This need to be revised.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
OECD Guideline and GLP compliant study
Justification for classification or non-classification
According to the Directive 67/548/EEC, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) is not classified for repeated dose toxicity.
According to the CLP Regulation, the substance bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc (CAS No. 42405-40-3) does not need to be classified for specific target organ toxicity (repeated).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.