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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 433-470-4 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Using OECD and EC Commission guideline methods and conducted to GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- Used a single dose level instead of multiple levels
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- SETAFIX X 11342
- IUPAC Name:
- SETAFIX X 11342
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): SETAFIX X 11342
- Molecular formula (if other than submission substance): C22H26O6
- Molecular weight (if other than submission substance): 386g/mol
- Substance type: Light Yellowish Solid
- Physical state: Solid
- Analytical purity: >95% resin
- Lot/batch No.: PP03
- Expiration date of the lot/batch: 31st December 2004
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 females and 5 males (females were nulliparous and non-pregnant).
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx 8 weeks
- Weight at study initiation: Body weight variations did not exceed +/-20% of the sex mean (Mean on day 1 274g for males, 195g for females)
- Housing: Individually housed in labelled Macrolon cages (type III, height 15cm) containing purified sawdust as bedding material (woody clean type 3/4; Tecnilab_BMI BV, Someren, the Netherlands)
- Diet (e.g. ad libitum):Free acccess to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0+/-3.0C
- Humidity (%): 30-70% relative
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx 25cm2 for males and 18cm2 for females.
- % coverage: approx 10% of total body surface area
- Type of wrap if used: Formulation was held in contact with skin with a dressing consisting of a surgical gauze patch (Surgy 1D) usccesively covered with aluminium foil and Coban elastic bandage. A piece of micropore tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleansed of residual test substance using water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/L in Propylene glycol
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- single dosage on Day 1
- No. of animals per sex per dose:
- 5 females and 5 males (females were nulliparous and non-pregnant).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily observations
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical Signs, Body Weight, Macroscopic Findings
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 95
- Mortality:
- No mortality occured
- Clinical signs:
- other: Clinical Signs Lethargy, hunchedlflat posture andlor chromodacryorrhoea, were noted in the majority of animals between days 1 and 6. In addition, diarrhoea and ptosis were seen in some males on days 1 or 2. Also, erythema (focal, maculate or general), sca
- Other findings:
- Macroscopic Findings
Enlargement of the mandibular lymph nodes (uni- or bilateral) was noted in two males and two females.
No further abnormalities were found at macroscopic post mortem examination of the animals
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information: Dermal LD50 value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mglkg body weight.
- Conclusions:
- The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity. - Executive summary:
The dermal value of Setafix X 11 342 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the: - OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), Setafix X 1 1342 does not have to be classified for acute toxicity by the dermal route. - EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 671548lEEC), Setafix X 11 342 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.
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.