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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
Endpoint summary
Administrative data
Description of key information
The oral LD50 value of 1070 GA 051 in Wistar rats was established to
exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification
and labelling requirements for dangerous substances and preparations
(Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not
have to be classified and has no obligatory labelling requirement for
oral toxicity.
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.
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:
- key study
- Study period:
- 06/07/2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD test method and to GLP standards
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx 8 weeks old
- Weight at study initiation: +/- 20% of the sex mean (Mean of 190g for females, 303g for males on Day 1)
- Fasting period before study: Overnight, maximum of 20 hours prior to dosing until approx 3-4 hours after administration of the test substance.
- Housing: 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelletd laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21Centigarde
- Humidity (%): 50% relative
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day. - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- SG 1.036
- Details on oral exposure:
- Maximum dose volume applied: 2000mg/kg
- Doses:
- Single dose on day one. 2000mg/kg (10ml/kg) body weight
- No. of animals per sex per dose:
- 1 group of 3 males and 1 group of 3 females, all with the same 2000mg/kg dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily for mortaility/viability and Body weights on days 1, 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight and macroscopic findings - Statistics:
- No statistical analysis was performed.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality occured
- Clinical signs:
- other: No clinical signs were noted
- Other findings:
- Macroscopic findings: No abnormalities were found at macroscopic post mortem examination of the animals
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity. - Executive summary:
The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commision Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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.
- 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
- 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 - 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 - 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 - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for selection of acute toxicity – oral endpoint
The oral LD50 value of 1070 GA 051 in Wistar rats was established to
exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification
and labelling requirements for dangerous substances and preparations
(Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not
have to be classified and has no obligatory labelling requirement for
oral toxicity.
Justification for selection of acute toxicity – inhalation endpoint
Inhalation study is only required if exposure is likely to occur or
if a dermal tox study is NOT available.
Exposure is not expected to occur during normal intended use and robust
study summaries with a Klimisch 1 rating for both Dermal and Oral
toxicity are available for this substance. Therefore there is no need to
run this study.
Justification for selection of acute toxicity – dermal endpoint
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.
Justification for classification or non-classification
The oral LD50 value of 1070 GA 051 in Wistar rats was established to exceed 2000mg/kg body weight.
Based on these results and according to EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in commission Directive 93/21/EEC), 1070 GA 051 does not have to be classified and has no obligatory labelling requirement for oral toxicity.
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.
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