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EC number: 926-195-0 | CAS number: 1176284-65-3
- 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
The oral LD50 is > 2000 mg/kg bw in rats.
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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- minor, not affecting the outcome. Clinical observations made at 4 hours 30 minutes rather than 4 hours after dosing in Step 2. Food replaced in cages at 4 hours 30 minutes rather than at 4 hours, in Step 2.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- minor, not affecting the outcome. Clinical observations made at 4 hours 30 minutes rather than 4 hours after dosing in Step 2. Food replaced in cages at 4 hours 30 minutes rather than at 4 hours, in Step 2.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories S.r.l.
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 6-7 weeks
- Weight at study initiation:157-165g
- Housing:
- Diet (e.g. ad libitum): ad libitum, ssniff SM
- Water (e.g. ad libitum): ad libitum, municipal water supply
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-57
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:TEST ANIMALS - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Doses:
- One dose of 2000 mg/kg body weight was given only once on day 1.
- No. of animals per sex per dose:
- 6 individual female rats were all given the same dose of 2000 mg/kg of body weight.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations made twice daily. Weights measured at allocation, on the day of dosing and on days 2, 8 and 15.
- Necropsy of survivors performed: yes, on all animals.
- Other examinations performed: no histopathology - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality at the limit dose of 2000 mg/kg bw
- Clinical signs:
- other: No clinical signs noted
- Gross pathology:
- No pathology noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the test material is low, with a LD50 greater than 2000 mg/kg body weight. The substance is not classified according to Regulation EC No. 1272/2008.
Reference
No mortality occurred and no clinical signs were observed in the first group of animals initially dosed at 2000 mg/kg (Group 2, Step 1) and in the further group of 3 females dosed at the same dose level (Group 4, Step 2).
The results indicate that ZWA 5496/100 did not induce toxic effects in any of the rats following oral administration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- adequate
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- 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 [exposure considerations]. Furthermore, according to Annex VIII, Section 8.5, Column 2, of Regulation EC No. 1907/2006, a toxicity study, in addition to the acute oral toxicity study, under 8.5.2 to 8.5.3 shall be provided for at least one other route. Regulation EC No. 863/2016 amends this data requirement, stating that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. The risk of acute toxicity by the dermal route has been addressed in light of an acute oral toxicity study with a LD50 > 2000 and no systemic toxicity observed in other in vivo studies. It is determined that testing for acute dermal toxicity is not scientifically indicated. The criteria for satisfaction of Sections 8.5.2 and 8.5.3 are met and the data requirement for an acute toxicity study by a third route, inhalation, is waived.
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:
- Justification for type of information:
- According to Regulation EC No. 863/2016 amending Regulation EC No. 1907/2006, acute testing by the dermal route does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route, and no systemic effects have been observed in in vivo studies with dermal exposure. The test material displayed an acute oral LD50 > 2000 mg/kg bw in rats, is not classified as STOT SE, and no systemic toxicity or local irritation was observed in a LLNA study in mice. Therefore the substance meets the criteria for waiving the testing requirements for acute dermal toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute inhalation toxicity 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. Furthermore, according to Commission Regulation (EU) 2016/863 amending Regulation EC No. 1907/2006, acute dermal toxicity testing does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route, and no systemic effects have been observed in in vivo studies with dermal exposure. The test material displayed an acute oral LD50 > 2000 mg/kg bw in rats, no evidence of systemic toxicity in a repeated dose toxicity study, and is not classified as STOT SE. The study for acute inhalation toxicity is not required, as the acute toxicity of two routes of administration have been addressed, as required by Regulation EC No. 1907/2006, Annex VIII.
Justification for classification or non-classification
The oral LD50 of the substance is > 2000 mg/kg bw in female Wistar rats, and hence is not classified. No study for dermal toxicity was undertaken based on Commission Regulation (EU) 2016/863. No systemic toxicity was observed in a dermal LLNA study of the substance, nor was there systemic toxicity observed in a 28-day repeated dose and reproductive toxicity screening test. The criteria for classification for acute toxicity in Regulation EC No. 1272/2008 is not met and the substance is not classified.
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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