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Diss Factsheets
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EC number: 942-732-1 | 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 acute toxicity study by oral route was conducted on the registered substance according to OECD Testing Guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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:
- From 29 January 2016 to 29 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 420. The study was conducted on the registered substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Envigo RMS (UK) Limited- Age at study initiation: 8-12 weeks- Weight at study initiation: 155-174g- Fasting period before study: overnight prior to dosing and 3 to 4 hours after- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes- Diet: ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25- Humidity (%): 30-70- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light cycle
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- For the purpose of the study the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical observations at 30 minutes, 1, 2 and 4 hours after dosing then daily. Body weights recorded on days 0, 7 and 14- Necropsy of survivors performed: yes
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- Noisy respiration noted in one animal 9-11 days after dosing
- Body weight:
- All animals showed expected body weight gains
- Gross pathology:
- No abnormalities noted
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute toxicity study by oral route was conducted on the registered substance according to OECD Testing Guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
The acute toxicity: oral of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 420.
Following a sighting test at dose level 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There was no mortality, all animals showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy. The only clinical observations observed was one animal showed noisy respiration between days 9 and 12. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Individual Clinical Observations and Mortality Data
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing | Effects Noted During Period After Dosing (Days) | ||||||||||||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
2000 | 1 -0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 -0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 -1 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | Rn | Rn | Rn | 0 | 0 | 0 | |
2 -2 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 -3 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0= No signs of systemic toxicity
Rn= Noisy respiration
Individual Body Weights and Body Weight Changes
Dose Level mg/Kg | Animal Number and Sex | Body Weight (g) at Day | Body Weight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 1 -0 Female | 155 | 181 | 195 | 26 | 14 |
2 -0 Female | 174 | 186 | 199 | 12 | 13 | |
2 -1 Female | 172 | 181 | 194 | 9 | 13 | |
2 -2 Female | 167 | 180 | 190 | 13 | 10 | |
2 -3 Female | 174 | 189 | 197 | 15 | 8 |
Individual Necropsy Findings
Dose Level mg/kg | Animal Number and Sex | Time of Death | Macroscopic Observations |
2000 | 1 -0 Female | Killed Day 14 | No Abnormalities Detected |
2 -0 Female | Killed Day 14 | No Abnormalities Detected | |
2 -1 Female | Killed Day 14 | No Abnormalities Detected | |
2 -2 Female | Killed Day 14 | No Abnormalities Detected | |
2 -3 Female | Killed Day 14 | No Abnormalities Detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was considered as fully reliable as it was conducted on the registered substance, as defined in section 1.1.
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
The acute toxicity: oral of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 420. Following a sighting test at dose levels of 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. At dose 2000 mg/kg there was no mortality, all animals showed expected gains in body weight and no abnormalities were noted at necropsy. One animal showed noisy respiration 9-11 days after dosing. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Justification for selection of acute toxicity – oral endpoint
This study was selected as the key study as it was a GLP study conducted on the registered substance according to OECD Testing Guideline 420. The LD50 was >2000mg/kg bw.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for selection of acute toxicity – dermal endpoint
In accordance with REACH, Annex XI, no testing is required as no significant dermal exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for classification or non-classification
The acute toxicity study by oral route was conducted on the registered substance according to OECD Testing Guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
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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