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EC number: 701-359-2 | 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 and dermal LD50 of the test substance was determined to be > 2,000 mg/kg bw.
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 September 27, 2011 to October 14, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Specific Gravity / Density: 1.14 g/cm3; pH: (1% in water, indicative range) 5.5 – 5.5 (determined at NOTOX); Stability at higher temperatures: yes, maximum temperature 40°C.
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- strain Crl:WI (Han) (outbred, SPF-Quality).
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age and body weight: young adult animals (approx. 9 weeks old) were selected. Body weight: variation did not exceed +/- 20% of the sex mean. Identification: earmark. Health inspection: a health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.
Conditions: animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 19.3 – 21.2ºC), a relative humidity of 40-70% (actual range: 44 - 76%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Accommodation: group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. Diet Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). Water: free access to tap water.
Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of test substance and vehicle. In consultation with the sponsor, in order to obtain homogeneity, the test substance and test substance formulations were heated in a water bath. The test substance was heated at a maximum temperature of 40ºC for a maximum of 1 hour and 55 minutes. The test substance formulations were heated at a maximum temperature of 55.8ºC for a maximum of 18 minutes. The test substance formulations were allowed to cool down to a temperature of maximally 38ºC prior to dosing.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Each dose group consisted of 3 animals.
- Control animals:
- yes
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Hunched posture was noted for all animals on Day 1. In addition, one animal showed piloerection on Day 1.
- Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- -
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the acute oral toxicity of the test substance was > 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100. The substance (dissolved in polyethylene glycol) was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw. Animals were subject to daily observations and weekly determinations of body weight. Microscopic examination was performed at terminal sacrifice (Day 15). No mortality occurred. Hunched posture was noted for all rats on Day 1. In addition, one animal showed piloerection on Day 1. Body weight gain over the study period was similar to that expected of untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute oral toxicity of the test substance to rats was > 2000 mg/kg bw (Stitzinger, 2011).
Reference
The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
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:
- From October 12, 2011 to October 26, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The study also followed this guideline: "Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions".
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Specific Gravity / Density: 1.14 g/cm3; pH: (1% in water, indicative range) 5.5 – 5.5 (determined at NOTOX); Stability at higher temperatures: yes, maximum temperature 40°C.
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- strain, Crl:WI (Han) (outbred, SPF-Quality).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany. Number of animals 5 males and 5 females (females were nulliparous and non-pregnant). Age and body weight: young adult animals (approx. 11 weeks old) were selected. Body weight: variation did not exceed +/- 20% of the sex mean. Identification: earmark. Health inspection: a health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
Conditions: Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 19.3 – 21.2ºC), a relative humidity of 40-70% (actual range: 46 - 73%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Accommodation: individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm). Diet: free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). Water: free access to tap water. Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives. - Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of test substance and vehicle. In consultation with the sponsor, in order to obtain homogeneity, the test substance and test substance formulations were heated in a water bath with a maximum temperature of 55.8ºC for 21 minutes. The test substance formulations were allowed to cool down to a temperature of maximally 25.3ºC prior to dosing.
- Duration of exposure:
- 24h, after which dressings were removed and the skin cleaned of residual test substance using tap water.
- Doses:
- 2000 mg/kg (10 mL/kg) body weight
- No. of animals per sex per dose:
- 5 males and 5 females
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Chromodacryorrhoea was noted in two males and one female on Day 1 only. Yellow discolouration of the back, scabs on the treated skin and/or scales on the back and/or treated skin were observed among the animals. No clinical signs were noted for one male and four females.
- Body weight:
- The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- No toxicologically relevant abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- One male showed diaphragmatic hernia of the median lob of the liver. This is occasionally noted among rats of this age and strain and was considered not toxicologically significant.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the acute dermal toxicity of the test substance was > 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the test substance according to OECD Guideline 402, EU Method B.3 and EPA OPPTS 870.1200. The substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg bw for 24 h. Animals were subject to daily observations and weekly determinations of body weight. Microscopic examination was performed at terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea was noted in two males and one female on Day 1 only. Yellow discolouration of the back, scabs on the treated skin and/or scales on the back and/or treated skin were observed. No clinical signs were noted for one male and four females. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. Finally, no toxicologically relevant abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute dermal toxicity of the test substance was > 2000 mg/kg bw (Stitzinger, 2011).
Reference
A dermal LD50 value was derived. The results were evaluated according to: Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral toxicity
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100.The substance (dissolved in polyethylene glycol) was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw. Animals were subject to daily observations and weekly determinations of body weight. Microscopic examination was performed at terminal sacrifice (Day 15).No mortality occurred. Hunched posture was noted for all rats on Day 1. In addition, one animal showed piloerection on Day 1. Body weight gain over the study period was similar to that expected of untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute oral toxicity of the test substance to rats was > 2000 mg/kg bw (Stitzinger, 2011).
Dermal toxicity
A study was conducted to determine the acute dermal toxicity of the test substance according to OECD Guideline 402, EU Method B.3 and EPA OPPTS 870.1200. The substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg bw for 24 h. Animals were subject to daily observations and weekly determinations of body weight. Microscopic examination was performed at terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea was noted in two males and one female on Day 1 only. Yellow discolouration of the back, scabs on the treated skin and/or scales on the back and/or treated skin were observed. No clinical signs were noted for one male and four females. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. Finally, no toxicologically relevant abnormalities were found at macroscopic post mortem examination. Under the study conditions, the acute dermal toxicity of the test substance was > 2000 mg/kg bw (Stitzinger, 2011).
Justification for classification or non-classification
The acute oral and dermal LD50 values of the substance in rats are both > 2000 mg/kg bw. No classification is therefore required for these endpoints according to CLP (1272/2008) criteria.
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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