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EC number: 473-820-3 | 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
ORAL
LD50 >2500 mg/kg (rat); OECD 423 and EU method B.1 tris
DERMAL
LD50 >2000 mg/kg (rat); OECD 402 and EU method B.3
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:
- 14 March 2001 to 6 April 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: Males: 225 - 238 g; Females: 201 - 205 g
- Fasting period before study: Overnight fast immediately before dosing
- Housing: solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, 12 hours light
IN-LIFE DATES: NDA - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: NDA
- Lot/batch no. (if required): NDA
- Purity: NDA
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual): The test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: NDA - although it is reasonable to assume the testing laboratory had prior information leading to the selection of the inital dose level of 2000 mg/kg. - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 2000 mg/kg: 3 male, 3 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: NDA - Statistics:
- NDA
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: there were no signs of systemic toxicity
- Gross pathology:
- Effects on organs: no abnormalities were noted at necropsy.
- Other findings:
- - Organ weights: NDA
- Histopathology: NDA
- Potential target organs: NDA
- Other observations: NDA - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was estimated from the attached flow chart (Test Procedure with a Starting Dose of 2000 mg per kg bodyweight.pdf) as being greater than 2500 mg/kg bodyweight.
No mortalities were noted in animals treated with 2000 mg/kg bodyweight. - Executive summary:
In an acute oral toxicity study (656/089), a group of 6 fasted eight week old Sprague Dawley strain rats (three male and three female) were given a single oral dose of Experimental 11214-70 in arachis oil at a dose level of 2000 mg/kg bw and observed for 15 days.
Combined Oral LD50(estimated):>2500 mg/kg bw
No mortality occurred. No signs of systemic toxicity were noted during the study, and no abnormalities were noted at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- The study was conducted in accordance with standardised guidelines under GLP conditions and was awarded reliability score of 1. The quality of the database is therefore considered to be high.
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:
- 25 February 2008 to 10 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: at least 200g. The weight variation did not exceed ± 20% of the mean weight for each sex, except for one male animal which was slightly outside this range. This deviation was considered not to affect the purpose or integrity of the study.
- Fasting period before study: None
- Housing:suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 25 February 2008 To: 10 March 2008 - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: NDA
- % coverage: approximately 10 % of total body surface area
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material
- Time after start of exposure: after 24-hour contact
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: NDA
VEHICLE
- Amount(s) applied (volume or weight with unit): the appropriate amount of test material, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin
- Concentration (if solution): N/A
- Lot/batch no. (if required): NDA
- Purity: NDA - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg: 5 male, 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4
Oedema Formation Value
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Any other skin reactions, if present were also recorded.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: None - Statistics:
- No data available.
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Organ weights: NDA
- Histopathology: NDA
- Potential target organs: NDA
- Other observations: there were no signs of dermal irritation - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
In an acute dermal toxicity study (0656/0379), a group of ten 8-12 week old Sprague-Dawley strain rats (five male and five female) were dermally exposed to Experimental 11591-54 in arachis oil for 24 hours to approximately 10 % of total body surface area at a dose level of 2000 mg/kg bw. Animals then were observed for 14 days.
Combined Dermal LD50: >2000 mg/kg bw
No mortality occurred. No signs of systemic toxicity were noted during the study, and no abnormalities were noted at necropsy. No signs of irritation exhibited in any animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted in accordance with standardised guidelines under GLP conditions and was awarded reliability score of 1. The quality of the database is therefore considered to be high.
Additional information
Oral
The acute oral toxicity of the test material to the rat was investigated using the acute toxic class method in accordance with the standardised guidelines OECD 423 and EU Method B.1 tris under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
Three male and three female fasted Sprague-Dawley rats were exposed to a 2000 mg/kg limit dose of the test material in arachis oil via gavage. The rats were observed for 14 days.
No mortality occurred. No signs of systemic toxicity were noted during the study, and no abnormalities were noted at necropsy.
Under the conditions of this study the Combined Oral LD50(estimated) was >2500 mg/kg bw.
Inhalation
In accordance with section 8.5.2 of Column 2 of REACH Annex VIII, the acute toxicity by inhalation study does not need to be conducted as exposure of humans via inhalation is unlikely given the low vapour pressure and low proportion of particles of an inhalable size.
Dermal
The acute dermal toxicity of the test material to the rat was investigated using the standard acute method in accordance with the standardised guidelines OECD 402 and EU Method B.3 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
Five male and five female Sprague-Dawley rats were exposed to a 2000 mg/kg limit dose of the test material in arachis oil in a semi-occlusive fashion for 24 hours. The rats were observed for 14 days.
No mortality occurred. No signs of systemic toxicity were noted during the study, and no abnormalities were noted at necropsy. No signs of irritation were exhibited in any animals.
Under the conditions of this study the Combined Dermal LD50 was >2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral or dermal route.
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