Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 917-473-2 | CAS number: 188416-34-4
- 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
Acute oral toxicity:
An acute oral toxicity study (HLS, 1994) was available which is key study. This study showed that the oral LD50 value of test substance is between 50 to 500 mg/kg body weight.
Acute dermal toxicity:
An acute dermal toxicity study (McRae, 1998) was available which is key study. This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Doses:
- A group of ten fasted rats(five males and five femals) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose and administered at an initial dose level of 500 mg/kg bodyweight. A further group of five males and five females rats was dosed at 50 mg/kg bodyweight to determine the discriminating dosage of the test material.
- No. of animals per sex per dose:
- Preliminary sighting study: 2 (female)
Main study: 5 (male)
Main study: 5 (female) - Control animals:
- no
- Details on study design:
- A group of ten fasted rats(five males and five femals) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose and administered at an initial dose level of 500 mg/kg bodyweight. This dose level was chosen on the basis of preliminary study results and in compliance with the study guideling. A further group of five males and five females rats was dosed at 50 mg/kg bodyweight to determine the discriminating dosage of the test material.
- Preliminary study:
- Species/strain: Rat (Sprague-Dawley)
2000 mg/kg bw: Evident toxicity: Y; Mortality: Y
500 mg/kg bw: Evident toxicity: Y; Mortality: N
Observations:
These results were used to set the starting dose for the main study. - Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 50 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 500 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Three males and all females at 500 mg/kg died during the study. All deaths occurred within 4 days of dosing.
Female 500 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 5; No. of animals used: 5
Male 500 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 3; No. of animals used: 5
Female 50 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
Male 50 mg/kg bw (fixed dose further) No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5 - Clinical signs:
- other: Signs of toxicity: Clinical signs of reaction to treatment included piloerection and hunched posture, seen in all rats at both dosages. In addition, waddling gait, lethargy, decreased respiration, partially closed eyelids, pallor of the extremities, calo
- Gross pathology:
- Effects on organs:
Macroscopic examination of surviving rats killed on Day 15 revealed no abnormalities. - Other findings:
- Three males and all females at 500 mg/kg died during the study. All deaths occurred within four days of dosing.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 is between 50 and 500 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 50 mg/kg bw
- Quality of whole database:
- 1 (reliable without restriction)
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 28 January to 11 February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- 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: Harlan U.K.Ltd., Bicester, Oxon, England
- Age at study initiation: Eight to ten weeks of age
- Weight at study initiation: 220 to 250 g
- Fasting period before study:
- Housing: They were housed individually in metal cages with wire mesh floors
- Diet: A standard laboratory rodent diet
- Water: ad libitum
- Acclimation period: A minimum period of five days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 32-52% RH
- Air changes (per hr): Maintained at 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700-1900 hours) in 24-hour period
IN-LIFE DATES: From 28 January To 11 February 1997 - Type of coverage:
- occlusive
- Vehicle:
- other: aqueous methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 50 mm * 50 mm
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: Covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water (30 to 40ºC )
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Concentration (if solution): A maximum practical concentration of 66.67% w/v in 1% w/v aqueous methylcellulose
- Constant volume or concentration used: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 3 ml/kg bodyweight
- Concentration (if solution): 1% w/v aqueous methylcellulose
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- a group of ten rats (five males and five females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Once in the morning and again at the end of the experimental day (with the exception of Day 15-morning only)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, mortality - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: There were no signs of systemic reaction to treatment.
- Gross pathology:
- No macroscopic abnormalities were observed for the animals killed on Day 15.
- Other findings:
- Dermal reactions:
Transient slight to well defined dermal irritation (Grade 1 or 2 erythema and oedema) was evident in two males and two females on removal of the dressings, resolving completely by Day 5. In addition, desquamation (characterised by dryness/sloughing/scaling and/or spot/scab formation) was noted in two females during the first week of the study only. No dermal response to treatment was observed in the remaining six animals throughout the study. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of this substance was demonstrated to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1 (reliable without restriction)
Additional information
Acute oral toxicity:
An acute oral toxicity study (HLS, 1994) was conducted according to EU Method B1 which is key study. This study showed that the oral LD50 value of test substance is between 50 to 500 mg/kg body weight.
Acute dermal toxicity:
An acute dermal toxicity study (McRae, 1998) was conducted according to EU Method B3 which is key study. This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
Study run to a method comparable with current guidelines and to GLP.
Justification for selection of acute toxicity – dermal endpoint
Study run to a method comparable with current guidelines and to GLP.
Justification for classification or non-classification
Oral LD50 = 50-500 mg/kg bw, Dermal LD50 >2000 mg/kg bw.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is classified as "Category 4" for acute oral toxicity and not classified for the acute dermal toxicity endpoint.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.