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EC number: 700-627-6 | CAS number: 17270-01-8
- 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 rat (standard acute method): LD50 > 2000 mg/kg bw (no mortality at up to and including this dose)
Acute dermal rat: LD50 > 2000 mg/kg bw (no mortality at this dose)
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: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- of 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- of 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sprague Dawley rats, strain: Crl:CD (SD) IGS BR with appropriate range of bodyweight at study start.
- Source: Charles River UK Ltd., Margate, Kent, UK.
- Age at study start (day of dosing): 8 to 12 weeks.
- Weight at start (day of dosing): Females: minimum 205 g, maximum 243 g.
- Housing: Group housing with up to 4 animals in suspended solid-floor propylene cages.
- Bedding material: Woodflakes.
- Fasting period: Overnight immediately prior to dosing until 3-4 hours post administration.
- Diet (ad libitum, except for fasting period): Commercially available standard laboratory animal diet:
Certified Rat and Mouse Diet
- Water (ad libitum*): Mains drinking water
- Acclimation period: At least 5 days before start of dosing.
* Remark: The study report does not clearly state whether or not water was supplied during the fasting period.
ENVIRONMENTAL CONDITIONS
The animal room was maintained at target ranges of:
- Temperature (°C): 22 ± 3°C
- Relative Humidity (%): 30 to 70%
- Photoperiod: 12 h day / 12 h night
- Rate of air exchange: At least 15 changes/h
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Target dose of test material --- Concentration of test material in vehicle: 300 mg/kg bw --- 30 mg/mL
2000 mg/kg bw --- 200 mg/mL
- Amount (dose volume by gavage): 10 mL/kg bw
(individual dose volume was calculated based on individual fasted bodyweight at the time of dosing).
DOSAGE PREPARATION:
The test material, was freshly prepared as a solution in dimethyl sulphoxide (DMSO). DMSO was used as a vehicle, because the test material did not dissolve in distilled water or arachis oil BP.
RATIONALE FOR DOSE SELECTED:
The choice of the limit dose of 2000 mg/kg bw was appropriate in the main test, because doses of 300 mg/kg and 2000 mg/kg did not induce any deaths, clinical signs of toxicity, adverse effects on bodyweight or necropsy findings in sequential preliminary sighting studies with 1 female rat/dose. - Doses:
- 300 mg/kg bw (1 female)
2000 mg/kg bw (5 females) - No. of animals per sex per dose:
- 5 (females only)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observation of clinical signs: 0.5, 1, 2 and 4 h post dosing on the day of administration (Day 0) and subsequently once daily for 14 days.
Weighing of each animal: Day 0 for dose calculation and on Days 7 and 14.
- Necropsy performed: yes, of all sighting and main study animals. - Statistics:
- Not applicable, as there were no deaths
- Preliminary study:
- There were no deaths, clinical signs of toxicity, adverse effects on bodyweight or necropsy findings in a preliminary sighting study at a dose of 300 mg/kg bw administered to 1 female rat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at 300 mg/kg (sighting) and at the limit dose of 2000 mg/kg
- Mortality:
- Single Dose at Mortality
300 mg/kg 0/1 (f)
2000 mg/kg 0/5 (f) - Clinical signs:
- other: Clinical signs of systemic toxicity were not evident.
- Gross pathology:
- Necropsy of each animal at the end of the 14-day post treatment observation period did not reveal any macroscopic pathology findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information No deaths at 300 mg/kg (sighting) and at the limit dose of 2000 mg/kg Criteria used for interpretation of results: EU
- Conclusions:
- In view of the oral LD50 > 2000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any classification or labelling regarding acute oral toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- January 28 - February 11, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- of 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Wistar rats, strain: Crl:WI (Han) (outbred, SPF-Quality), with appropriate range of bodyweight at study start.
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation (day of dosing): Approx. 12 weeks.
- Weight at study initiation( day of dosing): Mean (males): 337 g, minimum 324 g, maximum 349 g.
Mean (females): 211 g, minimum 207 g, maximum 217 g.
- Housing: Individual housing in M III type cages. (During acclimatization group housing in M IV type cages).
- Bedding material: Sterilized sawdust (Litalabo, S.P.P.S., Argenteuil, France).
- Cage enrichment: Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, UK).
- Diet (ad libitum): Commercially available rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before treatment start under laboratory conditions.
Routine analysis of the sawdust, paper, diet and water, did not provide evidence of contamination that might have affected the study integrity.
ENVIRONMENTAL CONDITIONS
Animal housing and environmental conditions were appropriate for acute toxicity testing in the rat: Controlled environment with approximately 15 airchanges per hour, 12 hours artificial fluorescent light and 12 hours darkness per day, 19.0 - 20.5°C and 48 – 78% relative humidity. Due to a technical failure of the temperature and relative humidity sensors in the animal room in which in which the animals were housed, the temperature and relative humidity records were taken from another animal room connected to the same temperature and relative humidity regulation system and therefore considered to be representative for the present study. - Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 400 (Merck, Darmstadt, Germany)
- Details on dermal exposure:
- TEST SITE
- Preparation: One day before exposure an area of approximately 5x7 cm on the back of the animal was clipped. During health inspection of the animals prior to commencement of treatment, special attention was paid to the skin to be treated, which was intact and fre e from any abnormality.
- Area of treated skin: Ca. 25 cm2 in males, ca.. 18 cm2 in females corresponding to ca. 10% of total body surface.
- Type of wrap used: Surgical gauze patch (Surgy 1 D), successively covered with aluminium foil and Coban elastic bandage. For females additional
fixation of the bandage with Micropore tape.
REMOVAL OF TEST SUBSTANCE
Occlusive treatment of the clipped, intact skin lasted 24 hours. Then the dressings (gauze, foil, bandages, tape) were removed and residual test substance washed off the skin with tap-water.
TEST MATERIAL AND DOSE PREPARATION
- Administered Dose of test substance: 2000 mg/kg bw
- Administration Volume: 10 mL per kg body weight (specific gravity of the vehicle of 1.125 was accounted for)
The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
- Justification for choice of vehicle:
Trial formulations at the testing laboratory and test substance data supplied by the sponsor led to the choice of this vehicle. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of the observation period following administration start (day 1) was 14 days during which mortality/survival and clinical signs were recorded at: 0, 2 and 4 hours after administration start on day 1 and twice daily (mortality/survival) or once daily (clinical signs) thereafter until day 15. Body weight was recorded on days 1 (prior to administration), 8 and 15 for each animal. On day 15, all animals were necropsied and macroscopic pathology findings recorded.
- Statistics:
- Statistical analysis is inappropriate for this study, as there was only one dose group.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at the limit dose of 2000 mg/kg.
- Mortality:
- There were no premature deaths.
- Clinical signs:
- other: Clinical signs were confined to Day 2, comprising of: - hunched posture in all animals (Nos. 1 to 10) - piloerection in two male animals (Nos. 1 and 4) and - chromodacryorrhoea (snout), slight in degree, in one male animal (No. 1).
- Gross pathology:
- Necropsy of each animal did not reveal any macroscopic pathology findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In view of the dermal LD50 > 2000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any classification or labelling regarding acute dermal toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Both, the acute oral and the acute dermal toxicity studies demonstrated that the LD50 of ADK STAB FP-800 for the respective exposure route is considerably higher than the limit dose of 2000 mg/kg b.w.
Justification for classification or non-classification
In both, the acute oral and the acute dermal toxicity studies with ADK STAB FP-800, all animals survived the limit dose of 2000 mg/kg b.w.. Therefore, classification of ADK STAB FP-800 for acute oral or dermal toxicity is not required [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008].
Non-classification of ADK STAB FP-800 by the inhalation route was justified by its low vapour pressure making the inhalation exposure of humans to any vapour phase of it unlikely. Further, the vast majority of the solid form comprises flakes and particulate material > 100 µm generally regarded as not inhalable by humans. The liquid form is very viscous limiting its availability as inhalable aerosol.
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