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EC number: 201-550-6 | CAS number: 84-66-2
- 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 toxicity:
Oral - LD50 = > 5 mL/kg
Inhalatiin - LC50 = > 511 ppm
Dermal: LD50 = > 10 mL/kg
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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data considered reliable as copy of report received from the US EPA. Studies performed in accordance with 40 CFR part 716 for a chemical substance listed in Section 716.120 and processed for commercial purposes.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- According to Hagan, EC (1959) Acute Toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp 17-25. Comparison with
OECD Test 401 suggests that with the exception of the absence of a control group and analysis of the formulations procedures and study design were similar to those prescribed in this guideline - GLP compliance:
- not specified
- Remarks:
- GLP was just being introduced in 1978
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm Belvidere New Jersey USA
- Age at study initiation: Not reported
- Weight at study initiation: 139-164 g
- Fasting period before study: overnight prior to dosing
- Housing: assumed to be 5 animals/sex/group
- Diet (e.g. ad libitum): Wayne Animal Feeds available ad libitum except for overnight fast prior to dosing
- Water (e.g. ad libitum): ad libitum with possible exception of overnight prior to administration of test item
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: 16th March 1978To: 31st March 1978 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Test Item used as supplied
- Doses:
- 0.5, 1.0, 2.0 and 5.0 mL/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for signs of pharmacologic activity and/or toxicitys 1, 3, 6 and 24 hours post dose and daily thereafter for a total of 14 days. Weighed on intitiation and termination of the study
- Necropsy of survivors performed: Yes - Statistics:
- The LD50 was calculated, including the 95% confidence limits) where possible using the method of Litchfield and Wilcoxon (Litchfield JT and Wilcoxon F (1949) J Pharmacol. Exptl.Therap. pp96-99,
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 and 95% limits not calculable
- Mortality:
- One male animal given 5 mL/kg was sacrificed due to moribund condition on Day 5. Only signs observed from 24 hours after reciving the test item until sacrifice were slight depression and 28 g weight loss. No gross abnormalities at necropsy reported.
- Clinical signs:
- other: No clinical signs were oberved with the exception of 1 male dosed at 5.0 mL/kg that appeared slightly depressed within 24 hours of dosing and continued to Day 5 when it was humanely killed from the study.
- Gross pathology:
- With the exception of one male (dosed at 0.5 mL/kg) that was found to have fibrous tissue encasing the heart and lungs at necropsy, no abnormalities were found at gross necropsy of animals surviving the 14 day observation period.
- Other findings:
- None reported
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was found to be greater than 5.0 mL/kg.
- Executive summary:
Acute toxicity following administration of a single oral dose has been investigated in the rat. The LD50 was found to be in excess of 5 mL/kg body weight. At a density of 1.1181 the administered dose of 5 mL/kg equates to 5591 mg/kg body weight.
Reference
One male rat given 5 ml/kg was sacrificed on day 5 following mild depression and bodyweight loss. In the absence of similar effects in other animals given the same dose this death may not be due to the test item.
Dose Level Sex Dead/Dosed %
(ml/kg) 5M:5F 0/5:0/5 0
0.5 5M:5F 0/5:0/5 0
1.0 5M:5F 0/5:0/5 0
2.0 5M:5F 0/5:0/5 0
5.0 5M:5F 0/5:0/5 10
Result LD50: > 5.0 ml/kg
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 591 mg/kg bw
- Quality of whole database:
- Acute toxicity has been investigated in rats, mice and rabbits. All findings indicate the substance to exhibit low tow toxicity by the oral route
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Hazardous Substances Data Bank (HSDB®) is a toxicology data file on the National Library of Medicine's (NLM) Toxicology Data Network (TOXNET®). It focuses on the toxicology of potentially hazardous chemicals. It is enhanced with information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. All data are referenced and derived from a core set of books, government documents, technical reports and selected primary journal literature. HSDB is peer-reviewed by the Scientific Review Panel (SRP), a committee of experts in the major subject areas within the data bank's scope. HSDB is organized into individual chemical records, and contains over 5000 such records. This study was performed before the introduction of OECD guidelines and GLP. Limited details available on methodology.
- Principles of method if other than guideline:
- To determine the effects, in rats, of acute inhalation exposure
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation chamber
- Exposure chamber volume: No data
- Method of holding animals in test chamber: No data
- Source and rate of air: No data
- Method of conditioning air: No data
- System of generating particulates/aerosols: Air was bubbled through diethyl phthalate at 150 deg C
- Method of particle size determination: No data
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: No data - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 6 h
- Concentrations:
- 511 ppm (4.64 mg/L)
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data - Statistics:
- Not applicable
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- >= 511 ppm
- Exp. duration:
- 6 h
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- >= 4.64 mg/L air (nominal)
- Exp. duration:
- 6 h
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions in which this study was conducted LD50 was >511 ppm when administered by the inhalation route for 6 hours.
- Executive summary:
Under the conditions in which this study was conducted, no mortality occurred when rats were exposed to a saturated vapour of 511 ppm (4.64 mg/L) by the inhalation route for 6 hours.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 4 640 mg/m³ air
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:
- 16 - 31 March 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in 1978 before the introduction of GLP and OECD methodology.
- Qualifier:
- according to guideline
- Guideline:
- other: Hagan EC (1959) Acute toxicity in Appraisal of the Safety of chemicals in foods, drugs and cosmetics, pp 17-25
- Principles of method if other than guideline:
- Four groups of 3male and 3 female albino rats were given doses of 1.0, 2.0, 5.0 and 10.0 ml/kg, applied to the shaved mildly abraded skin under an occlusive patch for 24 h then observed for 14 days. The DEP was used as received. Animals were observed for signs of pharmacologic activity and toxicity 1, 3, 6 and 24 hours post application and daily thereafter for a total of 14 days. Animals sacrificed at the end of the 14 day observation period were subjected to a complete gross necropsy.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Age at study initiation: Not reported
- Weight at study initiation: Males: 140 - 170g; females: 154 - 178g
- Fasting period before study: no
- Housing: standard laboratory conditions
- Diet (e.g. ad libitum): Wayne animal feed
- Water (e.g. ad libitum): yes
- Acclimation period: yes, period not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard laboratory conditions
- Humidity (%): standard laboratory conditions
- Air changes (per hr): standard laboratory conditions
- Photoperiod (hrs dark / hrs light): standard laboratory conditions
IN-LIFE DATES: From: 16 March To: 31 March 1978 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Not reported
- % coverage: 10
- Type of wrap if used: gauze patches covered by an impermeable plastic wrapping
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0, 2.0, 5.0 or 10 ml/kg
- Concentration (if solution): 100% as supplied
- Constant volume or concentration used: no
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of exposure:
- 24 hours
- Doses:
- 1.0, 2.0, 5.0 or 10 mL/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs - 1, 3, 6 and 24 hours following dosing and daily thereafter for a total of 14 days. Body weight recorded at initiation and termination.
- Necropsy of survivors performed: yes - Statistics:
- Not required as there were no deaths and an LD 50 could not be calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Mortality:
- None in any dose group.
- Clinical signs:
- other: Skin slightly reddened in all animals when dressings removed
- Gross pathology:
- No abnormalitities detected
- Other findings:
- None reported
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 10 ml/kg
- Executive summary:
Acute toxicity following administration of a single dermal dose over a 24 hour period has been investigated in the rat. The LD50 was determined to be in excess of 10 mL/kg body weight. This equates to a dose level of 11181 mg/kg when corrected for density.
Reference
LD50 > 10 ml/kg
Dose Level Sex Dead/dosed % Mortality
(ml/kg) M:F
1.0 3:3 0/3:0/3 0:0
2.0 3:3 0/3:0/3 0:0
5.0 3:3 0/3:0/3 0:0
10.0 3:3 0/3:0/3 0:0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 11 181 mg/kg bw
Additional information
Acute toxicity following administration of a single oral dose has been investigated in the rat. The LD50 was found to be in excess of 5 mL/kg body weight (5591 mg/kg when corrected for density).
A poorly documented study by the inhalation route indicates no mortality to have occurred when rats were exposed to a saturated vapour of 511 ppm (4.64 mg/L) by the inhalation route for 6 hours.
Acute toxicity following administration of a single dermal dose over a 24 hour period has been investigated in the rat. The LD50 was determined to be in excess of 10 mL/kg body weight (11181 mg/kg when corrected for density).
Justification for selection of acute toxicity – oral endpoint
Best documented of the studies available
Justification for selection of acute toxicity – inhalation endpoint
Single study available
Justification for selection of acute toxicity – dermal endpoint
Single study available
Justification for classification or non-classification
Acute toxicity has been investigated by the oral and dermal and inhalation routes of exposure. The outcome of these studies does not indicate a justification for classification according to the criteria of Regulation (EC) No. 1272/2008.
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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