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EC number: 219-983-4 | CAS number: 2591-76-6
- 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
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:
- 1988-04-13 to 1988-04-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, scientifically acceptable study report; no GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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: Dr. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation: males: 193 g; females: 179 g
- Fasting period before study: Yes, 16 hours before administration.
- Housing: groupwise (5 animals per cage)
- Diet: ad libitum (Kliba Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum (tap water)
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64, 10.0, 21.5 g/100 mL (w/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 464, 1000 and 2150 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration (at least once each working day). A check of moribund or dead animals was made twice each working day and once on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 464 - < 1 000 mg/kg bw
- Mortality:
- No mortality was observed in the lowest dosing group. 4 males and all females died at 1000 mg/kg bw. All animals died in the highest dosing group.
- Clinical signs:
- other: dyspnea, apathy, abnormal position, staggering, twitching, extention, saltatory and flexion spasms, rolling convulsions, piloerection, exophthalamus (females only), salivation, poor general state
- Gross pathology:
- Animals that died: general congestion
Sacrificed animals: no pathologic findings noted
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 464 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1988-04-27 to 1988-05-11
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Only orientating information about the inhalation hazard.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BASF-Test (IRT = inhalation risk test):
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at the temperature chosen for vapor generation (50°C). Rats were exposed to the test substance vapors for 8 hours. Documentation of clinical signs was performed over the 7-day study period. - GLP compliance:
- no
- Test type:
- other: Inhalation hazard test
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: about 8 - 9 weeks
- Weight at study initiation (mean): males: 262 g, females: 188 g
- Housing: They were housed in groups of three in type D III wire mesh cages supplied by Becker & Co., without bedding.
- Diet: KLIBA 24-343-4 rat/mouse laboratory diet (10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland), ad libitum in the exposure-free period.
- Water: ad libitum in the exposure-free period
- Acclimation period: At least 5 days
- Animal identification: colour lines on the base of the tail
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30- 70 %
- Photoperiod: 12 hours dark/ 12 hours light - Route of administration:
- other: mixture of the vapour of the test substance and air
- Vehicle:
- other: unchanged
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus, filled volume: Glass bottle (fritted glass flask, pore-size 90 - 150 um, diameter 30 mm) filled to a height of 5 cm with the test substance
- Source and rate of air: compressed air, 200 L/h
- Treatment of exhaust air: Disposal
- Temperature in air chamber: Between 19 and 25 °C - Duration of exposure:
- 7 h
- Concentrations:
- The mean concentration of the test substance (calculated for a study duration of 7 hours) was 0.43 mg/L.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examinations took place each workday. Lethality was checked each day.
- Necropsy of survivors performed: yes - Mortality:
- No mortality was observed.
- Clinical signs:
- other: During exposure: intermittently breathing, increased masticatory movement, snout wiping After exposure: nothing abnormal detected
- Body weight:
- Not determined.
- Gross pathology:
- No treatment related effects were seen during necropsy.
Reference
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:
- 1988-05-10 to 1988-05-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, scientifically acceptable study report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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
- Source: Dr. K. Thomae GmbH,7950 Biberach, Germany
- Weight at study initiation (mean): males: 261 g, females: 222 g
- Housing: Single housing in stainless steel wire mesh cages, Typ DK-III (Becker & Co., Castrop-Rauxel)
- Diet: Standardized animal laboratory diet, ad libitum (Kliba-Labordiaet 343, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Water: Tap water ad libitum
- Acclimation period: For at least one week
- Animal identification: Identification of groups using cage cards
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours dark/ 12 hours light - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk (about 50 cm²)
- Type of wrap if used: Covered with a porous dressing (four layers absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application side with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2.29 mL/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of application, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Symptoms and local findings: no abnormalities
- Gross pathology:
- no pathologic findings noted
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity:
In an acute oral toxicity study (BASF 1988, 10A0172/881066) similar to OECD 401, groups of 5 Wistar rats per sex were given a single oral dose of the test item in CMC at doses of 464, 1000 and 2150 mg/kg bw and observed for 14 days. No mortality was observed in the lowest dosing group. 4 males and all females died at 1000 mg/kg bw. All animals died in the highest dosing group. Based on these results, the LD50 value of the test item is > 464 and < 1000 mg/kg bw.
Acute inhalation toxicity:
In an acute inhalation toxicity
study (BASF 1988, 10I0172/8887026), groups of six (3/sex) Wistar rats
were exposed to a mean test item concentration of 0.43 mg/L for 7 hours.
During the exposure period intermittently breathing, increased
masticatory movement and snout wiping was observed. After the exposure
time and within the observation period of 14 days no animals have died
and no abnormalities was observed. An LC50 could not be determined.
Acute dermal toxicity:
In an acute dermal toxicity study
(BASF 1988, 11A0172/881067) similar to OECD 402, groups of five Wistar
rats per sex were dermally exposed to a limit dose of 2000 mg/kg of the
unchanged test item. The test substance was applied to the dorsal and
dorsolateral parts of the trunk (about 50 cm²) and covered by
semi-occlusive dressing for 24 hours. The animals were observed for 14
days. No animals died and no abnormalities were observed within the
observation period. Thus, the LD50 vaule is > 2000 mg/kg.
Justification for selection of acute toxicity – oral endpoint
Only available study for this endpoint performed similar to guideline.
Justification for selection of acute toxicity – inhalation endpoint
Only available study for this endpoint performed.
Justification for selection of acute toxicity – dermal endpoint
Only available study for this endpoint performed similar to guideline.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014 as cat. 4, H302, harmful if swallowed.
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