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EC number: 228-055-8 | CAS number: 6104-30-9
- 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 > 10000 mg/kg bw (rat, males and females); BASF AG, 1967
Dermal:
LD50 > 2000 mg/kg bw (rat, male and female); BASF SE, 2008
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: post observation period 7 days, no data on strain.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- post observation period 7 days, no data on strain.
- GLP compliance:
- no
- 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
- Weight at study initiation: 126-218 g
no further data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The doses were applied as 10%, 16% or 30% preparations of the test substance in water
- Doses:
- 800, 1000, 1600, 3200, 6400, 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Group-wise documentation of clinical signs was performed over the 7 day study period.
Body weight was determined before the start of the study only, as it was needed for determination of dose.
- Necropsy of survivors performed: yes
- Other examinations performed: The clinical signs and findings were reported in summary form . - Statistics:
- On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper .
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: 800-1600 mg/kg bw: no symptoms 3200-10000 mg/kg bw: piloerection and tachypnoea
- Gross pathology:
- Four animals showed chronic bronchitis and bronchi ectases, all other animals without findings in the organs . Necropsy was
performed by a pathologist .
Reference
Results are given as dead animals/total number of animals at this dose
at 24 h, 48 h and 7 days after dosing:
800 mg/kg bw: 0/10, 0/10, 0/10
1000 mg/kg bw: 0/10, 0/10, 0/10
1600 mg/kg bw: 0/10, 0/10, 0/10
3200 mg/kg bw: 0/10, 0/10, 0/10
6400 mg/kg bw: 0/10, 0/10, 0/10
10000 mg/kg bw: 0/10, 0/10, 0/10
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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
- Source: Charles River Wiga GmbH
- Age at study initiation: male animals approx. 8 - 9 weeks, female animals approx. 12 - 13 weeks
- Weight at study initiation: males: 232-255 g; females: 206-224 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26 °C
- Humidity (%): 20-80 %
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- % coverage: at least 10 % of the body
- Type of wrap if used: semi-occlusive dressing (the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG
and Fixomull stretch (adhesive fleece), Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing of the application site with warm water.
- Time after start of exposure: after 24 hours of exposure
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 g/kg (50% testsubstance)
- Concentration (if solution): 50 g/100 ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,gross pathology, assessment of the skin reactions - Statistics:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No systemic clinical observations were observed during clinical examination and no local effects (skin) were observed
- Gross pathology:
- No macroscopic pathologic findings were noted in the animals (5 males and 5 females) examined on the last day of observation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: oral
There is no study available, which is performed according to the current guideline. Nevertheless the study with rats (no data on strain, only 7 days post observation) is considered of sufficient and good quality to allow the evaluation of this endpoint. The LD50 in rats (5 animals/sex/dose) was > 10 000 mg/kg bw (IBDU, purity 90 – 96 %). The only clinical symptom noted was tachypnoea and piloerection at concentrations of 3200 mg/kg bw and higher. Doses of 800, 1000, 1600, 3200, 6400 and 10000 mg/kg bw were tested (BASF AG, 1967).
Acute toxicity: inhalation
The results from an inhalation risk test (with outdated methodology and lack of proper analytical verification of the test atmosphere concentration), where the rats were exposed to the dusty parts (predominant size range of 2 -20 µm) of the test substance for 8 hours at a mean nominal concentration of 2.6 mg/l indicated, that the test substance is not toxic by the inhalation route as no deaths occurred and no clinical signs were noted.
Acute toxicity: dermal
A GLP dermal toxicity study was conducted according to OECD guideline 402 with rats (Wistar strain, 14 days of observation). The dermal LD50 in rats (5 animals/sex) was > 2000 mg/kg bw (IBDU, purity 90.3%). There were no unusual observations of any kind at the limit dose of 2000 mg/kg bw (BASF AG, 2008).
Justification for classification or non-classification
No classification and labeling is required, as the oral LD50 was greater than 10000 mg/kg and the dermal LD50 was greater than 2000 mg/kg with no mortality observed in both studies.
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