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EC number: 204-614-1 | CAS number: 123-28-4
- 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
OECD 401: LD50 >5000 mg/kg bw (no mortality)
OECD 402: LD50 >2000 mg/kg bw (no mortality)
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:
- 1982-08-03, 1982-08-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study, but without GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 163 - 184 g
- Fasting period before study: overnight prior to dosing
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: CMPS80
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 5000 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: daily (mortality and symptoms); on days 1, 7, 14, and at death (weight)
- Necropsy of survivors performed: yes - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- None.
- Clinical signs:
- other: Dyspnoea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6. The animals recovered within 11 days.
- Gross pathology:
- No compound related gross organ changes were observed.
Reference
Table 1:Body Weights (g) and Standard Deviation
Dose (mg/kg bw) |
Day 1 |
Day 7 |
Day 14 |
|
Males |
||
5000 |
179 (4.6) |
231 (7.9) |
271 (8.4) |
|
Females |
||
5000 |
171 (7.4) |
197 (7.9) |
213 (12.1) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
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:
- 1992-04-28, 1992-07-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study performed under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 84/449 EEC, B.3
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, Stein, Switzerland
- Weight at study initiation: 217 - 240 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet (ad libitum): NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: at least 10% of the body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw - 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 observation period following administration: 14 days
- Frequency of observations and weighing: daily (mortality, signs, and symptoms); immediately before application and on days 7 and 14 (weight)
- 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.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- None.
- Clinical signs:
- other: Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days.
- Gross pathology:
- No deviations from normal morphology were found.
Reference
Table 1:Body Weights (g) and Standard Deviation
Dose (mg/kg bw) |
Day 1 |
Day 7 |
Day 14 |
|
Males |
||
5000 |
234 (9.0) |
265 (6.3) |
296 (19.7) |
|
Females |
||
5000 |
223 (6.2) |
227 (12.5) |
239 ( 13.9) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Acute oral toxicity
In the available CIBA-Geigy (No. 820894, 1982) study the acute toxic effects of the test substance was investigated after a single oral administration to rats. The investigations were performed in accordance with the OECD-Guideline 401 (Limit test). The test substance was administered once orally via gavage to 5 male and 5 female rats (Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif) suspended in CMPS80 (dose volume was 20 mL/kg bw) at a dose of 5000 mg/kg bw. Body weight and body weight gains were determined before administration, 7 and 14 days after the administration (p.a.); clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied 14 days p.a.. Dyspnoea, ruffled fur and curved body position were observed directly after treatment and lasted up to day 11 p.a.. The animals gained body weight as expected. No animal died and no compound related gross organ changes were observed. The oral LD50, was determined to be > 5000 mg/kg body weight.
Acute inhalation toxicity
No data available. Considering exposure conditions, inhalative intake of the substance is low, because it is a melting point solid that is produced in the form of granula.
Acute dermal toxicity
In the available CIBA-Geigy (No. 924056, 1992) acute dermal toxicity study conducted according to the OECD Guideline 402 (Limit Test), young adult Tif: RAI f (SPF)-rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the unchanged test substance (skin of the back, covered by semi occlusive dressing) for 24 hours. The application area corresponds to at least 10% of body surface area. The animals were observed for 14 days.
Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. The animals gained body weight as expected. No deviations from normal morphology were found. Since no mortality occurred, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in rats.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.
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