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EC number: 404-910-2 | CAS number: 164578-14-7 PIGMENT ADDITIV C
- 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 after single oral application was tested in male and female rats, which received 2000 mg/kg bw (5 males, 5 females). All animals survived until the end of the study without showing any signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed. The LD50 value for acute oral toxicity is > 2000 mg/kg bw.
A single dermal application of the test item to 10 rats (5 males and 5 females) at a dose of 2000 mg/kg bw was associated with no mortality and neither clinical signs. The dermal LD50 was determined to be > 2000 mg/kg bw
The studies were carried out according to OECD guidelines 401 and 402.
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:
- Aug - Sept 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 24 Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 25. April 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe:WISKf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
males: 7 weeks
females: 8 weeks
- Weight at study initiation:
males: 182 g (175-186 g)
females: 177 g (163-185 g)
- Fasting period before study:
16 h before substance application and 3-4 h thereafter
- Housing: in fully air-conditioned rooms in Macrolon cages type 3, on softwood granulate in groups of 5 animals
- Diet (e.g. ad libitum): rat/mice diet Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 28. Aug. To: 11. Sept. 1989 - Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: homogeneity of suspension
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - 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 weighing: weekly
- clinical observation: 10, 30 60 min, 2, 4, 6 h after application, daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical symptoms reported
- Gross pathology:
- no changes observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From the acute oral toxicity study, a LD0 of 2000 mg/kg and a LD50 > 2000 mg/kg bwwas obtained.
- Executive summary:
Under the conditions of the present study, a single oral application of the substance to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to male and female rats, observed over a period of 14 days is: LD50 cut-off (rat): unclassified In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified. According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for toxicity and is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable without restrictions
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:
- Sept - Oct 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 24. Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 25. Apr. 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe:WISKf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
males: 8 weeks
females: 9 weeks
- Weight at study initiation:
males: 217 g (214-220 g)
females: 193 g (187-198 g)
- Housing: indiviudally in fully air-conditioned rooms in Macrolon cages type 3, on softwood granulate
- Diet (e.g. ad libitum): rat/mice diet Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 19. Sept. To: 3 Oct. 1989 - Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100
- Type of wrap if used: elastic gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 h after application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): miostened with PEG 400 (1 g test item + 1 mL PEG 400)
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- 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:
body weight: weekly
clinical signs: 30, 60 min, 2, 4, 6 h after application, thereafter daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical symptoms reported; applicattion sites were yellow colored
- Gross pathology:
- no changes observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.The dermal LD50 was determined to be > 2000 mg / kg body weight.
- Executive summary:
Under the conditions of the present study, a single dermal application of the substance to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of the test item after a single dermal administration to male and female rats, observed over a period of 14 days is:
LD50 > 2000 mg/kd bw; unclassified In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified. According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for toxicity and is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable without restrictions
Additional information
Justification for classification or non-classification
Due to the results described in the acute oral and dermal toxicity studies (LD50oral/dermal in rats > 2000 mg/kg bw) the substance does not have to be classified as acute toxic.
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