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EC number: 241-734-3 | CAS number: 17741-63-8
- 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
Several acute oral toxicity studies were performed, resulting in LD50 values of >5000 and >15000 mg/kg bw. In an acute dermal toxicity study (OECD guideline 402, GLP) no mortality occured and no signs of toxicity were observed. LD50 dermal is considered to be > 2000 mg/kg bw.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- 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: CERJ., 53940 Le Genest
- Weight at study initiation: 220-250 g (males), 170-200 g (females)
- Fasting period before study: 18 hours
- Housing : 10 animals per Makrolon SAFI 60/40 cm cage, with dust free white wood shavings
- Diet: UAR A04, 18 to 25 g (depending on age and weight of the animal)
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 g/100 mL
MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/100 g - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: animals were observed continuously on the first day after administration, they then remained in daily observation for 14 days
- Necropsy performed: yes, animals that died during the first day (8 hours) were dissected and their major organs (liver, spleen, kidneys, stomach, lung, heart) examined macroscopically. All organs with obvious macroscopic lesions were retained for further histological examination if necessary. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Immediately after administration of Violet Cromophtal B, animals are lethargic and their fur is ruffled.
- Interpretation of results:
- GHS criteria not met
Reference
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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Purity: 98.3%
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 243 - 203g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Remarks:
- suspension
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorso-lateral parts of the trunk
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.67 g/kg bw (paste)
- For solids, paste formed: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of systemic toxicity were observed in the animals.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
- Other findings:
- Violet discoloration of the skin at the application site (evaluation of erythema formation was not possible)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance (as suspension/paste in corn oil Ph.Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.
No mortality occurred.
No signs of systemic toxicity were observed in the animals.
The following test item-related local effects were recorded during the course of the study, local effects occurred within the first 3 days after administration:
- Violet discoloration of the skin at the application site (evaluation of erythema formation was not possible)
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
The mean body weight of the male animals increased within the normal range throughout the study period. In the female group 4 animals showed a stagnation or marginal loss of body weight during the first week, but body weights were in a normal range during the second week.
This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. Due to the fact that stagnation of body weight is commonly known for females dermally applied, this stagnation is considered to be unspecific. Accordingly, the acute dermal median lethal dose (LD50) was determined to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
In an acute oral toxicity study male and female Tif RAI rats were administered the test substance at dose levels of 1000, 3000, 10000 and 15000 mg/kg bw (5 animals per sex per dose group) by oral gavage. Sesame oil was used as vehicle. Dosing was followed by a 15 day observation period. At 1000 and 3000 mg/kg bw no clinical signs were observed. At 10000 and 15000 reduction in spontaneous motility, diarrhea and violett colored skin were observed. No mortality was reported. Therefore the LD50 of the test substance is > 15000 mg/kg bw.
In another acute oral toxicity study male and female Wistar rats were administered the test substance at a dose levels of 5000 mg/kg bw (10 animals per dose group) by oral gavage. Arachis oil was used as vehicle. Dosing was followed by a 14 day observation period. Immediately after dosing, animals are lethargic and their fur is ruffled. No mortality was reported. Therefore the LD50 of the test substance is > 5000 mg/kg bw.
In an acute dermal toxicity study (Limit Test), young adult Wistar rats were dermally exposed to a single dose of 2000 mg/kg bw of the test item to the clipped skin and covered by semi-occlusive dressing for 24 hours. No mortality occurred. No signs of systemic toxicity were observed in the animals. Violet discoloration of the skin at the application site (evaluation of erythema formation was not possible) was observed. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The mean body weight of the male animals increased within the normal range throughout the study period. In the female group 4 animals showed a stagnation or marginal loss of body weight during the first week, but body weights were in a normal range during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. Due to the fact that stagnation of body weight is commonly known for females dermally applied, this stagnation is considered to be unspecific. Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.
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