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EC number: 278-859-8 | CAS number: 78181-99-4
- 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
In an acute oral toxicity study with a dye preparation containing 50% dye the LD50 value was determined to be 2700 mg/kg bw. In an acute dermal toxicity study the LD50 value of the dye was > 2000 mg/kg bw. The intraperitoneal injection with a dye preparation containing 50% dye indicated a LD50 value between 50 and 200 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:
- other: Comparable to guideline study with acceptable restrictions (non-GLP)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA & Hagemann
- Weight at study initiation: males 150 - 270 g, females 150 - 200 g
- Fasting period before study: 15 h - 20 h before administration
- Diet: Herilan MRH-Haltung; H. Eggersmann KG - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%, 31.6%, 26.1%, 21.5%, 14.7%, 10.0%
DOSE VOLUME APPLIED:
10 mL/kg bw - Doses:
- 5000, 3160, 2610, 2150, 1470, 1000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 700 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: interpolated value
- Mortality:
- The mortality incidences (sexes combined) were:
5000 mg/kg bw: 9/10
3160 mg/kg bw: 10/10
2610 mg/kg bw: 3/10
2150 mg/kg bw: 3/10
1470 mg/kg bw: 1/10
1000 mg/kg bw: 1/10
For details, see table below - Clinical signs:
- other: 5000 mg/kg bw: dyspnea, apathy, staggering, twitching, urine yellow, piloerection, exophthalmos, fascicular, twitching, compulsive gnawing, shortness of breath, poor general state 3160 mg/kg bw: dyspnea, apathy, abnormal position, staggering, salivation,
- Gross pathology:
- Animals that died: heart: acute dilatation; acute passive hyperemia; lungs: slightly edematized; liver: claycolored periphery involving about half of the area of the acinus, confluent in some animals; stomach: extensive bloody ulcerations in the glandular stomach (hemorrhagic corrosive gastritis); intestines: atony, diarrheal contents
Sacrificed animals: nothing abnormal found in the organs - Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information
Reference
Mortality:
Dose (mg/kg bw) |
5000 |
3160 |
2610 |
2150 |
1470 |
1000 |
|
||||||
Males: Number of animals |
5 |
5 |
5 |
5 |
5 |
5 |
Dead animals after: |
|
|||||
1 h |
4 |
4 |
2 |
0 |
1 |
0 |
1 d |
5 |
5 |
2 |
0 |
1 |
0 |
2 d |
5 |
5 |
2 |
0 |
1 |
0 |
7 d |
5 |
5 |
2 |
0 |
1 |
0 |
14 d |
5 |
5 |
2 |
0 |
1 |
0 |
|
||||||
Females: Number of animals |
5 |
5 |
5 |
5 |
5 |
5 |
Dead animals after: |
|
|||||
1 h |
3 |
5 |
1 |
1 |
0 |
0 |
1 d |
4 |
5 |
1 |
1 |
0 |
0 |
2 d |
4 |
5 |
1 |
3 |
0 |
1 |
7 d |
4 |
5 |
1 |
3 |
0 |
1 |
14 d |
4 |
5 |
1 |
3 |
0 |
1 |
Mean weight (g):
Dose (mg/kg bw) |
5000 |
3160 |
2610 |
2150 |
1470 |
1000 |
|
|
|||||||
Males: Beginning of test |
190 |
270 |
190 |
180 |
180 |
150 |
|
|
|||||||
After |
2-4 d |
|
|
198 |
203 |
209 |
164 |
7 d |
|
|
244 |
241 |
241 |
198 |
|
13 d |
|
|
282 |
273 |
277 |
213 |
|
|
|||||||
Females: Beginning of test |
170 |
200 |
180 |
150 |
160 |
160 |
|
|
|||||||
After |
2-4 d |
184 |
|
190 |
171 |
179 |
179 |
7 d |
210 |
|
214 |
187 |
194 |
193 |
|
13 d |
229 |
|
235 |
198 |
204 |
197 |
LD50 determination:
Doses (mg/kg bw) |
No. of animals |
Dead animals after 14 days |
Mortality (%) |
Doses used for calculation |
1000 |
10 |
1 |
10 |
|
1470 |
10 |
1 |
10 |
|
2150 |
10 |
3 |
30 |
|
2610 |
10 |
3 |
30 |
* |
3160 |
10 |
10 |
100 |
* |
5000 |
10 |
9 |
90 |
|
|
||||
LD50 about 2700 mg/kg bw (interpolated value) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 700 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- 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, Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks old, female animals approx. 12 weeks old)
- Weight at study initiation: Animals of comparable weight (mean ± SD: males 233 ± 10 g, females 203 ± 9.8 g)
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P) (SDS Special Diets Services, Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 p.m. - 6.00 a.m. / 6.00 a.m. - 6.00 p.m.) - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 40 cm²
- % coverage: at least 10% of the body surface area
- Type of wrap if used: an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 1.75 mL/kg bw
- Concentration: undiluted - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made at least once each workday. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: Scoring of skin findings (assessment according to Draize; individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times until the last day of observation). - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality and no systemic clinical signs
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination. Local effects: Due to the yellowish discoloration of the application area readings of skin redness could not be determined from study day 1 until study day 9 in all male animals, and fr
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity
In the key acute oral toxicity study (BASF AG, 1980, equivalent to OECD 401), groups of 5 Sprague-Dawley rats per dose level and sex were exposed by single oral gavage at dose levels of 1000, 1470, 2150, 2610, 3160 and 5000 mg/kg bw with a dye preparation (containing 50% dye and 50% acetic acid). Animals were observed for 14 days. Mortality incidence, clinical signs and body weights were assessed during the observation period. All survivors were necropsied at the end of the observation period and examined macroscopically. Oral administration of the dye preparartion resulted in 1/10, 1/10, 3/10, 3/10, 10/10 and 9/10 deaths at 1000, 1470, 2150, 2610, 3160 and 5000 mg/kg bw, respectively.
As general clinical signs dyspnea, apathy, urine yellow, shortness of breath and poor general state were noted for all groups. All animals surviving to the day of scheduled necropsy showed body weight gain. At necropsy, there were no macroscopic findings in survivors. The oral LD50 for the dye preparation was determined to be 2700 mg/kg bw (interpolated value) in male and female rats.
Acute dermal toxicity
In an acute dermal toxicity study (BASF SE/Bioassay GmbH, 2011, according to OECD 402) the potential of the test substance to exert systemic toxicity was examined in groups of 5 Wistar rats per sex that were semiocclusively exposed for 24 hours and then observed for 14 days. Mortality incidence, clinical signs and body weights were recorded at regular intervals. All survivors were necropsied and examined macroscopically at the end of the observation period. No animal died and no local or systemic clinical signs were observed. There was no test item related effect on body weight. No gross lesions were noted at necropsy. The identified LD50 value was > 2000 mg/kg bw in male and female rats.
Other route
In an acute toxicity study (BASF AG, 1980) a dye preparation (containing 50% dye and 50% acetic acid) was administered to 5 mice per sex via intraperitoneal injection at dose levels of 50, 200 or 700 mg/kg bw. Observation period was until day 14 following treatment. All animals of the mid and high dose group died. Clinical signs were observed like dyspnoe, apathy, staggering, tremor, exsiccosis twitching, convulsions, exophthalmos, shortness of breath and a poor general state. Gross pathology revealed staining of abdominal cavity in animals that died and slight intraabdominal agglutination in sacrificed animals. Based on the mortality incidences of 0/10, 10/10 and 10/10 noted at 50, 200 and 700 mg/kg bw, respectively, the LD50 for the i.p. route of exposure was considered to be between 50 and 200 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
only available reliable study
Justification for selection of acute toxicity – dermal endpoint
only available reliable study
Justification for classification or non-classification
Based on the results of all relevant acute toxicity studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).
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