Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-888-1 | CAS number: 1052-38-6
- 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
LD50, oral, rat, (m/f) > 2698 mg/kg bw (BASF, 1979)
LC50, inhalation, rat (m/f) > 5610 mg/m3 (BASF, 1978)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 08. Feb. 1978 - 17. Mar. 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with acceptable restrictions performed on analogue substance 1
- Principles of method if other than guideline:
- In principle, the methods described in OECD Guideline 401 were used.
5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7 day study period. The clinical signs and findings were reported in summary form. 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. - GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 210 (mean), female: 160 (mean)
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
5000 mg/kg: 50%
3160 mg/kg: 31.6%
2150 mg/kg: 21.5%
1470 mg/kg: 14.7% - Doses:
- 5000mg/kg, 3160 mg/kg, 2150 mg/kg, 1470 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 800 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 698 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 5000 mg/kg: 1 male and 1 female died within 5 days, 1 male and 3 females died within 6 days and 1 male and 1 female died on day 7.
3160 mg/kg: 1 male died within day 3 and 1 within day 6. 1 female died on day 7.
2150 mg/kg: No mortality was observed.
1470 mg/kg: 1 female died within 4 days. - Clinical signs:
- other: Poor general state in the 1st week of the study. Occurrence of death and loss of weight at the end of the 1st week of the study. 5000 mg/kg: Immediately after the application: apathy, irregular respiration, tumbling, spastic gait, discoloured urine (oran
- Gross pathology:
- Animals that died spontaneously:
5000 mg/kg: Animals that died within 2 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained brown-yellow; intestine: single cases of a state indicative of preceding diarrhea. Animals that died within 4 days: intestine: dark brown contents; liver, kidneys, heart and lung: dark complexion, peritoneum and subcutis: stained brown-yellow. Animals that died within 6 days: cadaverous, probably overstaining of organs.
3160 mg/kg: animals that died within 3 days: Heart: acute dilatation on the right; acute congestive hyperemia; adipose tissue/muscles: stained orange; animals that died within 6 days: conspicuously grey musculature; lung: wet, fleshy, hyperemia; liver: despite blood-filled conspicuous centrilobular pattern visible. Animals that died within 7 days: heart: dilatation of the ventricle; congestive hyperemia; muscles: despite cadaverous conditions grey-yellow staining observable.
Sacrificed animals:
5000 mg/kg: Kidneys: conspicuously dark.
3160, 2150 and 1470 mg/kg: No abnormalities were observed. - Interpretation of results:
- not classified
- Remarks:
- Migrated information according to CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw of tested material, i.e. 2698 mg/kg bw active ingredient.
- Executive summary:
The analogue substance 1 was tested for acute toxicity oral rats following a method similar to OECD401. The doses were 5000, 3160, 2150 and 1470 mg/kg bw /day by gavage for 5 animals/dose. Under the experimental conditions the substance showed LC50 ca 3800 mg/kg bw, i.e. 2698 mg/kg bw of active ingredient
Reference
Mortality:
Dose: mg/kg | gender | 1h | 24h | 48h | 7 days | 14 days |
5000 | Male | 0/5 | 0/5 | 0/5 | 3/5 | 3/5 |
5000 | Female | 0/5 | 0/5 | 0/5 | 5/5 | 5/5 |
3160 | Male | 0/5 | 0/5 | 0/5 | 2/5 | 2/5 |
3160 | Female | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 |
2150 | Male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
2150 | Female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
1470 | Male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
1470 | Female | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 |
Weight in g (mean):
Dose: mg/kg | gender | 0 days | 2 days | 7 days | 13 days | |
5000 | Male | 210 | 215 | 180 | 228 | |
5000 | Female | 160 | 162 | - | - | |
3160 | Male | 210 | 218 | 184 | 249 | |
3160 | Female | 180 | 180 | 162 | 208 | |
2150 | Male | 210 | 208 | 234 | 268 | |
2150 | Female | 180 | 173 | 185 | 217 | |
1470 | Male | 170 | 195 | 216 | 253 | |
1470 | Female | 180 | 176 | 191 | 213 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 698 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 19. Apr 1978 - 05. May 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with acceptable restrictions performed on analogue substance 1
- Principles of method if other than guideline:
- Inhalation Hazard Test: The test was performed equivalent or similar to the method described in H.F. Smyth et. al. Am. Ind. Hyg. Ass. 23, 95-107 (1962). Inhalation of an atmosphere enriched at room temperature with the dust of the test material by rats for 7 hours. The documentation of clinical signs was performed over a period of 7 days.
- GLP compliance:
- no
- Test type:
- other: Inhalation hazard test.
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 185 g (mean), female: 221 g (mean) - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- pressure in air chamber: 1.013 bar - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- ca. 7 h
- Concentrations:
- 7.91 mg/l (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.61 mg/L air
- Based on:
- act. ingr.
- Exp. duration:
- 7 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: 7 h post exposure occured irregular respiration, bloody nose discharge and scrubby fur. 6 days post exposure all animals were considered as normal.
- Gross pathology:
- No abnormalities were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.
- Executive summary:
Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 610 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Valid in vivo data are available for the assessment of the acute toxicity of the test substance over two exposure patterns, oral and inhalation. In particular: inhalation exposure pattern is covered by a study on analogue substance 1 while oral toxicity is assessed by two studies, one on the substance itself, the other on analogue substance 1.
Acute toxicity oral.
Mortality was observed at the highest dose used in the oral test on analogue substance 1 (i.e. 2698 mg/kg bw > 2000 mg/kg bw limit dose for classification) after one week and it was not observed in the test performed on the substance itself, even though at a smaller concentration, i.e. LD50 (LD0) > 1120 mg/kg bw (recalculated based on the active ingredient). Even though the substance itself was tested at doses below the classification limits, no clinical adverse effects were observed during the whole test and gross patology did not show any substance related effect. Therefore the substance toxicity can be supposed very low. Based on the read across justification the value found for analogue substance 1 can be used for classification purposes.
Acute toxicity inhalation
No mortality was observed during the inhalation test at the concentration of LC50 (LC0)> 5610 mg/m3.
Based on the read across considerations and the testing results, Solvent Brown 41 is not considered toxic after single acute oral or inhalative exposure.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be 2698 mg/kg bw in the chosen reference test, therefore, the test substance is not classified for Acute toxicity by oral exposure.
For Acute toxicity inhalation route (mists, mg/l)
Category 1: ATE <= 0.05
Category 2: 0.05 < ATE <= 0.5
Category 3: 0.5 < ATE <= 1
Category 4: 1 < ATE <= 5
The LC50 of the test substance was determined to be 5610 mg/m3 (or 5.6 mg/l), therefore, the test substance is not classified for Acute toxicity by inhalation exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.