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EC number: 201-346-7 | CAS number: 81-39-0
- 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 oral toxicological investigations were conducted in an old study after administration of Macrolex Red 5B to male Wistar rats.
After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings.
The discriminating dose is >1175 mg/m3 in an OECD TG 403 complient recent acute inhalation study. The mean mass median aerodynamic diameter (MMAD) was 11.18 µm and the mean geometric standard deviation (GSD) was 2.24. Animals exposed to the test item did not reveal any clinical symptoms. Nonetheless test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery. No toxicological relevant test item-related changes in incremental body weight gain were observed. Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups. Mortality did not occur at 1175 mg/m3. No gross pathological findings were found in animals exposed to the test item. In summary, the maximum attainable aerosol concentration was tested in this study.
No acute dermal toxicity study is available. Based on the low oral toxicity and no irritation potential to skin or eyes, no dermal toxicity is anticipated.
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Acute toxicological investigations were conducted after oral administration of 5000 mg/kg MACROLEX Red 5B to 10 male Wistar rats.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- physical state: solid
Appearance: red powder - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules (supplier: Firma Bogner, Solingen) at a room temperature of 22 ± 2 •c, with artificial lighting from 6 a.m. to 6 p.m., relative humidity of about 50 ± 10% and approximately ten air changes per hour.
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer.
- Details on oral exposure:
- The substance was suspended in Lutrol (Polyethylene glykol 400) at room temperature on a magnetic stirrer. It was then administered intragastrically to 10 male animals each by way of a rigid metal gavage at a constant application volume of 20 ml/kg body weight. The test substance was formulated in the application medium immediately before administration.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During
inspections, the type, onset, duration, and intensity of clinical signs were recorded and any dead animals were removed. The time of deat of the deceased was documented.
The animals were weighed before administration (day 0) and at the end of the observation period. The application volume for each individual animal was based on its body weight just before application. - Statistics:
- not applied
- Sex:
- male
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- noe deaths
- Clinical signs:
- other: Aftersingle administration of 5000 mg/kg MACROLEX Red 5B no clinical signs were observed.
- Gross pathology:
- no noticeable gross pathological findings
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Acute toxicological investigations were conducted in an old study after oral administration of Macrolex Red 5B to male Wistar rats.
After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
- Specific details on test material used for the study:
- Test item: Macrolex Rot 58
Purity: 99.4 %
Aggregation state: solid powder, red
Batch number: CHC002 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- A study on the acute inhalation toxicity of Macrolex Rot 58 (henceforward referred to as test item) on rats has been conducted in accordance with OECD Test Guideline no. 403 (2009). Test procedures were adapted so as to comply also with the Method B.2 of the Annex to Regulation (EC) No 440/2008, and especially OECD Guidance Document no. 39 (2009). One group of rats, consisting of 3 male and 3 female animals, was nose-only exposed to the solid aerosol of the test item at the maximum attainable concentration of 1175 mg/m3. Efforts have been made to meet the limit test criteria of the OECD Test Guideline no. 403 (2009). Animals were exposed to 1175 mg/m3 of an aerosol with a mean MMAD of 11.18 µm and mean GSD of 2.24. The generation of a test atmosphere with higher concentrations as well as lower MMAD was from a technical point of view not feasible, also using two other dust
generators. Furthermore micronization was not feasible as well. Thus 1175 mg/m3 was considered to be the highest technically feasible concentration with lowest achievable MMAD. Rats exposed to dry conditioned air only under otherwise identical circumstances served as controls. - Route of administration:
- inhalation: mist
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 11.18 µm
- Geometric standard deviation (GSD):
- 2.24
- Remark on MMAD/GSD:
- The generation of a test atmosphere with higher concentrations as well as lower MMAD was from a technical point of view not feasible, also using two other dust generators. Furthermore micronization was not feasible as well. Thus 1175 mg/m3 was considered to be the highest technically feasible concentration with lowest achievable MMAD.
- Details on inhalation exposure:
- Three male and three female rats were simultaneously exposed under nose-only conditions for 4 h. This procedure is in compliance with the limit test described in OECD Test Guideline No. 403 and OECD GD#39 (2009).
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1175 mg/m3
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- yes
- Details on study design:
- This procedure is in compliance with the limit test described in OECD Test Guideline No. 403 and OECD GD#39 (2009).
- Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 1 175 mg/m³ air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no
- Clinical signs:
- other: Test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery.
- Body weight:
- No toxicological relevant test item-related changes in incremental body weight gain were observed.
- Gross pathology:
- No gross pathological findings were found in animals exposed to the test item.
- Other findings:
- Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The mean mass median aerodynamic diameter (MMAD) was 11.18 µm and the mean geometric standard deviation (GSD) was 2.24. Animals exposed to the test item did not reveal any clinical symptoms. Nonetheless test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery. No toxicological relevant test item-related changes in incremental body weight gain were observed. Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups. Mortality did not occur at 1175 mg/m3. No gross pathological findings were found in animals exposed to the test item. In summary, the maximum attainable aerosol concentration was tested in this study.
The discriminating dose is >1175 mg/m3
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 1 175 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No acute toxicity was seen in acute oral or inhalation toxicity studies. Classification is not warranted.
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