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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-353-5 | CAS number: 81-48-1
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Macrolex Violett B = C. I. Solvent Violet 13
(CAS No. 81-48-1)
DNELs (worker/general population)
I. Introduction:
Classification
Harmonized classification – Annex VI of Regulation (EC) (No 1272/2008 (CLP Regulation):
Not classified
Self-classification: Not classified
Known occupational exposure limit(s):
SCOEL: no data
TRGS 900: no data
MAK: no data
Remarks/Limitations
No remarks/limitations
DNELs (worker)
II: Conclusion - worker (systemic and local effects):
Route of exposure |
Local effect |
Systemic effect |
Dermal (long term) |
Moderate hazard band |
No hazard identified |
Dermal (long term) |
Moderate hazard band |
No hazard identified |
Inhalation (long term) |
No hazard identified |
No hazard identified |
Inhalation (short term) |
No hazard identified |
No hazard identified |
Hazard for eyes | No hazard identified |
III. DNEL systemic (worker)
In an OECD Guidelines 407 (Repeated Dose 28 Day Oral Toxicity Study in Rodents) three groups, each of five male and five female Wistar rats, received Macrolex Violett B at dose levels of 250, 500 or 1000 mg/kg bw/day by gavage, for twenty-eight consecutive days. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP).
Clinical signs, functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all animals at the end of the study.
All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed.
Based on the results of this study the No Observed Adverse Effect Level (NOAEL) for the oral administration of Macrolex Violett B over twenty eight consecutive days was 1000 mg/kg bw/day.
Long-term toxicity (oral, dermal, inhalation) – systemic effects (worker)
In the key study for oral toxicity a NOAEL = 1000 mg/kg bw/day was found (highest applied dose). No repeated dose studies for inhalation or dermal toxicity are available.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
Therefore:
Worker DNEL long-term for oral, dermal, inhalation exposure: no hazard identified
Short-term toxicity (oral, dermal, inhalation) – systemic effects (worker)
In the key study for oral toxicity a LD50 > 5000 mg/kg bw was found. No studies for acute inhalation or acute dermal toxicity are available.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
Therefore:
Worker DNEL short-term for oral, dermal, inhalation exposure: no hazard identified
Reproductive Toxicity – systemic effects (worker)
In an OECD guideline 421 (Reproduction/Developmental Toxicity Screening Test) Macrolex Violett B was administered by gavage to three groups, each of twelve male and twelve female Wistar rats, for approximately 6 weeks (males) and up to eight weeks (females) (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 250, 500 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Arachis oil BP) over the same period.
The study was performed to screen for potential adverse effects of the test item on reproduction, including offspring development to evaluate some endocrine disruptor relevant endpoints, and provides an initial hazard assessment for effect on reproduction.
The No Observed Adverse Effect Level (NOAEL) for the adult animals was considered to be 1000 mg/kg bw/day (the highest dosage tested). The No Observed Adverse Effect Level for reproduction and for the growth, development and survival of the offspring was also considered to be 1000 mg/kg bw/day.
In conclusion, no separate DNEL for toxicity to reproduction is required Macrolex Violett B, as the NOAEL for toxicity to reproduction is identical with the NOAEL for repeated-dose toxicity.
Conclusion on systemic DNEL:
For systemic effects:
no hazard identified
VII. DNEL local (worker)
Basis for delineation of the DNELs local (long and short term toxicity):
Irritation/corrosion
Skin irritation:
Several in vivo skin irritation/corrosion studies according or similar to OECD guideline 404 are available. The test items were not irritating to the skin.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Eye irritation:
Several in vivo eye irritation studies according or similar to OECD guideline 405 are available. The test items were not irritating to the eyes.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Sensitization
In an OECD 429 guideline study (Skin Sensitisation: Local Lymph Node Assay) the test item Macrolex Violett B was found to be a skin sensitiser and an EC3 value of 16.7% was derived.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Sens. 1B is justified.
Conclusion on local DNEL:
For local dermal effects:
According to the ECHA Guidance on information requirements and chemical safety assessment, Part E: Risk characterization, Version 3.0, May 2016 an allocation to the moderate hazard band is justified, based on the classification as Skin Sens. 1B.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNELs (general population)
V: Conclusion - general population (systemic and local effects):
Route of exposure |
Local effect |
Systemic effect |
Oral (long term) |
No hazard identified |
No hazard identified |
Oral (short term) |
No hazard identified |
No hazard identified |
Dermal (long term) |
Moderate hazard band |
No hazard identified |
Dermal (short term) |
Moderate hazard band |
No hazard identified |
Inhalation (long term) |
No hazard identified |
No hazard identifi |
Inhalation (long term) |
No hazard identified |
No hazard identified |
Hazard for eyes |
No hazard identified |
VI. DNEL systemic (general population)
In an OECD Guidelines 407 (Repeated Dose 28 Day Oral Toxicity Study in Rodents) three groups, each of five male and five female Wistar rats, received Macrolex Violett B at dose levels of 250, 500 or 1000 mg/kg bw/day by gavage, for twenty-eight consecutive days. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP).
Clinical signs, functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all animals at the end of the study.
All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed.
Based on the results of this study the No Observed Adverse Effect Level (NOAEL) for the oral administration of Macrolex Violett B over twenty eight consecutive days was 1000 mg/kg bw/day.
Long-term toxicity (oral, dermal, inhalation) – systemic effects (general population)
In the key study for oral toxicity a NOAEL = 1000 mg/kg bw/day was found (highest applied dose). No repeated dose studies for inhalation or dermal toxicity are available.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
Therefore:
General population DNEL long-term for oral, dermal, inhalation exposure: no hazard identified
Short-term toxicity (oral, dermal, inhalation) – systemic effects (general population)
In the key study for oral toxicity a LD50 > 5000 mg/kg bw was found. No studies for acute inhalation or acute dermal toxicity are available.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
Therefore:
General population DNEL short-term for oral, dermal, inhalation exposure: no hazard identified
Reproductive Toxicity – systemic effects (general population)
In an OECD guideline 421 (Reproduction/Developmental Toxicity Screening Test) Macrolex Violett B was administered by gavage to three groups, each of twelve male and twelve female Wistar rats, for approximately 6 weeks (males) and up to eight weeks (females) (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 250, 500 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Arachis oil BP) over the same period.
The study was performed to screen for potential adverse effects of the test item on reproduction, including offspring development to evaluate some endocrine disruptor relevant endpoints, and provides an initial hazard assessment for effect on reproduction.
The No Observed Adverse Effect Level (NOAEL) for the adult animals was considered to be 1000 mg/kg bw/day (the highest dosage tested). The No Observed Adverse Effect Level for reproduction and for the growth, development and survival of the offspring was also considered to be 1000 mg/kg bw/day.
In conclusion, no separate DNEL for toxicity to reproduction is required Macrolex Violett B, as the NOAEL for toxicity to reproduction is identical with the NOAEL for repeated-dose toxicity.
Conclusion on systemic DNEL:
For systemic effects:
no hazard identified
VII. DNEL local (general population)
Basis for delineation of the DNELs local (long and short term toxicity):
Irritation/corrosion
Skin irritation:
Several in vivo skin irritation/corrosion studies according or similar to OECD guideline 404 are available. The test items were not irritating to the skin.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Eye irritation:
Several in vivo eye irritation studies according or similar to OECD guideline 405 are available. The test items were not irritating to the eyes.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Sensitization
In an OECD 429 guideline study (Skin Sensitisation: Local Lymph Node Assay) the test item Macrolex Violett B was found to be a skin sensitiser and an EC3 value of 16.7% was derived.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Sens. 1B is justified.
Conclusion on local DNEL:
For local dermal effects:
According to the ECHA Guidance on information requirements and chemical safety assessment, Part E: Risk characterization, Version 3.0, May 2016 an allocation to the moderate hazard band is justified, based on the classification as Skin Sens. 1B.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)