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EC number: 258-110-1 | CAS number: 52697-38-8
- 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
The substance shows a low toxicity. The oral LD50 lies above 5000 mg/kh body weight.
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:
- weight of evidence
- Study period:
- July/August 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WINKELMANN, Borchen
- Age at study initiation: 9-14 weeks
- Weight at study initiation: Mean weight - Males; 155-167g, Females; 150-160g
- Fasting period before study: from about 16 hours before till 4 hours after application
- Housing: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (± 1.5°C)
- Humidity (%): 60 (± 5 %)
- Photoperiod (hrs dark / hrs light): 12 hours daily - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
- Executive summary:
Acute oral toxicity testing of Disperse Violet 93:1 in the rat yielded a median lethal dose (LD50) above 5000 mg/kg body weight in both male and female animals. No lethality occurred after application of 5000 mg/kg body weight. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 21. June to 05.July 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- as published under Directive 84/449/EWG
- GLP compliance:
- yes
- 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
- Strain Bor: WISW (SPF Cpb)
- Source: WINKELMANN, Borchen
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Mean weight - Males; 170g (189-199g), Females; 170g (169-190g)
- Fasting period before study: from about 16 hours before
- Housing: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin® 1324 Pellets), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (± 2°C)
- Humidity (%): 50 (± 10 %)
- Photoperiod (hrs dark / hrs light): 12 hours daily - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: Development of body weight was not impaired.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
- Other findings:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
- Executive summary:
Acute oral toxicity testing of Disperse Violet 93:1 in the rat yielded a median lethal dose (LD50) above 5000 mg/kg body weight in both male and female animals. No lethality occurred after application of 5000 mg/kg body weight. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977/1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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:
- other: Alderley Park specific pathogen free (SPF) albino rats (Supplied by the Animal Breeding Unit, Imperial Chemical Industries PLC, Pharmaceuticals Division, Macclesfield, Cheshire)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Alderley Park, specific pathogen free (SPF) albino rats
- Weight at study initiation: 150-175 g
- Females (if applicable) nulliparous and non-pregnant
- Housing: group
Justification for the choice: the rat is the preferred rodent species for this study
ENVIRONMENTAL CONDITIONS
- Humidity (%): relative humidity 50-60
- Air changes (per hr): 10-20
- Temperature (°C): RT 19-23 °C
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 2x10 ml/kg bw
- Justification for choice of vehicle: not water souble - Doses:
- 5000 mg/kg bw.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations fequently on first day thereafter daily; weighing: Day 0, 2, 5, 7, 14
- Necropsy of survivors performed: yes - Statistics:
- The acute oral LD50 was estimated from the mortality data.
- Preliminary study:
- 1 male + 1 female at 5000 mg/kg bw with 14 day observation period - without effect
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No
- Clinical signs:
- other: discoloured urine and faeces
- Gross pathology:
- no effects
- Other findings:
- No signs of toxicity were observed in any animal during the study period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study, Disperse Violet 93:1 was given orally by gavage at a dose level of 5000 mg/kg bw to 3 male and 3 female rats. No adverse effects were seen, no rats died. The test substance has hence an oral LD50 of more the 5000 mg/kg bw in male and female rats.
- Executive summary:
In an acute oral toxicity study, Disperse Violet 93:1 (Br) was given at a single dose level of 5000 mg/kg bw to 3 male and 3 female rats.
On the day of dosing the animals were observed for signs of systemic toxicity once between 30 and 90 minutes and again between 4 and 5 hours after dosing. Subsequent observations were made once daily up to Day 15.
No deaths or signs of toxicity were noted throughout the study period. Body weight development was regular. Hence, Disperse Violet 93:1 (Br) has an oral LD50 of more than 5000 mg/kg bw in male and female rats.
Referenceopen allclose all
No signs of toxicity were observed in any animal during the study period.
Therefore, Disperce Violet 93:1 (Br) has an LD50 to male and female rats in excess of 5000 mg/kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across is based on the same physico-chemical properties, a close structural similarity and the same mechanism of action during use processes.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: Disperse Blue 79:1
Substance Name: 2,2’-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
EC Number: 222-813-1
CAS Number: 3618-72-2
- Target: Disperse Violer 93:1
Substance Name: N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number: 258-110-1
CAS Number: 52697-38-8
3. ANALOGUE APPROACH JUSTIFICATION
see attachment section 13
4. DATA MATRIX
see attachment section 13 - Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- The test was conducted according to an internal procedure.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Remarks:
- saturated with test item
- Details on inhalation exposure:
- Inhalation by means of inhalation of test substance saturated atmosphere for 8 h. To achieve saturation, air was fed through an approx. 5 cm deep layer of the test substance.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- saturation concentration
- No. of animals per sex per dose:
- 12 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy - Statistics:
- NA
- Preliminary study:
- NA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LC0
- Based on:
- test mat.
- Remarks:
- 40% purity
- Exp. duration:
- 8 h
- Remarks on result:
- other: no effect at saturation concentration
- Mortality:
- no deaths
- Clinical signs:
- other: no effects
- Body weight:
- no data
- Gross pathology:
- no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, no mortality was observed in the treated rats.
- Executive summary:
A study was conducted to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereby observed for 14 d. Under the study conditions, no mortality was observed in the treated rats (Munk, 1977).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read across is based on the same physico-chemical properties, a close structural similarity and the same mechanism of action during use processes.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: Disperse Blue 79:1
Substance Name: 2,2’-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate
EC Number: 222-813-1
CAS Number: 3618-72-2
- Target: Disperse Violer 93:1
Substance Name: N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
EC Number: 258-110-1
CAS Number: 52697-38-8
3. ANALOGUE APPROACH JUSTIFICATION
see attachment section 13
4. DATA MATRIX
see attachment section 13 - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Weight range: 244 to 264 g
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface
- Type of wrap if used: aluminium foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm (40-50°C) dilute soap solution, rinsing in clean warm water
- Time after start of exposure: 24 h
- Duration of exposure:
- 24 hours
- Doses:
- 5 mL/kg bw
- No. of animals per sex per dose:
- 10 male rats
- Control animals:
- yes
- Remarks:
- treated with water
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations: clinical signs daily; body weight weekly
- Necropsy of survivors performed: yes - Statistics:
- NA
- Preliminary study:
- NA
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: slight lethargy and piloerection
- Gross pathology:
- congestion of the lungs ond pale or uneven col.ouration of the liver and kidneys. Five rats had haemorrhage of.the subcutaneous blood vessels of the treated areas.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, acute dermal LD50 of the test substance in rats was determined to be greater than 5 mL/kg bw.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the test substance according to a method equivalent to OECD Guideline 402. No mortality was observed in the treated rats. According to the study conditions, the acute dermal LD50 of the test substance was determined to be greater than 5 mL/kg bw (Davies, 1974).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In three separate studies, the acute oral toxicity of Disperse Violet 93:1 in the rat was tested at a dose level of 5000 mg/kg body weight in 3 or 5 male and 3 or 5 female rats according to or equivalent to OECD Test Guideline 401. No lethality occurred after application of 5000 mg/kg body weight. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Based on the results obtained in this study the median lethal dose value (LD50) of the substance for the male and female rat is greater than 5000 mg/kg body weight.
A study was conducted to determine the acute inhalation toxicity of the test substance (Structural Analogue 03) according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereafter observed for 14 days. Under the study conditions, no mortality was observed in the treated rats.
A study was conducted to determine the acute dermal toxicity of the test substance according (Structural Analogue 03) to a method equivalent to OECD Guideline 402. No mortality was observed in the treated rats. According to the study conditions, the acute dermal LD50 of the test substance was determined to be greater than 5 mL/kg bw.
Justification for classification or non-classification
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.