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EC number: 911-358-0 | CAS number: -
- 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
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- 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
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- 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
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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- 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
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:
The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase. No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.
The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.
Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing a modified Buehler and Klecak method on guinea pigs. - GLP compliance:
- not specified
- Type of study:
- other: a modified Buehler and Klecak method
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- - Name of test material : Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone
- Substance type : Organic
- Physical state : Solid - Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: 1.epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10% (0.1mL)
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- Route:
- other: 1.epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10.0%, 5.0%, and 2.50%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: 10
- Control group: no data
- Site: shaved left flanks of ten albino guinea pigs over a 1.8-cm circular area.
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two week rest period
- Exposure period: 24 hours
- Test groups: 10
- Control group:
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 10.0%, 5.0%, and 2.50%
- Evaluation (hr after challenge): 24 hour and 48 hours - Positive control substance(s):
- yes
- Remarks:
- 0.5% DNCB
- Reading:
- other: 1-2.1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10.0%, 5.0%, and 2.50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema/edema was observed after 24 and 48 hours post-application
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- No erythema/edema was observed after 24 and 48 hours post-application
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test material Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) was considered to be not sensitizing to the skin.
- Executive summary:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:
The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase. No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.
The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.
Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Reference
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale
0 = no reaction,
1 = slight reaction,
2 = moderate reaction and
3 = severe reaction.
A positive reaction was defined as an erythema/edema
value during the challenge phase of at least one skin grade higher than during the last induction phase
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0). The studies are as mentioned below:
The peer reviewed journal conducted skin sensitization study for read across chemicals in albino guinea pig using modified Buehler and Klecak method for open Epicutaneous testing. In this test, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the each test material were applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the each test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase. No erythema/edema was observed after 24 and 48 hours post-application. Hence the test chemical was considered as not sensitizing to the guinea pigs’ skin.
The above result was further supported by another experimental study conducted by same peer reviewed journal for another similar read across chemical. The study was followed by the same method as per mentioned in above study in albino guinea pigs. Since no erythema/edema was observed after 24 and 48 hours post-application, the test chemical was considered as not sensitizing to the guinea pigs’ skin.
Based on the above summarized studies for target chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Reaction mass of 1,4-bis(butylamino)anthraquinone and 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-(butylamino)-4-(methylamino)anthraquinone and 1-(butylamino)-4-[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone (EC No: 911-358-0) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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