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EC number: 915-761-2 | 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
- 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
Basic Red 046 Methylsulfate was considered to cause no irritation when applied to intact and abraded rabbit skin, however leads to irreversible effects on the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June, 1980 to 23 June, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: The Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Test material received: May 2, 1980
Additional identification: Physical appearance: liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 6 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages numbered by ear tags, were kept at a constant room temperature of 22±2 °C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 females
- Details on study design:
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin.
The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 31016/F was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
Skin irritation potential of FAT 31016/F was evaluated in a study conducted according to the procedure described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female adult New Zealand White rabbits bred weighing 2 to 3 kgs. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). No irritation was observed with the intact or the abraded skin. Hence, the primary irritation index was calculated to be 0. Based on the findings of the study, FAT 31016/F was found to cause no irritation when applied to intact and abraded rabbit skin.
Reference
Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema
based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
No irritation was observed with the intact or the abraded skin. Hence, the primary irritation index was calculated to be 0.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June, 1980 to 23 June, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Test material received May 2, 1980
Additional identification: Physical appearance: liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22±2 °C, at a relative humidity of 55±10 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.89
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: treated eye not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed after 30 seconds
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days for the rabbit with symptoms
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation; 2 out of 3 rabbits had no irritation reaction in iris at any observation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Treated eye rinsed 30 seconds after instillation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Instillation of FAT 31016/F in eye, leads to irreversible effects on the eyes.
- Executive summary:
Eye irritation potential of FAT 31016/F was evaluated in a study conducted as per the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female New Zealand White rabbits. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥3 for 2 out of 3 rabbits which did not receive rinsing. Also the iris was scored to be =2 in all 3 rabbits which did not receive rinsing. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.
Reference
Primary irritation index
Time after exposure days |
mean reaction score |
|||||
unrinsed eyes (A) |
rinsed eyes (B) |
|||||
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
|
1 |
26.7 |
10 |
18 |
11.7 |
1.7 |
15.3 |
2 |
40 |
10 |
18.7 |
25 |
3.3 |
17.3 |
3 |
40 |
10 |
18.7 |
30 |
3.3 |
17.3 |
4 |
46.7 |
10 |
18.7 |
30 |
3.3 |
17.2 |
7 |
46.7 |
10 |
18.7 |
30 |
3.3 |
14.7 |
subtotal |
200.1 |
50 |
92.8 |
126.7 |
14.9 |
81.9 |
total |
342.9 |
223.5 |
primary irritation index in unrinsed eyes
A = 342.9 : 5 = 68.6
primary irritation index in rinsed eyes
B = 223.5 : 5 = 44.7
effect of rinsing
R = A/B = 68.6/44.7 = 1.5
Scores for individual rabbits
Animal no.s |
|
scores |
||||
24 h |
48 h |
72 h |
Day 4 |
Day 5 |
||
127 (Unrinsed) |
Corneal opacity |
3 |
3 |
3 |
4 |
4 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
4 |
4 |
4 |
4 |
|
128 (Unrinsed) |
Corneal opacity |
2 |
3 |
3 |
3 |
3 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
2 |
3 |
3 |
3 |
|
Chemosis |
3 |
3 |
3 |
3 |
3 |
|
129 (Unrinsed) |
Corneal opacity |
3 |
3 |
3 |
3 |
3 |
Iris |
2 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
3 |
3 |
3 |
3 |
|
130 (Rinsed) |
Corneal opacity |
1 |
1 |
1 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
2 |
2 |
2 |
2 |
2 |
|
Chemosis |
3 |
3 |
3 |
3 |
2 |
|
131 (Rinsed) |
Corneal opacity |
1 |
1 |
1 |
1 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctival redness |
2 |
2 |
2 |
2 |
2 |
|
Chemosis |
3 |
3 |
3 |
3 |
2 |
|
132 (Rinsed) |
Corneal opacity |
2 |
3 |
4 |
4 |
4 |
Iris |
1 |
2 |
2 |
2 |
2 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
3 |
4 |
4 |
4 |
4 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Skin irritation potential of Basic Red 046 Methylsulfate (FAT 31016/F, purity 36 %) was evaluated in a study conducted according to the procedure described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female adult New Zealand White rabbits bred weighing 2 to 3 kgs. In this study, no irritation was observed with the intact or the abraded skin. Hence, the primary irritation index was calculated to be 0. Based on the findings of the study, FAT 31016/F was considered to cause no irritation when applied to intact and abraded rabbit skin.
Eye irritation
Eye irritation potential of Basic Red 046 Methylsulfate (FAT 31016/F, purity 36 %) was evaluated in a study conducted as per the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female New Zealand White rabbits. In this study, the corneal opacity was scored to be ≥3 for 2 out of 3 rabbits which did not receive rinsing. Also the iris was scored to be =2 in all 3 rabbits which did not receive rinsing. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.
Justification for classification or non-classification
Basic Red 046 Methylsulfate does not warrant classification for skin irritation, however needs to be classified as a substance causing irreversible effects on eye (category 1) as per the Regulation EC No. 1272/2008 (CLP) criteria.
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.
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