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EC number: 279-317-3 | CAS number: 79828-43-6
- 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
FAT 40210 should be considered as not irritating to the skin and 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:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive testing conditions represent elevated testing conditions compared to OECD guideline 404
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 3.0 kg (approx. 15-16 weeks old). The acclimation was 4 days under laboratory conditions after veterinary examination. Body weights were measured on day 1 and at termination of test.
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with tap water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- on the test day 1, 0.5 g test article was applied to the intact skin of the shaved area. The test article was moistened with tap water.
- Duration of treatment / exposure:
- four hours
- Observation period:
- at 1, 24, 48, 72 hrs intervals after the removal of the dressing, gauze patch and test article.
- Number of animals:
- 1 male and 2 females
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10×10 cm). On test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area. It was covered with a 3.0×3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hrs after the application, the dressing was removed and the skin was flushed with lake warm tap water.
at 1,24,48,72 hrs after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None
- Other effects:
- In the area of application a black discoloration of the skin was observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40210/A was not found to cause a primary skin irritation when applied to intact rabbit skin.
- Executive summary:
A key study was performed to determine the skin irritation of FAT 40210/A according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).
There were 1 male and 2 female rabbits used in this test under the standard laboratory conditions. In the area of application a black discolouration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Under the conditions of this experiment, FAT 40210/A was found to cause a primary irritation score of 0 when applied to intact rabbit skin, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
Reference
None
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:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 2.7 kg (approx. 15-16 weeks old). The acclimation period was 4 days under laboratory conditions after veterinary examination.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The opposite eye was right untreated and served as the control
- Amount / concentration applied:
- 0.1 g per animal
- Duration of treatment / exposure:
- examination at 1, 24, 48, 72 h after administration with a single dose.
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- 1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. Body weights were measured on day 1 and at termination of test. The eyes of each animal were examined 1, 24, 48 and 72 h after administration. The corrosive properties of the test article and the colour of the treated eye were described and recorded.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 male and 2 females
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean of 1 male and 2 females
- Time point:
- other: 1 - 72 hrs
- Score:
- 0.5
- Max. score:
- 13
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corrosion of cornea was observed at any of the measuring intervals.
- Other effects:
- In the area of application a severe bluish-black discolouration of the cornea and conjunctivae was observed. No acute toxicity symptoms were observed and no mortality occurred during the test period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40210/A was found to cause a primary irritation scored of 0.5 when applied to the rabbit eye mucosa.
- Executive summary:
A key study was performed to determine the eye irritation of FAT 40210/A according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).
1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. A severe bluish-black discolouration of the cornea and conjunctivae of the treated eyes was observed which could be related to the colour proper to the test article. No corrosion was observed at any of the measuring intervals. The mean value of the scores for cornea, iris, conjunctivae chemosis is 0, otherwise the score for conjunctivae redness is 0.3 after 24 -72 h.
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. FAT 40210/A showed a primary irritation score of 0.5 when applied to the rabbit eye mucosa, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
A GLP-compliant study was performed to determine the skin irritation of FAT 40210 according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). 1 male and 2 female rabbits used in this test. In the area of application, a black discolouration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Another study was performed to determine the skin irritation potential of FAT 40210 according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). The 3 females were used in this test. The skin reactions observed were reversible until the end of the observation period on day 3. The mean value of individual reaction scores of erythema is 0.33, and the score of oedema is 0. Under the experimental conditions employed FAT 40210//B did not induced erythema and oedema reactions when applied to the shaved albino rabbit skin. Based on the results FAT 40210/A shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
The two other supporting studies conducted in 1979 and 1975 in accordance to the test procedure as described in Code of Federal Regulations also support the outcome that the substance should be considered as not irritating to the skin.
Eye irritation:
A GLP-compliant study was performed to determine the eye irritation of FAT 40210 according to OECD Guideline 405 (Acute Eye Irritation / Corrosion). The test substance was applied undiluted in the left eye of 1 male and 2 females rabbits. A severe bluish-black discolouration of the cornea and conjunctivae of the treated eyes was observed which could be related to the colour proper to the test article. No corrosion was observed at any of the measuring intervals. The mean value of the scores for cornea, iris, conjunctivae chemosis is 0, otherwise the score for conjunctivae redness is 0.3 after 24 -72 hrs. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. FAT 40210/a showed a primary irritation score of 0.5 when applied to the rabbit eye mucosa, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
Another study was performed to determine the skin irritation potential of FAT 40210 according to OECD Guideline 405(Acute Eye Irritation / Corrosion). The test performed on 3 females showed conjunctiva when applied into the conjunctival sac. No adverse effects were observed with cornea and iris of all animals. The eye reactions observed were reversible until the end of the observation period on day 7.
The test substance was tested for occular irritation potential in this study (1979) in accordance with Code of Federal Requlations, Title 16, Section 1500, 41. 100 mg test substance was instilled in the eye of 6 rabbits and observed for irritation parameters. The mean ocular irritation index obtained was 11. However, the scores obtained were below the thresholds required for classification, hence the test substance can be considered to be not irritating to the eyes as per the Regulation (EC) No. 1272/2008.
In a study conducted in 1975, the substance (Procion Black H-N) was tested for eye irritation in a study conducted according to Code of Federal Regulations, Title 16, Section 1500, 42. The scores obtained were 0, 0, 0.5 and 0.83 for corneal opacity, iris, conjunctival redness and chemosis respectively. Hence, it can be concluded that Procion Black H-N was negative for eye irritation, according to the definition given in the Code of Federal Regulations.
Based on the results FAT 40210/A shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).
Considering the data from skin and eye irritation/corrosion studies, it can be concluded that FAT 40210/A is non-irritating to skin and eye of rabbits. Hence not classified according to CLP Regulation (Regulation EC No. 1272/2008).
Justification for classification or non-classification
Based on the above stated assessment of the skin irritation potential of Reactive Black 8 the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European Parliament and of the Council.
Based on the above assessment of the eye irritation potential of Reactive Black 8 the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European Parliament and of the Council.
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