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EC number: 276-882-8 | CAS number: 72828-69-4
- 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 21015/A is to be considered as a non- irritant to the skin and eyes of rabbits.
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:
- 30 May 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: New Zealand White
- Sex: male and female
- Age at study initiation (in days): 63 - 105 days
- Weight at study initiation: 2.60 kgs (males) and 2.58 kgs (females)
- Housing: Semi-barrier system
- Die: Styles-Oxoid commercial irradiated diet ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: 1 week
Animals:
Healthy New Zealand white rabbits (Porton strain) aged 9-15 weeks with average body weights of 2.60 Kgs. (M) and 2.58 Kgs. (F), bred on the premises and maintained under a semi-barrier system. Six rabbits (3M and 3F) were acclimatized in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (± 1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times. - Type of coverage:
- occlusive
- Preparation of test site:
- other: one side abraded and other side shaved only
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml; 0.75 ml of which was applied.
Dose: 0.5 g - Duration of treatment / exposure:
- After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h. The assessment of the macroscopic skin reaction was made according to the following grading system.
- Observation period:
- 72 h
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- Method:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 c.m. square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin. After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h. The assessment of the macroscopic skin reaction was made according to the following grading system. - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine skin irritation of FAT 21015/A in rabbits according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six animals with intact and abraded skin were used for this purpose. 10 g of the test compound was mixed uith 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad (conc:0.5 g). Slight erythema and very slight to moderate oedema were seen in 3/6 and 6/6 rabbits respectively 24 h after application of the compound. Very slight oedema was still present on 4/6 abraded sites only at 72 h. The primary irritation score was 1.3. However, the substance did not warrant classification according to the CLP (Regulation 1272/2008) criteria. Hence, FAT 21015/A is to be considered as a non-irritant to the skin of rabbits.
Reference
Individual Animal Score: Erythema
Animal Number |
Intact Skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
1 |
0 |
12 |
0 |
0 |
1 |
0 |
14 |
1 |
0 |
1 |
0 |
16 |
0 |
0 |
0 |
0 |
Individual Animal Score: Edema
Animal Number |
Intact Skin |
Abraded skin |
||
|
24 h |
72 h |
24 h |
72 h |
11 |
1 |
0 |
2 |
1 |
13 |
1 |
0 |
1 |
0 |
15 |
1 |
0 |
2 |
0 |
12 |
3 |
0 |
3 |
1 |
14 |
1 |
0 |
2 |
1 |
16 |
3 |
0 |
3 |
1 |
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:
- 06 June 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances. Labelling Act Sect. 191.1.2 (February 1965), with slight modification.
- Deviations:
- not specified
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals:
Healthy New Zealand White rabbits (Porton strain) aged 9-15 weeks with average body weights of 2.6.0 kgs. (M) and 2.58 kgs. (F), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 M and 3 F) were acclimatised in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (+/- 1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18 .00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The right eye served as a control.
- Duration of treatment / exposure:
- The eyelids were then held closed for 1 second after the application of test material. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Observation period (in vivo):
- The rabbits were examined 1, 24, 48 and 72 h after application of the.test compound and for any further period that was considered necessary.
- Number of animals or in vitro replicates:
- Six rabbits (3 males and 3 females).
- Details on study design:
- The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances. Labelling Act Sect. 191.1.2 (February 1965), with slight modification. The eyes of the experimental animals were examined and found normal prior to the test. 100 mg. of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes- of three of the rabbits with warm water for 1 minute. The rabbits were examined 1, 24, 48 and 72 hours after application of the.test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritant / corrosive response data:
- A very slight to moderate conjunctival reaction was noted in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours, and thereafter continued to do so slowly until all eyes were normal by day 10. A corneal reaction consisting of damage to the superficial epithelium was noted in 2/3 unwashed and 1/3 washed eyes. This was still present at 24 h in 1/3 unwashed eyes. There was very little difference in reactions between washed and unwashed eyes.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21015/A is considered to be a non-irritant to the eyes.
- Executive summary:
A key study was performed to determine the eye irritation potential of FAT 21015/A in rabbits. Six rabbits were used for this purpose. A very slight to moderate conjunctival reaction was noted in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours, and thereafter continued to do so slowly until all eyes were normal by day 10. A corneal reaction consisting of damage to the superficial epithelium was noted in 2/3 unwashed and 1/3 washed eyes. This was still present at 24 h in 1/3 unwashed eyes. There was very little difference in reactions between washed and unwashed eyes. However the mean scores for corneal opacity, iris, conjuctival redness and chemosis of individual animals did not fulfill the CLP criteria for classification. Hence, FAT 21015/A is considered to be a non-irritant to the eyes.
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 key study was performed to determine skin irritation of FAT 21015/A in rabbits according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six animals with intact and abraded skin were used for this purpose. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. Slight erythema and very slight to moderate oedema were seen in 3/6 and 6/6 rabbits respectively 24 hours after application of the compound. Very slight oedema was still present on 4/6 abraded sites only at 72 hours. The primary irritation score was 1.3. However, the substance did not warrant classification according to the CLP (Regulation 1272/2008) criteria. Hence, FAT 21015 is to be considered as a non-irritant to the skin of rabbits.
Eye Irritation:
A key study was performed to determine the eye irritation potential of FAT 21015/A in rabbits. Six rabbits were used for this purpose. A very slight to moderate conjunctival reaction was noted in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours, and thereafter continued to do so slowly until all eyes were normal by day 10. A corneal reaction consisting of damage to the superficial epithelium was noted in 2/3 unwashed and 1/3 washed eyes. This was still present at 24 hours in 1/3 unwashed eyes. There was very little difference in reactions between washed and unwashed eyes. However, the mean scores for corneal opacity, iris, conjuctival redness and chemosis of individual animals did not fulfill the CLP criteria for classification. Hence, FAT 21015 is considered to be a non-irritant to the eyes.
Justification for classification or non-classification
Based on the findings in the skin and eye irritation study Acid Yellow 079 does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin as well as eyes.
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