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EC number: 944-283-7 | 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
ACID YELLOW 104 is neither a skin nor an eye irritant.
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:
- supporting study
- Study period:
- 1974
- 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:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food arid Drug Officials (AFDO).
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: V2A wire cages
- Diet: standard rabbit food ad libitum - NAFAG, Gossau SG
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- other: polyethylene glycol (50 %)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g of the test material were applied to the prepared abraded and intact skin.
- Duration of treatment / exposure:
- The gauze patches were removed 24 hours after the application.
- Observation period:
- The reaction of the skin was appraised upon patch removal and after 72 hours later.
- Number of animals:
- 3 male and 3 female
- Details on study design:
- A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- on intact as well as abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- on intact as well as abraded skin
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20041/A is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No irritation was found with the intact as well as abraded skin throughout the exposure period. Hence, FAT 20041/A can be classified as a non-irritant to the skin of rabbits.
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:
- 1980
- 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:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: 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.
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: housed individually in metal cages, numbered by ear tags
- Diet: standard rabbit food ad libitum - NAFAG, No. 814, Gossau SG
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2° C
- Humidity: 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- The test material in an amount of 0.1 g was inserted
- Duration of treatment / exposure:
- The test material in an amount of 0.1 g 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.
- Observation period (in vivo):
- The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.
- Duration of post- treatment incubation (in vitro):
- None
- Details on study design:
- None
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20041/B can be considered as not an eye irritant.
- Executive summary:
The eye irritation potential of the test substance was evaluated in a study conducted according to 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 3 male and 3 female adult New Zealand White rabbits. The test material in an amount of 0.1 g 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. No irritation was seen when the exposed eyes were examined for corneal opacity, effects on iris and conjuntival redness. However mild chemosis was seen in 2 of 6 exposed animals, which was fully reversible within 72 hours. Hence, the scores obtained in this study do not fulfil the classification criteria for eye irritation as required by Regulation (EC) No. 1272/2008. Hence, FAT 20041/B can be considered as not an eye irritant.
Reference
Table: Eye irritation – Individual scores
Animal No. |
Rinsed/ not rinsed |
Corneal opacity |
Iris |
Conjunctival redness |
Chemosis |
24 hours |
|||||
200 |
not rinsed |
0 |
0 |
0 |
2 |
201 |
not rinsed |
0 |
0 |
0 |
1 |
202 |
not rinsed |
0 |
0 |
0 |
0 |
203 |
rinsed |
0 |
0 |
0 |
0 |
204 |
rinsed |
0 |
0 |
0 |
0 |
205 |
rinsed |
0 |
0 |
0 |
0 |
48 hours |
|||||
200 |
not rinsed |
0 |
0 |
0 |
1 |
201 |
not rinsed |
0 |
0 |
0 |
0 |
202 |
not rinsed |
0 |
0 |
0 |
0 |
203 |
rinsed |
0 |
0 |
0 |
0 |
204 |
rinsed |
0 |
0 |
0 |
0 |
205 |
rinsed |
0 |
0 |
0 |
0 |
72 hours |
|||||
200 |
not rinsed |
0 |
0 |
0 |
0 |
201 |
not rinsed |
0 |
0 |
0 |
0 |
202 |
not rinsed |
0 |
0 |
0 |
0 |
203 |
rinsed |
0 |
0 |
0 |
0 |
204 |
rinsed |
0 |
0 |
0 |
0 |
205 |
rinsed |
0 |
0 |
0 |
0 |
Day 7 |
|||||
200 |
not rinsed |
0 |
0 |
0 |
0 |
201 |
not rinsed |
0 |
0 |
0 |
0 |
202 |
not rinsed |
0 |
0 |
0 |
0 |
203 |
rinsed |
0 |
0 |
0 |
0 |
204 |
rinsed |
0 |
0 |
0 |
0 |
205 |
rinsed |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
A key study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits.The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. However, abraded skin is an elevated testing condition and the results obtained with abraded skin normally do not have to be taken into account for hazard assessment. According to the EC classification of the results obtained, FAT 20041/A can be classified as non-irritant in albino rabbits.
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits.The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No irritation was found with the intact as well as abraded skin throughout the exposure period. Hence, FAT 20041/A can be classified as a non-irritant to the skin of rabbits.
Eye:
The eye irritation potential of the test substance was evaluated in a study conducted according to 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 3 male and 3 female adult New Zealand White rabbits. The test material in an amount of 0.1 g 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. No irritation was seen when the exposed eyes were examinedfor corneal opacity, effects on iris and conjuntival redness. However mild chemosis was seen in 2 of 6 exposed animals, which was fully reversible within 72 hours. Hence, the scores obtained in this study do not fulfil the classification criteria for eye irritation as required by Regulation (EC) No. 1272/2008. Hence, FAT 20041/B can be considered as not an eye irritant.
Similarly, other supporting study conducted with FAT 20041/A also supports the conclusion that the substance is not a eye irritant.
Justification for classification or non-classification
Based on the available studies, FAT 20041 does not need to be classified as per the CLP (Regulation 1272/2008) criteria.
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