Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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 Red 195 is to be considered as a non-irritant to the skin and eye 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:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2380 t o 2650 g
- Housing: Housed individually in metal cages
- Diet: rat food (Nafag, No. 814, Gossau) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: A control gauze patch was applied to the contralateral flank of the animals, which were exposed to the test substance on right flanks.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- Three female rabbits
- Details on study design:
- TEST SITE
An area of at least 36 cm² was shaved on both flanks of the animals. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with distilled water.
The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. - 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
- Irritant / corrosive response data:
- No reactions were observed.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20042/D can be classified as non-irritant in albino rabbits
- Executive summary:
An in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to OECD Guideline No. 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation. Hence,FAT 20042/D can be classified as non-irritant in albino 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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993 - Species:
- rabbit
- Strain:
- other: Chbb:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH,Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2030 to 2610 g.
- Housing: Housed individually in metal cages
- Diet: Nafag, No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day
IN-LIFE DATES: From: To: January 11, 1994 to February 15, 1994 - Vehicle:
- not specified
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- - Amount(s) applied: 100 mg
- Duration of treatment / exposure:
- Unwashed eye: unspecified (not rinsed after single instillation)
- Observation period (in vivo):
- The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- Three animals (one males and two females)
- Details on study design:
- PROCEDURE:
The test article was applied with a spatula. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked dailyfor systemic symptoms and mortality (only findings reported).
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D according to the OECD scoring system. In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation. The irritant/corrosive potency of FAT 20042/D was classified according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC. - Irritation parameter:
- conjunctivae score
- Basis:
- animal: 824
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 824
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: 824
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 824
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 086
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 086
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 086
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 086
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 025
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 025
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 025
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 025
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- The mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, and 0 for the conjunctivae.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20042/D is classified as non-irritant to the eyes of rabbit.
- Executive summary:
- Acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 20042/D in the albino rabbit eye and the associated mucous membranes. This test was based on OECD Guideline 405. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. Because reactions were observed till 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The mean values of the readings at 24, 48 and 72 hours after instillation were below the threshold of significance. Also changes observed were fully reversible within 7 days. Therefore, as per the Regulation (EC) No. 1272/2008, FAT 20042/D is not an eye irritant.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
Acid Red 195 was investigated in in vivo studies for the potential to cause skin irritation.
The key study (1993) was conducted according to OECD Guideline No. 404 using rabbits. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation. Hence, FAT 20042/D can be classified as non-irritant in albino rabbits.
An in vivo study (1979) was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six animals (3/sex). Each test site received 0.5 g of substance on a 2.5 cm2 gauze pad for 24 h under occlusive conditions. No erythema or odema was seen in all animals involving both intact and abraded sites 24 as well as 72 h after application of the test substance. Under the study conditions, the test substance was considered to be non-irritating to skin.
In another supporting study (1974), skin irritation potential of the test substance was evaluated according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six rabbits (3/sex). Each test site received 0.5 g of substance on a 2.5 cm2gauze pad for 24 and 72 h under occlusive conditions. Test sites were assessed for erythema and oedema at 24 and 72 h after patch removal. No erythema and odema was seen with both intact and abraded sites in all animals 24 and 72 h after application of the test substance. Under the study conditions, the test substance was considered to be non-irritating to skin.
The available studies indicate that Acid Red 195 did not lead to skin irritation on intact as well as abraded skin.
Eye:
Acid Red 195 was investigated in in vivo studies for the potential to cause eye irritation.
The key study was based on OECD Guideline 405. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. Because reactions were observed till 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The mean values of the readings at 24, 48 and 72 hours after instillation were below the threshold of significance. Also changes observed were fully reversible within 7 days. Therefore, as per the Regulation (EC) No. 1272/2008, FAT 20042/D is not an eye irritant.
In a supporting study (1979) conducted according to guideline proposed in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), FAT 20042/B in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits. The irritation score was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, it was concluded that, FAT 20042/B did not lead to irritation when applied to the rabbit eye mucosa.
In another supporting study (1974) again conucted according to guideline proposed in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), amounts of 0.1 g of FAT 20042/A were introduced into the conjunctival sac of the left eye of rabbits with a spatula. The irritation index was found to be 0 for the cornea, 0 for the iris and 2.4 for the conjunctivae. Therefore, the test substance did induce minimal irritation in eyes as seen with the scores for conjunctiva, when eyes were not rinsed. However the scores fail to fulfil the criteria for classification as specified by the Regulation (EC) No. 1272/2008, hence FAT 20042/A is not considered to be an eye irritant.
Based on the above discussion, Acid Red 195 can be considered as not irritating to the eyes.
Justification for classification or non-classification
Based on the above stated assessment, Acid Red 195 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according to CLP [Regulation (EC) No 1272/2008].
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.