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EC number: 276-634-9 | CAS number: 72391-23-2
- 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
Based on two in-vivo studies Acid Violet 109 is not irritating to skin or eye.
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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN.Nr. 400047.32
- Expiration date of the lot/batch: December 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight.
- Stability under test conditions: Stable at storage conditions
- Stability of the test substance in the solvent/vehicle: Up to 24 hours bidistilled water - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65,D-88397 Biberach/Riss
- Age at study initiation:15 weeks
- Housing: Placed Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet : Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no.75/97)
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: Four days under test conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): As a solid, approximately 0.5 g (per animal) of the test article was weighed and then moistened with bidistilled water before application. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 2 females
- Details on study design:
- Preparation:
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm) and the skin of the animals was examined.
TEST SITE
- Area of exposure: On the day of treatment, the test article was applied to approximately 6 cm2 of the intact skin of the clipped area.
- Type of wrap if used: It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
If evident, corrosive or staining properties of the test article were described and recorded. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal No 7, 8 and 9
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal No 7, 8 and 9
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Other effects:
- VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed
BODY WEIGHTS
The body weight of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21016/C is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits according to OECD 404 and EU B4 guidelines. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 h) were used in calculating the respective mean values for erythema and edema. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 h and then dividing by the number of figures. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused violet or light violet staining of the treated skin. No irritating or corrosive effects were noted on the exposed skin of any animal at any measuring interval. Hence, FAT 21016/C is considered to be "not irritating" to rabbit skin.
Reference
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:
- 1997
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN. Nr. 400047.32
- Expiration date of the lot/batch: December 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight
- Stability of the test substance in the solvent/vehicle: Stable at storage conditions - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Chbb:NZW(SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
100 mg of the test compound were instilled into the conjunctival sac of the left eye. - Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 female)
- Details on study design:
- SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland). - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.22. Slight reddening and slight swelling of the conjunctivae, as well as slight to moderate watery discharge and hyperemia of the scleral blood vessels were observed. All findings were reversible after 48 hours. A corneal reaction consisting of damage to the superficial epithelium was seen in one unwashed eye (NC.12) at 24 hours only. Staining of the conjunctivae by the compound was noted in all unwashed eyes up to 72 hours.
- Other effects:
- VIABILITY/MORTALITY AND CLINICAL SIGNS: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred
COLORATION: No staining of the cornea, sclera or conjunctivae by the test article was observed.
CORROSION: No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS: The body weight of all rabbits were considered to be within the normal range of variability. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21016/C is considered to be "not irritating" to the eye.
- Executive summary:
FAT 21016/A was subjected to eye irritation test accrding to following guidelines: Directive 92/69 EEC, B.5 and OECD 405 guideline and in accordance to GLP. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.22 (max. 13). Reddening and swelling of the conjunctivae as well as watery discharge and hyperemia of the scleral blood vessels were observed. However these findings were reversible after 48 hours. Cornea and iris were not affected throghout the study. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. In conclusion, FAT 21016/C is considered to be "not irritating" to the eye.
Reference
Body weights:
Animal Nr | Sex | First day of Acclimatisation | First day of treatment | Last day of Observation |
19 | Male | 2842 | 3030 | 3102 |
20 | Female | 3035 | 3330 | 3392 |
21 | Female | 2942 | 3179 | 3259 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The skin irritation potential of Acid Violet 109 was assesed in several in vivo studies.In a study conducted with FAT 21016/C (1997), considered as key study, three rabbits were assessed according to OECD Guideline 404. No irritating or corrosive effects were noted on the exposed skin of any animal at any measuring interval. Hence, FAT 21016/C is considered to be "not irritating" to rabbit skin. The above outcome was also supported by the findings of the studies conducted with FAT 21016/A (1975) and FAT 20200/A (1978).
Eye irritation:
The eye irritation potential of Acid Volet 109 was assesed in several in vivo studies. In the study conducted with FAT 21016/C (1997), considered as key study, three rabbits were assessed
according to OECD Guideline 404. The primary
irritation score was 0.22 (max. 13). Reddening and swelling of the
conjunctivae as well as watery discharge and hyperemia of the scleral
blood vessels were observed. However, these findings were reversible
after 48 hours. Cornea and iris were not affected throghout the study.
No staining of the cornea, sclera or conjunctivae of the treated eyes by
the test article was observed. No corrosion was observed at any of the
measuring intervals. In conclusion, FAT 21016/C is considered to be "not
irritating" to the eye. The above outcome was also supported by the
findings of the studies conducted with FAT 21016/A (1975) and FAT
20200/A (1978).
Justification for classification or non-classification
Acid Violet 109 was found to be not irritating to skin and eyes of rabbits, hence it does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (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.
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