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EC number: 274-395-5 | CAS number: 70209-97-1
- 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
Skin Irritation:
Primary skin irritation study in rabbits with FAT 20075/B was conducted according to OECD guideline 404 and EU method B.4 in accordance with GLP. The purpose of this primary skin irritation study was to assess the possible irritation potential when single doses of test article were placed on dorsal skin of each of three young adult New Zealand rabbits (1 male and 2 female). On test Day 1, total 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The duration of treatment was 4 h. There were no clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. FAT 20075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.11 edema. Reversible red staining by the test article of the treated skin was observed. The body weight gain of all rabbits was within the normal range of variability. Based on these observations and on the referred classification criteria, FAT 20075/B is classified as "non irritating" to rabbit skin.
Eye Irritation:
Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. 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 (1 male and 2 female) 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. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 1995 to 26 October 1995
- 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:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C)protected from sunlight.
- Stability under storage conditions:
stable at storage conditions
- Stability of the test substance in the water:
not specified; excluded from the Statement of Compliance - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.6 kg; females: 2.8 - 3.0 kg
- Housing: 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, Batch 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70 % (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) /12 hours dark
IN LIFE PHASE: 23 October 1995 to 26 October 1995 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with bi-distilled water. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after removal of dressing, gauze patch and test article.
- Number of animals:
- 1 male
2 females - Details on study design:
- TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- % coverage: 3.0 cm x 3.0 cm patch of surgical gauze
- Type of wrap if used: Elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm tap water
- Time after start of exposure: after 4 h - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the 72 hours observation period.
- Other effects:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20075/B is classified as "non irritating" to rabbit skin.
- Executive summary:
Primary skin irritation study in rabbits with FAT 20075/B was conducted according to OECD guideline 404 and EU method B.4 in accordance with GLP. The purpose of this primary skin irritation study was to assess the possible irritation potential when single doses of test article were placed on dorsal skin of each of three young adult New Zealand rabbits (1 male and 2 female). The test article was moistened with bi-distilled water before application. Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. Only those animals with no signs of skin injury or irritation were used in the test.
On test Day 1, total 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing.
The duration of treatment was 4 h. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time. The skin reaction was assessed at approximately 1, 24, 48 and 72 h after the removal of the dressing, gauze patch and test article.
There were no clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. FAT 20'075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.11 edema. Reversible red staining by the test article of the treated skin was observed. The body weight gain of all rabbits was within the normal range of variability.
Based on these observations and on the referred classification criteria, FAT 20075/B is classified as "non irritating" to rabbit skin.
Reference
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
IRRITATION
FAT 20075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.11 edema.
COLORATION
Reversible red staining by the test article of the treated skin was observed.
CORROSION
No irreversible alteration of the treated skin were observed nor were corrosive effects evident on the skin.
BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.
Skin Irritation Score:
Time period | Animal No. | Sex | Erythema | Edema |
24 h | 31 | Male | 0 | 0 |
32 | Female | 0 | 1 | |
33 | Female | 0 | 0 | |
48 h | 31 | Male | 0 | 0 |
32 | Female | 0 | 0 | |
33 | Female | 0 | 0 | |
72 h | 31 | Male | 0 | 0 |
32 | Female | 0 | 0 | |
33 | Female | 0 | 0 |
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:
- 30 October 1995 to 06 November 1995
- 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:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C) protected from sunlight
- Stability under storage conditions:
stable at storage conditions - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 13 weeks
- Weight at study initiation: male : 2.2 kg; females: 2.2 - 2.3 kg
- Housing: 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, Batch no. 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark
IN-LIFE DATES: From: October 25, 1995 To: December 12, 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- - Swelling of the conjunctivae was reversible after seven days.
- Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
- Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20075/B is classified as "not irritating" to the rabbit eye.
- Executive summary:
Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. 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 (1 male and 2 female) 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 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. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. It was found to be 1.11, when applied to the conjunctival sac of the rabbit eye. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.
Reference
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.
IRRITATION
FAT 20'075/B showed a primary irritation score of: 1.11, when applied to the conjunctival sac of the rabbit eye. Slight-to-moderate swelling of the conjunctivae was noted in all animals but was reversible after seven days. Slight-to-moderate watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
COLORATION
Light red or red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.
CORROSION
No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS
The body weight of the animals was within the normal range of variability.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings in the skin and eye irritation study, Acid Red 252 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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