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EC number: 274-436-7 | CAS number: 70210-39-8
- 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
Reactive Red 066 was found to be not irritating to the skin as well as eyes.
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:
- 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- yes
- Remarks:
- Compared to today's guidelines apprasive and occlusive testing conditions have been used representing elevated testing conditions
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs,
- Housing: kept separately in V2A wire cages
- Diet: (NAFAG, Gossau SG, rabbit food) ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- other: polyethylene glycol
- Remarks:
- PEG 400
- Controls:
- not required
- Amount / concentration applied:
- Before application a 50 % polyethylene glycol trituration (PEG 400) was made. FAT 40063/A was applied to each side in quantities of 0.5 g.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- 6 rabbits (3 males/3 females)
- Details on study design:
- TEST SITE
- Area of exposure: left side of the body of rabbit
- Type of wrap if used: Gauze patch and covered with plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 72 h - Irritation parameter:
- erythema score
- Remarks:
- Intact and scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: within 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact and scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Scarified skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index of FAT 40063/A was 0.7
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40063/A is to be considered as a mild irritant to the skin of rabbits. According to the classification and labelling according to GHS system no classification and labelling is required.
- Executive summary:
The study was carried out to determine the primary-irritation index with the test substance (FAT 40063/A) on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. 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 40063/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, on the basis of the evaluation scheme. The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 h on the intact and slightly scarified skin. The primary irritation index was found to be 0.7, therefore, FAT 40063/A is to be considered as a mild irritant to the skin of rabbits.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 h on the intact and slightly scarified skin.
Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.
Individual Animal Score: Erythema
Animal Number |
Intact Skin |
Scarified skin |
||
|
24 h |
72 h |
24 h |
72 h |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
Individual Animal Score: Edema
Animal Number |
Intact Skin |
Scarified skin |
||
|
24 h |
72 h |
24 h |
72 h |
1 |
1 |
0 |
2 |
0 |
2 |
0 |
0 |
1 |
0 |
3 |
1 |
0 |
2 |
0 |
4 |
0 |
0 |
1 |
0 |
5 |
1 |
0 |
2 |
0 |
6 |
2 |
0 |
3 |
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:
- 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- yes
- Remarks:
- not rinsing treated eyes represents an elevated testing condition compared to today's standard guidelines
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Russian breed
- Housing: Housed separately in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as a control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three female rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Observation period (in vivo):
- After exposure the reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
- Number of animals or in vitro replicates:
- 6 rabbits (3 male and 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water.
- Time after start of exposure: about 30 seconds after treatment.
SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- Rinsed and not rinsed
- Basis:
- mean
- Remarks:
- Six rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Rinsed and not rinsed
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Eyes rinsed
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation index was found to be 1.3 for the conjunctival scores that have been fully reversible within 48 hours. In addition, it has to be mentioned that not rinsing treated eyes represents an elevated testing condition compared to today's standard guidelines. Remaining test material may cause continuous mechanical irritation and therefore altering the response to the chemical.
- Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40063/A is to be considered as a minimal irritant to the eye of rabbits.
- Executive summary:
FAT 40063/A was subjected to eye irritation test according to the procedure adopted described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.0 for the conjunctivae in case of rinsed eyes. Therefore, FAT 40063/A is to be considered as a non-irritant to the eye of rabbits.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
The total maximum score is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 0 for the cornea, 0 for the iris and 1.3 for the conjunctivae.
Individual animal score: eyes rinsed
Days after application | Rabbit 1 | Rabbit 2 | Rabbit 3 | ||||||
Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Individual animal score: eyes not rinsed
Days after Application | Rabbit 4 | Rabbit 5 | Rabbit 6 | ||||||
Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | |
1 | 0 | 0 | 8 | 0 | 0 | 12 | 0 | 0 | 6 |
2 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 6 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 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
The primary-irritation index of FAT 40063 was determined on the skin of the rabbits. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indices from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.7. Therefore, FAT 40063/A is to be considered as a mild irritant to the skin of rabbits.
FAT 40063/A was subjected to eye irritation test on 6 rabbits of the Russian breed. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 1.3 for the conjunctivae. Therefore, FAT 40063/A is to be considered as a minimal irritant to the eye of rabbits.
Justification for classification or non-classification
Based on the findings in the skin and irritation studies, the Reactive Red 066 is considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 as irritating to the skin as well as eye.
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.