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EC number: 211-199-0 | CAS number: 633-96-5
- 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
not eye irritant for rabbits
not skin irritant for 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or test system and environmental conditions:
- Age: 12-16 weeks
Body weight: average 2.16 kg for males and 2.24 for females.
Source: Hylyne Commercial rabbits Lt
Acclimation: 1 week
Caged singly in an experimental room mainteined at a temperature of 16°C and with a humidity of 50-70%.
Animals were exposed to artificial light for 10 hours daily from 8-18 hours.
Commercial diet, Labsure Christopher Hill Group, was fed ad libitum.
Sterile filtered water was available at all the times. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 10 g of the test compound was mixed with 12ml of deionised water to make a solution of 20ml.
1 ml of which was applied to each test site on a 2.5cm square gauze pad.
These were couered with aluminium foil secured with "TFanspore" surgical tape. The test sites were then couered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours and up to 14 days after treatment
- Number of animals:
- 6, 3 for each sex
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10%
of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application
of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep
to penetrate the stratum corneum but not to damage the dermis. The left hand sit« remained intact. - Irritation parameter:
- erythema score
- Basis:
- animal: 11,12
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 13, 15,14 and 16
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 15,12 and 14
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
- Executive summary:
The primary irritation score was assessed following the Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965).
The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under CLP classification.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. (sea appendix I).The tested substance is considered to be irritant for the rabbits eyes.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or tissues and environmental conditions:
- Animals age: 12-16 weeks
Average body weights of 2.16 kgs. (SS) and 2.24 kgs.
Source: commercial supplier (Hylyne Commercial Rabbits Ltd.).
Acclimation in the test area for one week prior to the start of the trial.
The rabbits were caged singly in an experimental room maintained at a temperature of 16 C and a relative humidity of 50 - 70%.
Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.
A commercial diet (Labsure, Christopher Hill Group) was fed ad lib.
Sterile filtered water was available at all times. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye serves as control
- Amount / concentration applied:
- 100 mg of the test substance
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- up to 10 days
- Number of animals or in vitro replicates:
- 3 males / 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: after 30 seconds the compounds was flushed out of three of the rabbits with 200 ml of warm water.
SCORING SYSTEM: The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics"
page 51, published by the Association of Food and Drug Officials of the U.S.A.
TOOL USED TO ASSESS SCORE: fluorescein (Fluorets - Smith & Nephew Pharmaceutical Limited) was used as an aid in assessing corneal damage. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Reversibility:
- fully reversible within: 2 days
- Remarks:
- waahed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Reversibility:
- fully reversible within: 2 days
- Remarks:
- washed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 1 and 2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 4 and 5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 3 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 2,4 and 5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Conjunctiva:Slight/mild reactions were seen in 3/3 unwashed and 3/3 washed eyes 1 hour after compound application. All the eyes had
improved at 24 hours. At 72 hours 2/3 washed eyes were normal, at 6 days 1/3 washed and 1/3 unwashed eyes were normal. All eyes were normal
at 10 days.
Cornea: Slight opacity with damage to the surface epithelium was seen at 1 hour in 3/3 yashed and 3/3 unwashed eyes. 1/3 washed and 1/3
unwashed eyes were normal at 24 hours, 2/3 washed and 1/3 unwashed eyes were normal at 48 hours. All eyes were normal at 72 hours.
Iris: 2/3 unwashed and 1/3 washed eyes showed increased folding at 24 hours only.
Some of the unwashed eyes showed slightly more severe reactions than those of washed eyes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested substance needs to be considered not irritant for rabbits eyes under Regulation 1272/2008.
- Executive summary:
The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. (sea appendix I).
The tested substance is considered to be not irritant for the rabbits eyes based on the results under Regulation 1272/2008.
Reference
Irritation parameter | Basis | Time point | Score | Max. score | Reversibility |
cornea score | animal #1 Number 11 | 24, 48 and 72 h | 0 | 80 | other: no effect observed |
cornea score | animal #2 Number 13 | 24, 48 and 72 h | 1 | 80 | fully reversible within: 3 days |
cornea score | animal #3 Number 15 - washed eye | 24, 48 and 72 h | 0 | 80 | other: no effects observed |
cornea score | animal #4 Number 12 | 24, 48 and 72 h | 0,333 | 80 | fully reversible within: 2 days |
cornea score | animal #5 Number 14 - washed eye | 24, 48 and 72 h | 0,333 | 80 | fully reversible within: 2 days |
cornea score | animal #6 Number 16 - washed eye | 24, 48 and 72 h | 0,333 | 80 | fully reversible within: 2 days |
conjunctivae score Redness | animal #1 Number 11 | 24, 48 and 72 h | 2 | 20 | fully reversible within: 3 days |
conjunctivae score Redness | animal #2 Number 13 | 24, 48 and 72 h | 2 | 20 | fully reversible within: 3 days |
conjunctivae score Redness | animal #3 Number 15 - washed eye | 24, 48 and 72 h | 1 | 20 | fully reversible within: 3 days |
conjunctivae score Redness | animal #4 Number 12 | 24, 48 and 72 h | 1,33 | 20 | fully reversible within: 3 days |
conjunctivae score Redness | animal #5 Number 14 - washed eye | 24, 48 and 72 h | 1,66 | 20 | fully reversible within: 3 days |
conjunctivae score Redness | animal #6 Number 16 - washed eye | 24, 48 and 72 h | 1 | 20 | fully reversible within: 3 days |
conjunctivae score Chemosis | animal #1 Number 11 | 24, 48 and 72 h | 0,33 | 20 | fully reversible within: 2 days |
conjunctivae score Chemosis | animal #2 Number 13 | 24, 48 and 72 h | 0,66 | 20 | fully reversible within: 3 days |
conjunctivae score Chemosis | animal #3 Number 15 - washed eye | 24, 48 and 72 h | 0 | 20 | other: no effects observed |
conjunctivae score Chemosis | animal #4 Number 12 | 24, 48 and 72 h | 0,33 | 20 | fully reversible within: 2 days |
conjunctivae score Chemosis | animal #5 Number 14 - washed eye | 24, 48 and 72 h | 0,33 | 20 | fully reversible within: 2 days |
conjunctivae score Chemosis | animal #6 Number 16 - washed eye | 24, 48 and 72 h | 0 | 20 | other: no effects observed |
iris score | animal #1 Number 11 | 24, 48 and 72 h | 0 | 10 | other: no effect observed |
iris score | animal #2 Number 13 | 24, 48 and 72 h | 0,33 | 10 | fully reversible within: 2 days |
iris score | animal #3 Number 15 - washed eye | 24, 48 and 72 h | 0 | 10 | other: no effect observed |
iris score | animal #4 Number 12 | 24, 48 and 72 h | 0,33 | 10 | fully reversible within: 2 days |
iris score | animal #5 Number 14 - washed eye | 24, 48 and 72 h | 0,33 | 10 | fully reversible within: 2 days |
iris score | animal #6 Number 16 - washed eye | 24, 48 and 72 h | 0 | 10 | other: no effect observed |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Some studies are available both for skin and eye irritation based on the patch-test method described in Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)
The results show:
- no eye irritation for observation at 1, 24, 48 and 72 h.
- no skin irritation for observation at 1, 24, 48 and 72 h.
Acid Orange 7 doesn't show any irritating effects and as a consequence it could be stated that is not corrosive or irritant.
Justification for selection of skin irritation / corrosion endpoint:
The study was performed on a tested substance with a higher content of active ingredient.
Justification for selection of eye irritation endpoint:
The study was the most complete and assessed the effect on cornea, iris and conjunctiva.
Justification for classification or non-classification
No classification for skin irritation/corrosion is warranted under CLP Regulation (EC n. 1272/2008)
No classification for eye irritation/corrosion is warranted under CLP Regulation (EC n. 1272/2008)
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