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EC number: 266-658-8 | CAS number: 67352-37-8
- 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
Non irritant to intact rabbit skin.
Non irritant to rabbit eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 18 to November 25,1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The complete read across justification is detailed in section 13. Source study has reliability 2.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG 4414 Fuellinsdorf / Switzerland
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard kliba 23/341/1, rabbit maintenance diet defined for acceptable contaminant level, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- ca 10 × 10 cm
- Vehicle:
- other: PEG 400 + physiological saline solution (70:30)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 1 g of a 50 % diluition of test material in polyethylene glycol (PEG400) + saline (70:30) was applied under a patch of surgical gauze ca. 3 × 3 cm. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours after treatment.
- Number of animals:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- TEST SITE
- Clipped area: 10 x 10 cm
- Type of wrap if used: surgical gauze 3 cm x 3 cm. When the patch was in place it was covered with impermeable material and fastened to the body with adhesive tape
SCORING SYSTEM: Draize J.H 1959
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Under the conditions of the experiment the test material was found to cause no irritation when applied to intact rabbit skin.
- Executive summary:
Method
The substance was tested for skin irritation according to the OECD guideline 404. The dorsal area of 3 rabbits was clipped and test substance was applied under occlusive patch for 4 hours. Reactions were scored 1 hour, 24, 48 and 72 hours after removal according to the Draize score.
Results
Under test conditions, the substance was found to cause no irritation when applied to intact rabbit skin. In the area of application a marked to slight orange discoloration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage. No corrosion effect had occurred on the skin.
Reference
Test substance showed no irritation, when applied to intact rabbit skin. No destruction or irreversible alterations of the treated skin were observed.
In the area of application a marked to slight orange discolouration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage.
No acute toxicological signs were observed in the animals durin g the test period.
All rabbits were killed at the end of the observation period. Due to the results obtained, no macroscopical organ examination was indicated.
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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From November 18 to 25, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The complete read across justification is detailed in section 13. Source study has reliability 2.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG 4414 Fuellinsdorf / Switzerland
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 23/341/1, rabbit maintenance diet defined for acceptaeble contaminant level, ad libitum
- Water: tap water, ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g to the left eye of each animal - Duration of treatment / exposure:
- single application into conjunctival sac
- Observation period (in vivo):
- 1, 24, 48, 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- SCORING SYSTEM: Draize J.H. 1959
Cornea opacity and degree of density (most dense area scored)
0 no opacity
1 scattered or diffuse area, details of iris clearly visible
2 easily discernible translucent areas, details of iris slightly obscured
3 opalescent areas, no details of iris visible, siz eof pupils barely discernible
4 opaque, iris invisible
Iris
0 normal
1 folds above normal, congestion, swelling, circumcornea injection (nay or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrage, gross destruction (any or all of these)
Conjunctivae redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red
Conjuctivae chemosis
0 no swelling
1 any swelling above normal (includes nictitating membrane)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids about half to completely closed - Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no eye reaction observed
- Remarks on result:
- other: not rinsed
- Other effects:
- No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period, which could be related to compound effects.
No acute toxicological signs were observed in the rabbits during the test period. - Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Under test conditions, test substance was found to cause no irritation when applied to the rabbit eye mucosa.
- Executive summary:
Method
The substance was evaluated for eye irritation/corrosion according to the OECD guideline 405. Test substance was applied to the left eye of each animal and the eye was not rinsed. The right eye served as control.Reactions were scored 1 hour, 24, 48 and 72 hours after application.
Results
Under test conditions, the substance was found to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctiva which could be related to compound effect was observed. No corrosion effect was observed at each of the measuring intervals.
Reference
Upon sacrifice, no macroscopical organ examination was indicated, due to the results obtained.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No information is available on the substance itself, i.e. Solvent Orange 062 acid. However, a study on a read across substance, i.e. Solvent Orange 062 sodium salt containing some amounts of its acid form, was available and used for the assessment. A detailed description of the read across process was attached in section 13.
Skin irritation
The substance was tested for skin irritation according to OECD guideline 404. Under test conditions, no signs of skin irritation were noted. In the area of application a marked to slight orange discolouration of the skin was observed in all rabbits within 1 to 72 hours after removal the bandage. No acute toxicological signs were seen in animals during the test period.
Eye irritation
The substance was tested for eye irritation/corrosion according to OECD guideline 405. During the test, the eye was not rinsed, however, no signs of irritation were noted. No discolouration of the cornea and conjunctivae, related to compound effects, was observed. No acute toxicological signs were seen in animals during the test period.
Justification for classification or non-classification
Skin Irritation
According to the CLP Regulation (EC 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
A substance has to be classified as category 1 (corrosive) if it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration.
A substance has to be classified as category 2 (irritant) if shows:
(1) mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Under the test condition, no signs of irritation were observed, thus no classification applied. Based on the read across approach, Solvent Orange 062 was considered as non irritant to skin.
Eye Irritation
According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application .
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
A substance has to be classified as category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
A substance has to be classified as category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:
at least in 2 of 3 tested animals, a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
The substance did not show any effect on eye, thus no classification applied. Based on a read across approach, Solvent Orange 062 was considered as non irritant to eye.
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