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EC number: 268-974-1 | CAS number: 68155-62-4
- 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 skin irritating
Not eye irritating
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:
- February from 21st to 27th, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.3 - 2.5 kg
- Acclimation period: 3 days. - Type of coverage:
- not specified
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 1 female
- Details on study design:
- OBSERVATION TIME POINTS
1, 24, 48 and 72 hours.
SCORING SYSTEM
ERYTHEMA AND ESCHAR FORMATION
No enythema 0
Very slight enythema (barely perceptible) 1
Well defined enythema 2
Moderate to severe enythema 3
Sevene erythema (beet redness) to slight eschar formation (injuries in depth) 4
OEDEMA FORMATION
No edema 0
Veny sIight edema (barely perceptible) 1
Slight edema (edges of area weIl defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Sevene edema (raised more than 1 mm and extending beyond area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Under the conditions of the experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application, a hardly perceptible yeIlow discolouration of the skin was observed, which could be related to effects of the test article.
No corrosion effect has occurred on the skin at each measuring interval. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) 1272/2008
- Conclusions:
- Not skin irritating
- Executive summary:
The primary skin irritation potential of the substance was investigated according to OECD test guideline no. 404. The test item was moinstened with tap water, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours.
Under the conditions of the experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application, a hardly perceptible yeIlow discolouration of the skin was observed, which could be related to effects of the test article.
No corrosion effect has occurred on the skin at each measuring interval.
Conclusion
Mean values from gradings at 24, 48 and 72 hours were lower than 2.3 in all animals for both erythema/eschar and oedema reactions. Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Animal N. | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs |
29 M | Erythema | 0 | 0 | 0 | 0 |
30 F | Erythema | 0 | 0 | 0 | 0 |
29 M | Oedema | 0 | 0 | 0 | 0 |
30 F | Oedema | 0 | 0 | 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:
- February from 21st to 27th, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.4 - 2.5 kg
- Acclimation period: 3 days. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 1 female
- Details on study design:
- TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL and Varta Cliptrix diagnostic-lamp.
SCORING SYSTEM
CORNEAL IRRITATION
Opacity: degree of density (densest area used for assessment)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal Iuster), details of iris clear visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
IRIDIC IRRITATION
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis, lid and/on nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4 - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2/2
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.
No corrosion effect has occurred at each measuring intervals. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) 1272/2008
- Conclusions:
- Not eye irritating
- Executive summary:
The primary eye irritation potential of the substance was investigated according to OECD test guideline no. 405. The test item was applied undiluted, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours.
Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.
No corrosion effect has occurred at each measuring intervals.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals.
Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
Reference
Animal N | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs |
15 M | Cornea opacity | 0 | 0 | 0 | 0 |
16 F | Cornea opacity | 0 | 0 | 1 | 0 |
15 M | Iris | 0 | 0 | 0 | 0 |
16 F | Iris | 0 | 0 | 0 | 0 |
15 M | Conjuntivae redness | 0 | 1 | 1 | 0 |
16 F | Conjuntivae redness | 1 | 1 | 1 | 0 |
15 M | Conjuntivae chemosis | 2 | 0 | 0 | 0 |
16 F | Conjuntivae chemosis | 1 | 1 | 0 | 0 |
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN IRRITATION
The primary skin irritation potential of the substance was investigated according to OECD test guideline no. 404. The test item was moinstened with tap water, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours. Under the conditions of the experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application, a hardly perceptible yeIlow discolouration of the skin was observed, which could be related to effects of the test article. No corrosion effect has occurred on the skin at each measuring interval.
In addition, the primary skin irritation potential of the substance was investigated in an old test run with 6 female rabbits. 0.5 g of test material were applied to intact and scarified skin, over an area of 25 cm2. The scoring of skin reactions was performed at 24 and 72 hours. Under the conditions of the experiment, the test item was found to not cause any irritation to none of the tested animals, both for intact and scarified skin.
Since there are no details about the testing method and procedures, as well as there are no details about the composition of the tested lot, a reliability cannot be assigned.
EYE IRRITATION
The primary eye irritation potential of the substance was investigated according to OECD test guideline no. 405. The test item was applied undiluted, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours. Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article. No corrosion effect has occurred at each measuring intervals.
In addition, the primary eye irritation potential of the substance was also investigated in an old test, in which two experiments were run, each one using 6 rabbits. After administration, one eye was rinsed, while the other not; the scoring of eye reactions was performed at 24, 48, 72 hours and at the day 7th.
Under the conditions of the experiment, the test item was found to not cause irritation to none of the rinsed eyes of the tested animals. The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis and lower than 2 for conjunctival oedema, in both the rinsed and not rinsed eyes of at least 11 out of 12 tested animals. The mean value from gradings of conjunctival redness resulted to be lower than 2 in rinsed eyes of all the animals; however, in not rinsed eyes the value resulted within 2 and 2.67 in 11 out of 12 animals and the effects were not fully recovered withing 7 days in 3 out of 12 animals.
Since there are no details about the testing method and procedures, as well as there are no details about the composition of the tested lot, a reliability cannot be assigned: the impact of possible impurity(ies) cannot be excluded; the amount of the substance administrated, as well as the form (e.g. redness due to powder irritating potential) are not known, thus possibile effects due to the substance form cannot be excluded; in addition, observation period was 7 days, instead of the 21 days indicated in the current version of the OECD standarized method, thus not sufficient for an adequate evaluation of the recovery ability.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
Mean values from gradings at 24, 48 and 72 hours were lower than 2.3 in all animals for both erythema/eschar and oedema reactions. Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
According to the CLP Regulation (EC) No 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, which is not fully reversible within 21 days of application.
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals. Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.
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