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EC number: 279-087-4 | CAS number: 79135-87-8
- 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
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:
- August from the 26th to the 30th, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on 12 May, 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoering, AG.
- Age at start of treatment: ca. 12 weeks.
- Body weight at start of treatment: 2.3 - 3 kg.
- Diet: pelleted standard Kliba 23/341/1 rabbit maintenance diet, ad libitum.
- Water: tap water, ad libitum.
- Accomodation: individually in stainless steel cage.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light/dark. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: polyethylene glycol (PEG 400) + saline (70 : 30 parts)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1 g of a 50 % dilution of the test substance in polyethylene glycol (PEG 400) + saline (70 : 30 parts) was used.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 1 females
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before the treatment, the back and flanks of each rabbit were closely clipped with electric clippers, exposing an area of skin of ca 10 x 10 cm. the test material was applied under a patch of surgical gauze approximately 3.0 x 3.0 cm.
- Type of wrap if used: the patch was covered with impermeable material and fastened to the body with adhesive tape.
OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1 hour, 24, 48, 72 hours, following removal of bandages and gauze patch.
SCORING SYSTEM
Draize 1959; Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- 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 test, the substance was found to cause no irritation when applied to intact rabbit skin.
In the area of application, no discolouration of the skin was observed in the rabbits which could be related to compound effects.
No corrosion effect had occurred on the skin at each measuring interval. - Interpretation of results:
- other: not classified, according to CLP Regulation (EC) No1272/2008
- Conclusions:
- Not skin irritating
- Executive summary:
The skin irritation potential of the test material was investigated by occlusive topical application to three New Zeland White rabbits. 1 g of a 50 % dilution of the test substance in polyethylene glycol (PEG 400) + saline (70 : 30 parts) was used.
The treated skin site was observed 1 hour, 24, 48, 72 hours, following removal of bandages and gauze patch and the skin reactions were scored in accordance with Draize system (1959) and Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
Under the conditions of the test, the substance was found to cause no irritation when applied to intact rabbit skin.
In the area of application, no discolouration of the skin was observed in the rabbits which could be related to compound effects.
No corrosion effect had occurred on the skin at each measuring interval.
Conclusion
The mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
Reference
Animal | Reaction | 1 hr | 24 htrs | 48 hrs | 72 hrs |
371 M | Erythema | 0 | 0 | 0 | 0 |
372 M | Erythema | 0 | 0 | 0 | 0 |
373 F | Erythema | 0 | 0 | 0 | 0 |
371 M | Oedema | 0 | 0 | 0 | 0 |
372 M | Oedema | 0 | 0 | 0 | 0 |
373 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:
- August from the 26th to the 30th, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 12 May, 1981
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoering, AG.
- Age at start of treatment: ca. 12 weeks.
- Body weight at start of treatment: 2.3 - 3 kg.
- Diet: pelleted standard Kliba 23/341/1 rabbit maintenance diet, ad libitum.
- Water: tap water, ad libitum.
- Accomodation: individually in stainless steel cage.
- Acclimation period: 4 days.
- Health check: before testing, both eyes of each animal were examined and any animal with eye defect was rejected.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light/dark. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g/rabbit
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
-
SCORING SYSTEM
The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment.
Draize 1959; Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
Corneal opacity
No ulceration or opacity 0
Scattered or diffuse areas, details of iris clearly vsible 1
Easily discernible translucent area, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4
Area of cornea affected
No ulceration or opacity 0
One quarter or less but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia 1
No reaction to light, haemorrhage, gross destruction 2
Conjuctival redness
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
Conjunctival oedema (chemosis)
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
Discarge
No discharge 0
Any amount different from normal 1
Discharge with moistening of the lids and hairs 2
Discharge with moistening of the lids and hairs, in a considerable area 3
In addition the colouration of sclera/cornea was recorded in connection with the colour of the test compound. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hrs in 2 out of 3 animals; no information about the 3rd animal because the test was stopped at 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa.
No discolouration of the cornea and conjunctivae which could be related to compound effects was observed.
The primary irritaiton index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals. - Interpretation of results:
- other: not classified, according to CLP Regulation (EC) No1272/2008
- Conclusions:
- Not eye irritating
- Executive summary:
The eye irritation potential of te test item was assessed in accordance with method and procedures outlined into the OECD guideline 405. 0.1 g of test substance were placed in the rabbit eyes, which were not rinsed. The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment, according to the Draize system (1959) and in accordance with the Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States criteria.
Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa. No discolouration of the cornea and conjunctivae which could be related to compound effects was observed. The primary irritaiton index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals.
Conclusion
The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals. No corrosion effect was observed at each of the measuring intervals. In one case the recovery of the redness cannot be judged because the test was stopped before; nevertheless, based on the severity of the effect observed and the decrease over the test period, the lacking of this information can be considered as not critical and not impacting the test outcomes conclusion.
Thus, the substance can be considered as non irritating to eye, according to the CLP Regulation (EC) No 1272/2008.
Reference
Individual reactions
Animal No | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean 24/48/72 hrs |
374 M | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
375 F | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
376 F | Cornea opacity | 0 | 0 | 0 | 0 | 0.00 |
374 M | Iris | 0 | 0 | 0 | 0 | 0.00 |
375 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
376 F | Iris | 0 | 0 | 0 | 0 | 0.00 |
374 M | Conjunctival redness | 2 | 1 | 1 | 1 | 1.00 |
375 F | Conjunctival redness | 1 | 0 | 0 | 0 | 0.00 |
376 F | Conjunctival redness | 2 | 1 | 1 | 0 | 0.67 |
374 M | Conjunctival chemosis | 1 | 1 | 0 | 0 | 0.33 |
375 F | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.00 |
376 F | Conjunctival chemosis | 1 | 0 | 0 | 0 | 0.00 |
374 M | Conjunctival discharge | 2 | 2 | 0 | 0 | - |
375 F | Conjunctival discharge | 1 | 0 | 0 | 0 | |
376 F | Conjunctival discharge | 1 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
The skin irritation potential of the test material was investigated by occlusive topical application to three New Zeland White rabbits.1 g of a 50 % dilution of the test substance in polyethylene glycol (PEG 400) + saline (70 : 30 parts) was used. The treated skin site was observed 1 hour, 24, 48, 72 hours, following removal of bandages and gauze patch and the skin reactions were scored in accordance with Draize system (1959) and Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.
Under the conditions of the test, the substance was found to cause no irritation when applied to intact rabbit skin. In the area of application, no discolouration of the skin was observed in the rabbits which could be related to compound effects. No corrosion effect had occurred on the skin at each measuring interval.
In addition, the water-diluted substance was tested for skin irritation potential to rabbits. The irritation was measured by a patch test technique in 6 rabbits (males and females) and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41. In the intact skin neither erythema nor edema were observed. In the abraded skin after 24 hours, all six animals showed very slight or well defined erythema but no edema. After four days, all these findings had disappeared. In two aninals, the treated abraded area was slightly scaly.
Since the diluted substance was tested item, the results cannot be used for classification purposes; they have been included into the dossier exclusively for completeness sake.
EYE IRRITATION
The eye irritation potential of the test item was assessed in accordance with method and procedures outlined into the OECD guideline 405. 0.1 g of test substance were placed in the rabbit eyes, which were not rinsed. The eye were examined and the grade of ocular reaction recorded at 1, 24, 48 and 72 hours after treatment, according to the Draize system (1959) and in accordance with the Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States criteria.
Under the conditions of the test, the substance was found to cause no irritation when applied to rabbit eye mucosa. No discolouration of the cornea and conjunctivae which could be related to compound effects was observed. The primary irritation index was found to be 3.3
No corrosion effect was observed at each of the measuring intervals. In one case the recovery of the redness cannot be judged because the test was stopped before; nevertheless, based on the severity of the effect observed and the decrease over the test period, the lacking of this information can be considered as not critical and not impacting the test outcomes conclusion.
In addition, the water-diluted substance was tested for eye irritation potential to rabbits. 0.1 ml of the test material was placed into the conjunctival sac of the right eyes of the animals. Three males and three females were used; in addition, in three males treated eyes were washed after instillation; the left eye served as control. Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).
No ocular findings at all were observed neither in the unrinsed nor the rinsed eye.
Since the diluted substance was tested item, the results cannot be used for classification purposes; they have been included into the dossier exclusively for completeness sake.
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.
The mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
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 grading 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 animals.
In conclusion, the substance does not meet the criteria to be classified for the skin/eye irritation, according to the CLP Regulation (EC) No 1272/2008.
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