Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 695-938-6 | CAS number: 678966-16-0
- 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
Skin irritation:
The study was performed in accordance with OECD Guideline 404. The test material produced a mean erythema score of 2.83 and oedema score of 0.83. It was concluded that application of the test substance was moderately irritating by acute dermal irritation.
Eye irritation:
The study was performed in accordance with OECD Guideline 405. It was concluded that application of the test substance was severe irritating (rating 6) by acute eye irritation (unwashed test), was moderately irritating (rating 5) 4 s after instillation of the substance and was moderately irritating (rating 5) 30 s after instillation of the substance.
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:
- From 2015-01-12 to 2015-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- non GLP, but in compliance with China National Metrology Accreditation
- Specific details on test material used for the study:
- Batch No.: 141104
Purity: 95.4% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zhejiang Center of Laboratory Animals , Hangzhou, Zhejiang
- Weight at study initiation: About 2 kg
- Housing: Housed individually in suspended, wire bottom, stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12-hour light / dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
CONTROL
A single intact exposure site was selected as the test site, while the contralateral intact site served as a control site. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 4 Males or female (nulliparous and non - pregnant)
- Details on study design:
- TEST SITE
- Area of exposure: At least 3 x 3 cm
- Type of wrap if used: Orthopedic stockinette
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin cleaned of residual test item using room temperature tap water
- Time after start of exposure: Four hours
OBSERVATION TIME POINTS
All animals should be examined for signs of erythema and oedema, and the responses scored at 24, 48 and 72 hours after patch removal. If there is damage to skin which cannot be recorded at 72 hours, observations rnay be needed until day 14 to determine the reversibility of the effects. If reversibility has been observed/ seen before 14 days, the experiment should be terminated at that time.
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test material produced a mean erythema score of 2.83 and oedema score of 0.83. It was concluded that application of the test substance was moderately irritating by acute dermal irritation.
- Executive summary:
The evaluation of acute dermal irritation/corrosion potential in white rabbits was conducted on the test substance according to OECD Guideline 404: Acute Dermal Irritationl Corrosion Test (Ministry of Environmental Protection of the People's Republic of China, 2004).
There was one intact test site per animal. Each test animal was treated with 0.5g test substance and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made up to 14 days after removal of the dressings, or until reversibility was seen.
Both erythema and edema were observed in the skin of New Zealand white rabbits after the patch removal, the test was end on the 11th day. Therefore, the maximum primary irritation index of the test substance was calculated to be 3.75.
Based on the results, it was concluded that the application of the test substance was moderately irritating by acute dermal irritation.
- 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
- Justification for type of information:
- An in vivo skin irritation study is available, which was performed in order to satisfy the China new chemical notification scheme.
Referenceopen allclose all
Inidividual scores for dermal irritation:
Number | Symptom | 24 h | 48 h | 72 h | 14 d |
1 | Erythema Edema |
3 1 |
3 1 |
3 1 |
- - |
2 | Erythema Edema |
3 1 |
4 1 |
4 1 |
- - |
3 | Erythema Edema |
3 1 |
4 1 |
4 1 |
- - |
4 | Erythema Edema |
1 1 |
1 0 |
1 0 |
- - |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- From 2015-01-12 to 2015-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- non GLP, but in compliance with China National Metrology Accreditation
- Specific details on test material used for the study:
- Batch No.: 141104
Purity: 95.4% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Zhejiang Center of Laboratory Animals, Hangzhou, Zhejiang
- Weight at study initiation: about 2 kg
- Housing: housed individually in suspended, wire bottom, stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7/8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30% to 70%
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12-hour light / dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 4 s, 30 s
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 11 Males or female (nulIiparous and non - pregnant)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Six additional New Zealand white rabbits were used for washed test. 4 s after instillation, three eyes of the rabbits were washed for 30 s, using 0.9% saline water. 30 s after instillation, another three eyes of rabbits were washed for 30 s, using 0.9% saline water.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- It was concluded that application of the test substance was severe irritating (rating 6) by acute eye irritation (unwashed test), was moderately irritating (rating 5) 4 s after instillation of the substance and was moderately irritating (rating 5) 30 s after instillation of the substance.
- Executive summary:
The evaluation of acute eye irritation / corrosion potential in white rabbits was conducted on the test substance according to the Guidelines for the Testing of Chemicals: Test No. 405: Acute Eye Irritation / Corrosion Test (Ministry of Environmental Protection of the People's Republic of China, 2004).
0.1 g of the test substance was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were then gently washed with 0.9% saline water, for 24 hours after instillation of the test substance. Parameters measured during the observation period included the conjunctivae, cornea and iris. Six additional New Zealand white rabbits were used for washed test. 4 s after instillation, three eyes of the rabbits were washed for 30 s, using 0.9% saline water. 30 s after instillation, another three eyes of rabbits were washed for 30 s, using 0.9% saline water.
Observation results of eye reaction after the application were shown as diffuse, crimson colour, individual vessels not easily discernible, obvious swelling, with partial eversion of lids, increased secretions accompanied by wet eyelid and eyelashes, corneal damage, iris hyperemia. The highest average of total score until 4 d after instillation was 45.0. Duration of irritation reaction was the average of total score on 7 d >20. All the signs were restored on the 21th day. Observation was finished on the 21th day.
Observation results of eye reaction (washed test, 4 s after instillation) were shown as diffuse, swelling, with lids about half closed, increased secretions, accompanied by wet eyelid and eyelashes. The highest average of total score until 4 d after instillation was 29.33. Duration of irritation reaction was the average of total score on the 7th day ≤ 20, more than half of animals ≤ 10.
Observation results of eye reaction (washed test, 30 s after instillation) were shown as diffuse beefy red, swelling, with lids about half closed, increased secretions, accompanied by eyelids, eyelashes and a large area around the eyes moist. The highest average of total score until 4d after instillation was 40.67. Duration of irritation reaction was the average of total score on the 7th day ≤ 10, more than half of animals ≤ 10.
It was concluded that application of the test substance was severe irritating (rating 6) by acute eye irritation (unwashed test), was moderately irritating (rating 5) 4 s after instillation of the substance and was moderately irritating (rating 5) 30 s after instillation of the substance.
- 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
- Justification for type of information:
- An in vivo eye irritation study is available, which was performed in order to satisfy the China new chemical notification scheme.
Referenceopen allclose all
Inidividual scores for ocular irritation (unwashed test):
Animal |
Symptom |
Observation |
1 h |
24 h |
48 h |
72 h |
21 d |
1 |
Cornea |
Degree |
- |
1 |
1 |
1 |
0 |
Iris |
|
1 |
1 |
1 |
1 |
0 |
|
Conjunctivae |
Redness |
2 |
3 |
3 |
3 |
0 |
|
Conjunctivae |
Swelling |
2 |
4 |
4 |
4 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The evaluation of acute dermal irritation/corrosion potential in white rabbits was conducted on the test substance according to OECD Guideline 404: Acute Dermal Irritationl Corrosion Test (Ministry of Environmental Protection of the People's Republic of China, 2004).
There was one intact test site per animal. Each test animal was treated with 0.5g test substance and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made up to 14 days after removal of the dressings, or until reversibility was seen.
Both erythema and edema were observed in the skin of New Zealand white rabbits after the patch removal, the test was end on the 11th day. Therefore, the maximum primary irritation index of the test substance was calculated to be 3.75.
Based on the results, it was concluded that the application of the test substance was moderately irritating by acute dermal irritation.
Eye irritation:
The evaluation of acute eye irritation / corrosion potential in white rabbits was conducted on the test substance according to the Guidelines for the Testing of Chemicals: Test No. 405: Acute Eye Irritation / Corrosion Test (Ministry of Environmental Protection of the People's Republic of China, 2004).
0.1 g of the test substance was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were then gently washed with 0.9% saline water, for 24 hours after instillation of the test substance. Parameters measured during the observation period included the conjunctivae, cornea and iris.Six additional New Zealand white rabbits were used for washed test. 4 s after instillation, three eyes of the rabbits were washed for 30 s, using 0.9% saline water. 30 s after instillation, another three eyes of rabbits were washed for 30 s, using 0.9% saline water.
Observation results of eye reaction after the application were shown as diffuse, crimson colour, individual vessels not easily discernible, obvious swelling, with partial eversion of lids, increased secretions accompanied by wet eyelid and eyelashes, corneal damage, iris hyperemia. The highest average of total score until 4 d after instillation was 45.0. Duration of irritation reaction was the average of total score on 7 d >20. All the signs were restored on the 21th day. Observation was finished on the 21th day.
Observation results of eye reaction (washed test, 4 s after instillation) were shown as diffuse, swelling, with lids about half closed, increased secretions, accompanied by wet eyelid and eyelashes. The highest average of total score until 4 d after instillation was 29.33. Duration of irritation reaction was the average of total score on the 7th day ≤ 20, more than half of animals ≤ 10.
Observation results of eye reaction (washed test, 30 s after instillation) were shown as diffuse beefy red, swelling, with lids about half closed, increased secretions, accompanied by eyelids, eyelashes and a large area around the eyes moist. The highest average of total score until 4d after instillation was 40.67. Duration of irritation reaction was the average of total score on the 7th day ≤ 10, more than half of animals ≤ 10.
It was concluded that application of the test substance was severe irritating (rating 6) by acute eye irritation (unwashed test), was moderately irritating (rating 5) 4 s after instillation of the substance and was moderately irritating (rating 5) 30 s after instillation of the substance.
Justification for classification or non-classification
Skin irritation/corrosion:
In accordance with Regulation (EC) No. 1272/2008 Table 3.2.2, substance can be classified as Category 2: Irritant when 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.
As mean scores at 24, 48 & 72 hours for erythema were 3.25, 3, 3 for 4 test animals, respectively; mean scores at 24, 48 & 72 hours for edema were 1, 0.75, 0.75 for 4 test animals, respectively; and irritating was seen to be fully reversible within 14 days, therefore this substance should be classified as Category 2 for the Skin irritation/corrosion endpoint.
Serious eye damage/eye irritation:
In accordance with Regulation (EC) No. 1272/2008 Table 3.3.2, substance that have the potential to induce reversible eye irritation are classified in Category 2 when mean scores at 24, 48 & 72 hours for corneal opacity were ≥ 1 and/or for iris were ≥ 1 and/or for conjunctival redness were ≥ 2 and/or for conjunctival oedema (chemosis) were ≥ 2 in at least 2 of 3 tested animals.
As mean scores of cornea opacity, iris, conjunctivae redness and conjunctival swelling were 1, 1, 3, 4 at 24, 48 and 72 hours after administrations and irritating was seen to be fully reversible within 21 days, therefore this substance should be classified Category 2 for the Serious eye damage/eye irritation endpoint.
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.
