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EC number: 212-791-1 | CAS number: 870-08-6
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Key study:- Warren (2012a) OECD 431, EU Method B.40, Not corrosive (in vitro, Reconstructed Human Epidermis (RHE) model)
Key study:- Warren (2012b), OECD 439, EU Method B.46, Not irritating (in vitro, Reconstructed Human Epidermis (RHE) model)
EYES
Key study:- Sanders (2012) OECD 405, EU Method B.5, Non-irritant (Rabbit, male)
Supporting study:- Warren (2012c) SkinEthic Reconstituted Human Corneal model, Non-iritant (in vitro, SkinEthic Reconstituted Human Corneal model)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2012 to 27 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to the standardised guidelines OECD 439 and EU Method B.46 and in line GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Details on test animals or test system and environmental conditions:
- EPISKIN Model Kit
Supplier: SkinEthic Laboratories, Nice, France - Amount / concentration applied:
- 10 mg of the solid test item was applied topically.
- Duration of treatment / exposure:
- 15 minutes
- Number of animals:
- Not applicable
- Irritation / corrosion parameter:
- other: other: OD540
- Value:
- 0.515
- Remarks on result:
- other:
- Remarks:
- Basis: mean triplicate tissues. Time point: 15 minutes. Max. score: 0.567. Remarks: ± SD (0.066). (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean viability (%)
- Value:
- 66.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean triplicate tissues. Time point: 15 minutes. Max. score: 100.0. Remarks: value in percent (%). ± SD (8.5 %). (migrated information)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a 'non-irritant' to the skin.
- Executive summary:
The purpose of the test was to evaluate the skin irritation potential of the test material using the EPISKIN in vitro Reconstructed Human Epidermis (RHE) Model. This method was designed to be compatible with the OECD Guideline for the Testing of Chemicals No. 439 “In Vitro Skin Irritation” (adopted 22 July 2010) and Method B.46 of Commission Regulation (EC) No. 440/2008.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labelled 96 well plate. The optical density (OD) was measured at 540 nm (OD540).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test material treated tissues was 66.7 % after the 15 minute exposure period. The quality control criteria required for acceptance of results in the test were satisfied. Under the conditions of the test, the test material was concluded to be a non-irritant to the skin.
Reference
Direct MTT Reduction
The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.
Main Test - Results
The relative mean viability of the test material treated tissues was 66.7 % after a 15 minute exposure period
Table 1: Results
Item |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 Relative individual tissue viability (%) |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relaive mean viability (%) |
|
Negative control item |
0.748 |
0.771 |
0.025 |
97.0 |
100* |
3.2 |
|
0.769 |
99.7 |
||||||
0.797 |
103.4 |
||||||
Positive control item |
0.104 |
0.079 |
0.022 |
13.5 |
10.2 |
2.9 |
|
0.07 |
9.1 |
||||||
0.062 |
8.0 |
||||||
Test material |
0.567 |
0.515 |
0.066 |
73.5 |
66.7 |
8.5 |
|
0.441 |
57.2 |
||||||
0.536 |
69.5 |
SD = standard deviation
* = the mean viability of the negative control tissues is set at 100 %
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 10.2 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 2.9 %. The positive control criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.771 and the standard deviation value of the percentage viability was 3.2 %. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 8.5 %. The test material acceptance criterion was therefore satisfied.
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:
- 5 November 2012 - 21 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to standardised guidelines OECD 405 and EU Method B.5 and in line with GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.23 - 2.88 kg
- Housing: individually in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 5 November 2012 - 21 November 2012 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to approximately 78 mg) - Duration of treatment / exposure:
- - Dose administration: 0.1 mL of the test material was placed into the conjunctival sac of the right eye of one rabbit, by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were then held together for about 1 second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses in the first treated animal, a second animal was treated.
- Observation period (in vivo):
- Animals were observed up to 7 days post administration
- Number of animals or in vitro replicates:
- One male initially, followed by a further male once the irritation potential was fully assessed in the first animal.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was not performed
SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1977).
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye at the 24 hour observation. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye at 24 hours while minimal conjunctival irritation was noted in the other treated eye at 24 hours. Minimal conjunctival irritation persisted in both treated eyes to the 48 and 72 hour observations. Both treated eyes appeared normal at the 7 day observation.
- Other effects:
- Both animals showed expected gain in bodyweight during the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As there was no corneal involvement in any of the two treated eyes, and mean values for the 24 to 72-Hour time points were 0.2, 1.3 and 1.2 for iritis, conjunctival redness and conjunctival chemosis, respectively, the test material is not irritating in rabbit eyes. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008
- Executive summary:
The eye irritation of the test material was determined in accordance with standardised guidelines OECD 405 and EU Method B.5. During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and were assessed for up to 7 days to determine the grade of ocular reaction. No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye at the 24 hour observation. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye at 24 hours while minimal conjunctival irritation was noted in the other treated eye at 24 hours. Minimal conjunctival irritation persisted in both treated eyes to the 48 and 72 hour observations. All signs of irritation had completely resolved within 7 days of application.
Under the conditions of the study, the test material is not irritating in rabbit eyes. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.
Reference
Table 2: Ocular Irritation Results
Animal |
1 |
2 |
||||||||
Time after treatment |
1 h |
24 h |
48 h |
72 h |
7 d |
1 h |
24 h |
48 h |
72 h |
7 d |
Cornea |
|
|||||||||
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
|||||||||
Iris |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|||||||||
Redness |
2 |
2 |
2 |
1 |
0 |
2 |
1 |
1 |
1 |
0 |
Chemosis |
2 |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
1 |
0 |
Discharge |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
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
In the key study, Warren (2012a), the corrosivity potential of the test material was determined using the validated EPISKIN in vitro Reconstructed Human Epidermis (RHE) model. The study was performed in compliance with GLP and in accordance with the standardised guidelines OECD 431 and EU Method B.40 and as such, the study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality described in Klimisch (1997).
Under the conditions of the study the relative mean viability of the test item treated tissues were: 240 minutes exposure: 106.3 % ; 60 minutes exposure: 108.9 % ; 3 minutes exposure: 132.1 %. The test item was subsequently considered to be Non-Corrosive to the skin.
Following on from the negative in vitro skin corrosion study, the skin irritation potential of the test material was determined in the key study Warren (2012b) using the validated EPISKIN in vitro Reconstructed Human Epidermis (RHE) model. The study was performed in compliance with GLP and in accordance with the standardised guidelines OECD 439 and EU Method B.46 and as such, the study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality described in Klimisch (1997).
Under the conditions of the study, the relative mean viability of the test material treated tissues was 66.7 % after the 15 minute exposure period. The quality control criteria required for acceptance of results in the test were satisfied. The test material was subsequently concluded to be a non-irritant to the skin.
Eye
In the supporting study, reported by Warren (2012c) the eye irritation potential of the test material was determined in a non-standardised guideline study performed in line with good scientific practices and in line with GLP. The reliability of the study was assigned a reliability score of 2 in accordance with the principles for assessing data quality in accordance with Klimisch (1997) due to the pre-validation status of the protocol. The irritation potential was assessed using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Lyon, France) after a treatment period of 10 minutes.
Solution A served as the negative control and 2 % w/v Sodium Dodecyl Sulphate served as the positive control. Under the conditions of the study the relative mean viability of the test material treated tissues after a 10 minute exposure was 102.3 %. It was, therefore, considered unnecessary to proceed with tissue histopathology. According to the protocol followed the test material was considered to be a non-irritant.
Following on from the negative in vitro eye irritation study, the eye irritation potential of the test material was determined in the key study, reported by Sanders (2012). The study was performed in line with standardised guidelines (OECD 405 and EU Method B.5) and in accordance with GLP, the study was therefore assigned in accordance with the principles for assessing data quality as described in Klimisch (1997). During the study, 0.1 mL of test material was placed into one eye of each of two rabbits and were assessed for up to 7 days to determine the grade of ocular reaction. No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye at the 24 hour observation. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in one treated eye at 24 hours while minimal conjunctival irritation was noted in the other treated eye at 24 hours. Minimal conjunctival irritation persisted in both treated eyes to the 48 and 72 hour observations. All signs of irritation had completely resolved within 7 days of application. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.
Justification for selection of skin irritation / corrosion endpoint:
In vitro study to determine the skin irritation potential of the test material. Supporting information is available on skin corrosivity, however, skin irritation potential cannot be assessed on the basis of this information which is why the aforementioned study on skin irritation potential has been selected as the key study.
Justification for selection of eye irritation endpoint:
The study reported by Sanders (2010) was selected as the key study since it is an vivo study to determine eye iritation potential of test material. Supporting information is available in the form of an in-vitro study.
Justification for classification or non-classification
Skin
In accordance with with criteria for classification and labelling as defined in Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD), the test material does not require classification for skin irritation and corrosion.
Eye
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008 and Directive 67/548/EEC (DSD), the test material does not require classification for eye irritation.
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