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EC number: 432-170-0 | CAS number: -
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline 431 and EC method B40
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan cytotest cell research GmbH
- Details on test animals or test system and environmental conditions:
- Human skin model test.
- Amount / concentration applied:
- 25 mg test material per tissue.
- Duration of treatment / exposure:
- 3 minutes and 1 hour.
- Irritation parameter:
- other: Relative absorbance
- Basis:
- mean
- Time point:
- other: 3
- Score:
- > 50
- Max. score:
- 80
- Reversibility:
- no data
- Remarks on result:
- other: In vitro study
- Irritant / corrosive response data:
- Not corrosive to skin according UN GHS / EU CLP Cat.1 / DSD
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Not corrosive to skin according UN GHS / EU CLP Cat.1 / DSD
- Executive summary:
This in vitro study was performed to assess the corrosive potential of D-100 by means of the Human Skin Model Test. Independent duplicate tissues of the human skin model EST-1000™ were exposed to the test item, the negative control or the positive control for 3 minutes and 1 hour, respectively. About 25 mg of the solid test material were applied to the tissues and wetted with 50 μL deionised water. A volume of 50 μL of either the negative control (deionised water) or the positive control (8.0 N KOH) was applied to each tissue. After exposure to the negative control the absorbance values exceeded the required acceptability criterion of mean OD570 ≥ 0.8 for both treatment intervals thereby confirming the acceptable quality of the tissues. Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period and for the 1 hour exposure period thus confirming the validity of the test system. After exposure to the test item D-100 the relative absorbance values decreased to 72.7% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to
80.7%. Nevertheless, both values are well above the threshold of 50% for the 3 minutes exposure and above 15% for the 1 hour exposure. Therefore, the test item was considered to be not corrosive. In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item D-100 was non corrosive to skin according to UN GHS / EU CLP Cat.1 / DSD (67/548/EEC).
Reference
Dose group | Exposure interval | Absorbance 570 nm Tissue 1* | Absorbance 570 nm Tissue 2* | Mean absorbance of 2 tissues | Rel. Absorbance [% of negative control]** |
Negative control | 3 min | 1.345 | 1.377 | 1.361 | 100 |
Positive control | 3 min | 0.073 | 0.090 | 0.081 | 6.0 |
D-100 | 3 min | 1.074 | 0.904 | 0.989 | 72.7 |
Negative control | 1 hour | 1.152 | 1.229 | 1.190 | 100.0 |
Positive control | 1 hour | 0.021 | 0.011 | 0.016 | 1.3 |
D-100 | 1 hour | 1.005 | 0.916 | 0.960 | 80.7 |
* Mean of three replicate wells after blank correction
**relative absorbance: = 100 x (absorbance of test item)/ (absorbance of negative control)
The optical evaluation of the MTT-reducing capacity of the test item after one hour incubation with MTT-reagent did not show evidence of a blue colour and thereby was not considered to be a MTT reducer.
The test item D-100 is considered to be non-corrosive to skin:
- since the viability after 3 minutes exposure is greater than 50 % and
- the viability after 1 hour exposure is greater than 15%.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline 437 and EC test method B47
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest cell research GmbH
- Details on test animals or tissues and environmental conditions:
- isolated bovine cornea according to OECD guideline 437
- Amount / concentration applied:
- 0.75 mL
- Duration of treatment / exposure:
- 240 minutes
- Irritation parameter:
- other: In vitro score
- Basis:
- mean
- Time point:
- other: 240
- Score:
- < 55.1
- Max. score:
- 0.19
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Not corrosive / not severe irritant to the eye
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Not corrosive / not severe irritant to the eye
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of D- 100 by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item D-100, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and Lglutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects corresponding to a classification as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the test item D-100 did not cause any increase of the corneal opacity or permeability. The calculated mean in vitro irritation score was 0.00. According to OECD 437 the test item is classified as not corrosive / not severe irritant to the eye. In conclusion, according to the current study and under the experimental conditions reported, the test item D-100 is not corrosive / not severe irritant to the eye (CLP/EPA/GHS (Cat 1)).
Reference
Table of results.
Results after 240 minutes incubation time.
*corrected values
**negative values are only calculated values that do not reflect reality
Test group | opacity value = difference (t240 -t0 ) of opacity | Mean | permeability at 490 nm (OD490) | Mean | in vitro score | mean in vitro irritation score | proposed in vitro irritation scale |
Negative control | 231 | 2.00 | 0.0630.0560.055 | 0.058 | 2.953.841.83 | 2.87 | Non corrosive / non severe irritant |
Positive control | 192.00*172.00*185.00* | 0.046*0.036*0.017* | 192.69172.54185.26 | 183.50 | Corrosive / severe irritant | ||
D-100 | -1.00*-2.00*-2.00* | 0.079*0.002*-0.002* | 0.19-1.97-2.03 | 0.00 (-1.27**) | Non corrosive / non severe irritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Key study reveiled the product is not irritant and not corrosive to skin.
Justification for selection of eye irritation endpoint:
Key study reveiled the product is not irritant and not corrosive to the eye.
Justification for classification or non-classification
Key test report reveiles that the test substance is not irritant and not corrosive to the skin and not irritant / corrosive to the eye.
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.
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