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EC number: 815-096-7 | CAS number: 1421927-53-8
- 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
Skin irritation:
Three tissues of the human skin model EpiDermTMwere treated with EDA-DOPO for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size.
DPBS-buffer was used as negative control, 5% SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. Relative absorbance was reduced to 2.9% (required: < 20%).
Variation within the tissue replicates was acceptable (required: ≤ 18%).
After the treatment with the test item, the relative absorbance values were reduced to 93.6 %. This value is above the threshold for skin irritation potential (50%).
Therefore, EDA-DOPO is considered as non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
Eye irritation:
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test itemEDA-DOPOwas brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for4 hours at32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
HBSS-solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 1.92.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 132.32.
Under the conditions of the study, the test itemEDA-DOPOshowed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) was 0.18.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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:
- 2016-09-23 - 2016-10-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:EpiDermTM-Kit, procured by MatTek
- Tissue batch number(s):23362
- Delivery date:11. Oct. 2016
- Date of initiation of testing:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:37 ± 1°C
- Temperature of post-treatment incubation (if applicable):37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:
1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:1 mg/mL
- Incubation time:3 hours
- Spectrophotometer:plate spectrophotometer
- Wavelength:570 nm - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- negative control: 30 µL DPBS buffer
positive control: 30 µL 5% SDS-solution
test item: 25.6 mg, 24.9 mg,25.7 mg - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 23 hours and 27 minutes at 37 ± 1°C
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item
- Value:
- 93.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- 2.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- EDA-DOPO is considered as non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
Three tissues of the human skin model EpiDermTMwere treated with EDA-DOPO for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size.
DPBS-buffer was used as negative control, 5% SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. Relative absorbance was reduced to 2.9% (required: < 20%).
Variation within the tissue replicates was acceptable (required: ≤ 18%).
After the treatment with the test item, the relative absorbance values were reduced to 93.6 %. This value is above the threshold for skin irritation potential (50%).
Therefore, EDA-DOPO is considered as non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
Reference
% Formazan Production
Designation |
EDA-DOPO |
Positive Control |
% Formazan production (tissue 1) |
99.2% |
2.9% |
% Formazan production (tissue 2) |
87.8% |
2.9% |
% Formazan production (tissue 3) |
94.0% |
2.8% |
% Formazan production (mean) |
93.6% |
2.9% |
± SD of mean Formazan production (%) |
5.7% |
0.1% |
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:
- 2016-09-23 - 2016-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source:slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
- Number of animals:3
- Characteristics of donor animals (e.g. age, sex, weight):between 12 and 60 months
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):The eyes were transported to the test facility in Hank’s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.
- indication of any existing defects or lesions in ocular tissue samples:None of the corneas showed tissue damage; therefore, all corneas were used. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µL negative control solution and positive control solution
432.4 mg, 431.3 mg, 431.7 mg test item - Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test item
- Value:
- 0.18
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- negative control
- Value:
- 1.92
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- positive control
- Value:
- 132.32
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test item EDA-DOPO showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) was 0.18.
- Executive summary:
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item EDA-DOPO was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for4 hours at32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
HBSS-solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 1.92.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 132.32.
Under the conditions of the study, the test item EDA-DOPO showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) was 0.18.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
Reference
IVIS Values
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.29 |
1.92 |
29.23% |
2.11 |
|||
2.35 |
|||
Test Item |
1.22 |
0.18 |
596.48% |
-0.91 |
|||
0.22 |
|||
Positive Control 20% imidazole solution |
146.85 |
132.32 |
10.77% |
131.76 |
|||
118.36 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation, the substance has not to be classified as skin or eye irritant.
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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