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EC number: 306-832-3 | CAS number: 97416-84-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 14 to April 17, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted Guideline and in according to the GLP Principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Internal Procedure SOP 118 008 40
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- EC Number:
- 306-832-3
- EC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Cas Number:
- 97416-84-7
- Molecular formula:
- C23H24Br8O2
- IUPAC Name:
- 1,3-dibromo-2-(2,3-dibromo-2-methylpropoxy)-5-{2-[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)phenyl]propan-2-yl}benzene
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test system
- Amount / concentration applied:
- 23.5 mg (Tissue 1)
23.1 mg (Tissue 2)
23.1 mg (Tissue 3) - Duration of treatment / exposure:
- 60 ± 5 min. after the first application and the incubation period the inserts were rinsed
- Details on study design:
- TEST SYSTEM
Specification: Commercially available EpiDermTMKit.
The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Origin: EpiDermTMKit from MatTek In Vitro Life Science Laboratories (Batch n. 21654).
CHEMICALS AND MEDIA
MTT Reagent
Contains 1 mg/ml 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide as concentrate in DBPS buffer (5 mg/ml, stored at –20 ± 5 °C).
Origin: prepared by LAUS GmbH
A MTT stock solution of 5 mg/mL in DPBS buffer was prepared and stored in aliquots of 2 ml at – 20 ± 5 °C. 2 ml of the stock solution were thawed and diluted with 8 mL of me-dium (resulting in 1 mg/ml).
DPBS-Buffer
Dulbecco’s Phosphate Buffered Saline (DPBS buffer without CaCl2 and MgCl2).
Origin: MatTek In Vitro Life Science Laboratories and prepared by LAUS GmbH
Composition of the subset from MatTek In Vitro Life Science Laboratories (batch n.: 020315MHA):
Used as negative control and for rinsing the test item from the tissues
KCl 0.2 g
KH2PO4 0.2 g
NaCl 8.0 g
Na2HPO4 * 7H2O 2.16 g
H2O ad 1 l
Composition of the subset from LAUS GmbH (batch: 20150226):
Solvent for MTT concentrate and for rinsing the outside of the inserts at the end of the in-cubation time with MTT.
KCl 0.2 g
KH2PO4 0.2 g
NaCl 8.0 g
Na2HPO4 * 7H2O 2.16 g
H2O ad 1 l
Positive Control
Sodium dodecyl sulphate (SDS): solution in deionised H2O containing 5 % SDS
Origin: MatTek In Vitro Life Science Laboratories (batch no.: 020615TMH).
MEM Medium with Phenol Red for Pre-Test
Serum-free MEM (Minimum Essential Medium).
Origin: Gibco/Invitrogen (Batch no.: 1613667)
Assay Medium
Serum-free DMEM (Dulbecco’s Modified Eagle’s Medium).
Origin: MatTek In Vitro Life Science Laboratories (batch no.: 040915TMA)
Isopropanol:
Purity 99.9 %,
Batch no.: 310060213050,
used as extracting solvent for formazan.
TEST VESSELS
Vessels materials: glass or sterilisable plastic.
Sterilised before use by rinsing with ethanol 70% or autoclaving.
Vessels used: 6, 24 and 96 well-plates
INSTRUMENT AND DEVICES used during the test:
Autoclave, 3870 ELV-B
Stop-watch
96-well-plate photometer, Anthos Reader
Precision scales, Mettler Toledo PB 5001-SO2 Labostyle
Analytical scales, Mettler Toledo XS 205 DU
Incubation chamber Binder
Table water bath, neoLabAdjustable pipettes with sterile tips
Clean bench, category 2 (Axo Safe, MARS 12000)Orbital shaker, GFL 3005
Bulb-headed pipettes, sterile
Single-use pipettes
Nylon mesh circles 8 mm diameter (200 µm pore (EPI-MESH))
Pipetting device, Accujet
Refrigerator and freezer
Weighing funnels
Microscope
Standard Laboratory material (glassware)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Absorbance
- Value:
- 2.089
- Remarks on result:
- other:
- Remarks:
- Basis: mean of the three tissues (%). Remarks: relative standard deviation of the three tissues = 2.1 %. (migrated information)
- Irritation / corrosion parameter:
- other: other: % Formazan production
- Value:
- 112.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Remarks: percentage values of formazan production calculated in comparison to the negative control. (migrated information)
Any other information on results incl. tables
The photometric absorbance of the negative controls is considered as 100 %. For each replicate of test item and positive control, formazan production is calculated as % photometric absorbance compared with the mean of the negative controls:
% Formazan production = [OD mean of negative controls/ODreplicate test item resp. positive control]*100%
where OD is the Optical Density
Absorbance values blank isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.041 |
0.038 |
0.038 |
0.038 |
0.037 |
0.037 |
0.038 |
0.037 |
0.038 |
Absorbance Values of Negative control, Positive Control and Test item
Designation |
Measurement |
Negative Control |
AP 1300 S |
Positive Control |
Tissue 1 |
1 |
2.023 |
2.148 |
0.097 |
2 |
1.919 |
2.206 |
0.089 |
|
Tissue 2 |
1 |
1.701 |
2.131 |
0.088 |
2 |
1.726 |
2.069 |
0.085 |
|
Tissue 3 |
1 |
2.002 |
2.129 |
0.089 |
2 |
2.025 |
2.081 |
0.087 |
Mean absorbance Values
Designation |
Negative Control |
AP 1300 S |
Positive Control |
Mean – blank (tissue 1) |
1.933 |
2.139 |
0.055 |
Mean – blank (tissue 2) |
1.676 |
2.062 |
0.049 |
Mean – blank (tissue 3) |
1.976 |
2.067 |
0.050 |
Mean of the three tissues |
1.862 |
2.089 |
0.051 |
Relative standard deviation |
8.7 % |
2.1 % |
6.3 % |
% Formazan Production
Designation |
AP 1300 S |
Positive Control |
% Formazan production (tissue 1) |
114.9 % |
3.0 % |
% Formazan production (tissue 2) |
110.7 % |
2.6 % |
% Formazan production (tissue 3) |
111.0 % |
2.7 % |
% Formazan production (mean) |
112.2 % |
2.8 % |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information According to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- 112.2 % of the relative absorbance
- Executive summary:
Method
The substance has been tested in order to evaluate the skin irritation potential according to the EU method B.46 and OECD 439.
During the test three tissues of the human skin model EpiDermTM has been treated with on average 25 mg of test item for 60 minutes. Both positive and negative control have been prepared.
Observations
After the treatment with the test item, the relative absorbance values were increased, compared to the negative control, to 112.2 %.
The Optical Density (OD) of the negative control (1.9) was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control induced a decrease in the relative absorbance as compared to the negative control to 2.8 % (required: ≤ 20 %). For these reasons the validity criteria of the test system has been fulfilled.
Conclusion
The 112.2 % value of the relative absorbance is above the threshold for irritation potential set out in the OECD guideline, therefore the substance is considered as not irritant in the Human Skin Model Test.
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