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Diss Factsheets
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EC number: 700-924-0 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-04-09 to 2013-04-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (Skin Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- RN 2949 Reg
- IUPAC Name:
- RN 2949 Reg
- Reference substance name:
- Acid Red RN 2949
- IUPAC Name:
- Acid Red RN 2949
- Details on test material:
- Name: Acid Red RN 2949
Batch No.: RN 2949 Reg
Chemical Name: 1-naphthalenesulfonic acid, 3,3´-[(phenylmethylene)-bis[(2-methoxy-4,1-phenylene)-2,1-diazenediyl]]bis[4-hydroxy-, disodium salt
Formula C41H30N4Na2O10S2
Physical State: powder
Colour: dark red
pH: 6-8
Molecular Weight: 848.82 g/mol
Content / Purity: 100 % (composition see AZ. No. 12-2302/4928 vl., dated 2012-08-28
Storage Conditions: room temperature
Expiry Date: 05.03.2015
Constituent 1
Constituent 2
Test system
- Amount / concentration applied:
- 10 mg + 15 µL aqua dest.
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 +/- 1 h
- Details on study design:
- The test was performed on EpiSkin, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item (10 mg + 15 µL A. dest. to ensure good contact and even distribution), the negative control (10µL PBS) and the positive control (10µL 5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.
Results and discussion
In vivo
- Other effects:
- The test item showed no direct MTT reducing capability. The mixture of 10 mg of the test item per 90 µl aqua dest. showed colouring detectable by unaided eye-assessment. Since the colour turned red (which is not detected by measurement at 550 nm) and could not be extracted from the tissues, no quantitative correction of results was necessary.
Any other information on results incl. tables
Name |
Negative Control |
Positive Control |
Test Item |
|||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
absolute OD550 |
1.056 |
0.935 |
1.002 |
0.134 |
0.092 |
0.104 |
1.017 |
1.280 |
0.991 |
|
1.002 |
0.872 |
0.963 |
0.130 |
0.091 |
0.099 |
0.993 |
1.237 |
0.985 |
||
OD550(blank-corrected) |
1.014 |
0.894 |
0.960 |
0.092 |
0.050 |
0.062 |
0.975 |
1.238 |
0.949 |
|
0.960 |
0.830 |
0.922 |
0.088 |
0.049 |
0.057 |
0.952 |
1.195 |
0.943 |
||
mean OD550of the duplicates |
0.987 |
0.862 |
0.941 |
0.090 |
0.050 |
0.060 |
0.964 |
1.217 |
0.946 |
|
total mean OD550of 3 replicate tissues (blank-corrected) |
0.930* |
0.066 |
1.042 |
|||||||
SD OD550 |
0.064 |
0.019 |
0.136 |
|||||||
relative tissue viabilities [%] |
106.2 |
92.7 |
101.2 |
9.7 |
5.4 |
6.4 |
103.6 |
130.8 |
101.7 |
|
mean relative tissue viability [%] |
100.0 |
7.1** |
112.1 |
|||||||
SD tissue viability [%]*** |
6.8 |
2.3 |
16.3 |
|||||||
CV [% viability] |
6.8 |
31.5 |
14.5 |
* Corrected mean OD550 of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is < = 40%.
*** The standard deviation (SD) obtained from the three concurrently tested tissues is < 18%.
Applicant's summary and conclusion
- Interpretation of results:
- other: non irritant
- Remarks:
- Criteria used for interpretation of results: other: OECD 439
- Conclusions:
- The test item is classified as "non-irritant" (No Category).
- Executive summary:
In the in vitro skin irritation test using the EpiSkin human epidermis model 10 mg test item + 15 µL A. dest. were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.
The mean relative tissue viability (% negative control) was > 50%.
The test item is therrefore classified as "non-irritant" (EU CLP and UN GHS: No Category).
This study is classified as acceptable:
OD550 of the blank is < 0.1.
Mean OD550 of the three negative control tissues is >= 0.6 and <= 1.5.
Mean relative tissue viability of the three positive contol tissues is <= 40%.
Standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%.
This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation.
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