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Diss Factsheets
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EC number: 946-448-9 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol
- EC Number:
- 939-479-4
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol
- Test material form:
- other: viscous liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) (in 1,2-propylene glycol)
- Name of product (as cited on Certificate of Analysis): MARLON AMI 80
- Substance type: technical product
- Physical state: yellow-brown viscous liquid
- Analytical purity: 78% w/w benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol
- Lot No.: 126
- Expiration date of the lot: 01 June 2013
- Storage condition of test material: room temperature in the dark
- Other: data not verified by the laboratory; identity details were supplied by the Sponsor
Constituent 1
Test animals
- Species:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Three-dimensional reconstructed human epidermis- EPISKIN model kit purchased from SkinEthic Laboratories (Nice, France).
Test system
- Type of coverage:
- other: not applicable
- Controls:
- other: not applicable
- Amount / concentration applied:
- not applicable
- Duration of treatment / exposure:
- 3, 60 and 240 min
- Details on study design:
- Pre-test: Test MTT reduction by the test material: 50 ul test material + 2.2 ml 0.3 mg/ml MTT solution incubated for 3 h. The blue colour indicates reduced MTT.
MAIN TEST
DAY 1-Application of test item
Exposure: 3, 60 and 240 min
Amount applied: 50 ul
Negative control: 50 ul of 0.9% w/v sodium chloride
Positive control: 50 ul glacial acetic acid
Washing: PBS with Ca++ and Mg++
MTT solution was applied: 2.2 ml of 0.3 mg/ml per well, incubation followed for 3 h ± 5 min
Biopsy of the epidermis was performed. The tissue was then transfered in micro tubes with 850 ul acidified isopropanol.
DAY 2-Absorbance/Optical Density
at 540 nm with Anthos 2001 microplate reader
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 minutes
- Value:
- 66.5
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 83.8
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minnutes
- Value:
- 87.9
Any other information on results incl. tables
Table 1: Mean OD540 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
Exposure Period |
Mean OD540 of duplicate tissues |
Relative mean viability (%) |
Negative Control Item |
240 min |
0.173 |
100 |
Positive Control Item |
240 min |
0.033 |
19.1 |
Test Item |
240 min |
0.115 |
66.5 |
60 min |
0.145 |
83.8 |
|
3 min |
0.152 |
87.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this in vitro test MARLON AMI 80, and hence benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1), are not corosive to the skin.
- Executive summary:
The skin corrosion potential of MARLON AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 1,2-propylene glycol) was examined in this in vitro test with the EPISKINTMreconstructed human epidermis model. Exposure to the substance lasted 3, 60, and 240 minutes.The principle of the assay was based on the measurement of cytotoxicity in the human epidermal cultures following topical exposure to the test item, with the MTT reduction assay.
The relative mean viability of the test item treated tissues was 66.5, 83.8 and 87.9%, after the exposure periods of 240 60, and 3 minutes, respectively. Therefore, MARLON AMI 80 is not corrosive to the skin. Based on this result, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) shall not be considered as skin corrosive.
The study is considered acceptable based on the quality criteria. The test was performed according to the OECD Guidelines for the Testing of Chemicals No. 431 “In VitroSkin Corrosion” (adopted April 2004).
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