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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 606-191-2 | CAS number: 18979-61-8
- 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
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 761/2009, Method B.46; 'In-vitro skin irritation : Reconstructed human epidermis model test' adopted 23 July 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation : Reconstructed Human Epidermis (RhE) Test Method, Version 7.6, 9 September 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM international validation study on in vitro tests for acute skin irritation : Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6) : 559-601)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol for IN VITRO EpiDerm TM Skin Irritation Test (EPI-200-SIT), Rev. 3/23/2009, matTek Corporation, Ashland, MA 01721, USA
- Deviations:
- no
Test material
Constituent 1
Test animals
- Species:
- other: In-vitro assessment using EpiDerm TM tissue
- Strain:
- other: In-vitro assessment using EpiDerm TM tissue
Test system
- Type of coverage:
- other: In-vitro assessment using EpiDerm TM tissue
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Percentage value of formazan production in comparison to negative control
- Value:
- 24.9
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 1. Time point: 60 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Percentage value of formazan production in comparison to negative control
- Value:
- 24.7
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 2. Time point: 60 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Percentage value of formazan production in comparison to negative control
- Value:
- 25.2
- Remarks on result:
- other:
- Remarks:
- Basis: other: Tissue 3. Time point: 60 minutes. (migrated information)
Any other information on results incl. tables
Findings and Results
Measured Values
As blank, the optical density of isopropanol was measured in eight wells of the 96 well plate. The measure values and their mean are given in the following table :
Replicate | Absorption |
1 | 0.041 |
2 | 0.051 |
3 | 0.040 |
4 | 0.038 |
5 | 0.040 |
6 | 0.039 |
7 | 0.042 |
8 | 0.036 |
Mean | 0.041 |
Designation | Measurement | Negative Control | 4 -N-Butylresorcinol | Positive Control |
Tissue 1 | 1 | 2.293 | 0.545 | 0.223 |
Tissue 1 | 2 | 2.273 | 0.538 | 0.225 |
Tissue 2 | 1 | 2.149 | 0.537 | 0.230 |
Tissue 2 | 2 | 1.986 | 0.536 | 0.235 |
Tissue 3 | 1 | 1.825 | 0.548 | 0.231 |
Tissue 3 | 2 | 1.776 | 0.548 | 0.235 |
Designation | Negative Control | 4 -N-Butylresorcinol | Positive Control |
Mean - blank (tissue 1) | 2.242 | 0.501 | 0.183 |
Mean - blank (tissue 2) | 2.027 | 0.496 | 0.192 |
Mean - blank (tissue 3) | 1.760 | 0.507 | 0.192 |
Mean of the three tissues | 2.010 | 0.501 | 0.189 |
Relative standard deviation of the three tissues | 12.0% | 1.1% | 2.7% |
Designation | 4 -N-butyl resorcinol | Positive Control |
% Formazan production (tissue 1) | 24.9% | 9.1% |
% Formazan production (tissue 2) | 24.7% | 9.6% |
% Formazan production (tissue 3) | 25.2% | 9.6% |
% Formazan production mean | 24.9% | 9.4% |
Criterion | Demanded | Found |
OD of negative control | between 1.0 and 2.5 | 2.010 |
% Formazan production of positive control | <=20% of negative control | 9.4% |
Variation within replicates (RSD) | <18% | 12.0% (negative control)2.7% (positive control)1.1% (test item) |
The value of the positive control was within the range of historical data.
The value for the negative control was not within the range of historical data of the test facility. This is considered as uncritical for the following reason : the deviation was only 0.6% above the respective range of the historical data. Variation of biological systems within this order of magnitude is not unusual ; furthermore, for the preparation of different batches of cell cultures, different cell donors may have been used. Therefore the experiment is considered valid.
The photometric absorption of the negative controls is considered as 100%. For the mean of the three replicates of the test item and positive control, formazan production is calculated as % photometric absorption compared with the negative control :
% Formazan production = [OD test item / OD negative control] x 100
Skin irritation potential of the test item is assessed as given in the following :
% Formazan production Assessment
<50% of negative control Irritant
>50% of negative control Non-irritant
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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