Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 262-996-5 | CAS number: 61788-67-8
- 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
Not irritant for skin, slightly irritant for eyes
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:
- April 13-19, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to well-documented and supported procedures for which no guideline (OECD, etc.) exists
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material for 15 minutes and incubation for 42 hours by means of the colourmetric MTT reduction assay.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - EPISKIN Model Kit
- Source: SkinEthic Laboratories, Nice, France
- Date received: 13 April 2010
- All other template details: Not applicable
ENVIRONMENTAL CONDITIONS: Not applicable
IN-LIFE DATES: Not applicable - Type of coverage:
- other: uniform topical coverage
- Preparation of test site:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 µl
VEHICLE: Not applicable - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- Not applicable
- Number of animals:
- Three tissues per test material, positive control, and negative control for a total of 9 skin models analyzed
- Details on study design:
- TEST SITE
- Area of exposure: entire EPISKIN tissue
- % coverage: 100
- Type of wrap if used: Not applicable
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with dulbeccos phosphate buffered saline (PBS) with calcium and magnesium
- Time after start of exposure: at the end of the 15 minute exposure period
SCORING SYSTEM: optical density at 540 nm was measured and divided by the negative control optical density and multiplied by 100 to obtain a percentage for the relative mean viability.
- If the relative mean tissue viability was less or equal to 50%, the compound is predicted to be an irritant.
- If the relative mean tissue viability was greater than 50%, the compound is predicted not to be an irritant. - Irritation / corrosion parameter:
- other: other: relative mean viability based on OD540 measurements
- Value:
- 102.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Max. score: 108.9. Reversibility: other: not applicable. Remarks: scores are percentages of mean negative control OD540 values . (migrated information)
- Irritant / corrosive response data:
- See Table 1 for raw data values
- Other effects:
- Test material was shown to directly reduce MTT. However, rinsing was effective at removing the test material on or in the tissue following each exposure period and no degree of interference was noted.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a non-irritant to the skin.
- Executive summary:
Summary from data report:
Introduction: The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTMreconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourmetric MTT reduction assay. Cell viability is measured by enzymatic reduction of yellow MTT tetrazolium salt (3 -[4,5 -dimethylthiazol-2 -yl]-2,5 -diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-1alpha in the culture medium retained following the 42 hour post-exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.
Methods: Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubation for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to the negative control tissues).
Results: The relative mean viability of the test material treated tissues was 102.2% after a 15 minute exposure.
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion: The test material was considered to be Non-Irritant.
Reference
Table 1. Individual and Mean OD540 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material.
Material |
OD540of tissues |
Mean OD540of triplicate tissues (±SD) |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control material |
0.638 |
0.629 |
101.4 |
100 |
1.2 |
0.623 |
99.0 |
||||
0.627 |
99.7 |
||||
Positive control material |
0.194 |
0.175 |
30.8 |
27.9 |
2.6 |
0.164 |
26.1 |
||||
0.168 |
26.7 |
||||
Test material |
0.623 |
0.643 |
99.0 |
102.2 |
5.8 |
0.621 |
98.7 |
||||
0.685 |
108.9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- May 17-27 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 405, EU B.5)
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40 or2.42 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum to 2030 Teklad global rabbit diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12 dark-light
IN-LIFE DATES: not reported - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
VEHICLE: Not applicable - Duration of treatment / exposure:
- Test material was applied to eye, and the eyelids were held together for about 1 second and then released. Eyes were not rinsed after exposure.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Not applicable
SCORING SYSTEM: initial pain reaction from 6-point scale, Draize scale for scoring ocular irritation was used during the observation period. After scores were assigned, a modified version of Kay and Calandra (1962) was used to classify the ocular irritancy potential.
TOOL USED TO ASSESS SCORE: ophthalmoscope - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- other: Both test animals had scores of 12 at 1 hour, which had diminished to 6 at 24 hours. Both had a score of 0 at 48 and 72 hours.
- Irritant / corrosive response data:
- See Table 1.
- Other effects:
- Body weight changes after 3 days: +0.05 kg
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: modified Kay and Calandra 1962
- Conclusions:
- The test substance was determined to be a minimal irritant (Class 3 on a 1 - 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. .
- Executive summary:
Study report summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD guidelines for the testing of chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
- Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Result. A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. Both treated eyes appeared normal at the 48 -Hour observation.
Conclusion. The test material produced a maximum group mean score of 12.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
Table 1. Individual Scores and Individual Total Scores for Ocular Irritation
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Some results for the whole family of fat liquors are reported. The whole family can be also compared to the family of Linear Alcan Sulphate/sulphonated and the fatty soap in general. In all those molcules, eye irritation is generally dependent to the molecular weight of the substance. being fatty acids derivatives the smaller molecular weight in the whole family, eye irritation can be assumedSkin and eye irritation data are available for the sodium salt of sulfated castor oil. These 1984 reasonably well documented studies conclude the test substance is not irritating to the skin but is irritating to the eye. Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate the substances are non-irritating and non-corrosive to the skin, and are slightly irritating to the eye based on OECD guideline studies.
Justification for selection of skin irritation / corrosion endpoint:
vegetal oil derivatives is the structural analogous more symilar to fatty acid vegetable and the first methabolite
Justification for selection of eye irritation endpoint:
vegetal oil derivatives is the structural analogous more symilar to fatty acid vegetable and the first methabolite
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on existing studies the substance is classified as slightly irritant for the eyes, corresponding to a classification in category B and H 319 following Regulation 1272/2008 (CLP)
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.