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Diss Factsheets
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EC number: 944-536-1 | 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
Endpoint summary
Administrative data
Description of key information
In vitro skin and eye irritation studies have been conducted on unchanged and undiluted test material and are, therefore, considered key in preference to an in vivo skin irritation study in which the test material contained 50% active component in white vaseline. The in vitro studies are also in accordance with the updated ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a, Version 5.0, December 2016.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS
- Version / remarks:
- 3rd revision
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200 SIT Kit
- Tissue batch number(s): 23314
- Production date: Not reported
- Shipping date: Not reported
- Delivery date: 16 February 2016
- Date of initiation of testing: Pre-incubation phase started 16 February 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 ºC
- Temperature of post-treatment incubation (if applicable): 37 ± 1 ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 300 μL, one washing step
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Not applicable, microplate reader
- Wavelength: 570 ± 1 nm
- Filter: Not reported
- Filter bandwidth: 570 ± 1 nm
- Linear OD range of spectrophotometer: Not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Positive control; 4.77 %
- Barrier function: Not reported
- Morphology: Not reported
- Contamination: None reported
- Reproducibility: Relative standard deviation for mean viability; 14.79 % postive control. Relative standard deviation for mean absorption; 16.6 % postive control, 8.55 % negative control.
NUMBER OF REPLICATE TISSUES: 3 per control and test item treatment
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues Not applicable
- Procedure used to prepare the killed tissues (if applicable): Not applicable
- N. of replicates : Not applicable
- Method of calculation used: Not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 43.5 hours exposure is less than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL
- Concentration (if solution): Undiluted test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): Not reported
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): 5 % SLS in deioinsied water; concentration not reported - Duration of treatment / exposure:
- 43.5 hours
- Duration of post-treatment incubation (if applicable):
- 67.5 hours
- Number of replicates:
- 3 per test item, negative control or postive control
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 1
- Value:
- 0.601
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 2
- Value:
- 0.592
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 3
- Value:
- 0.585
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Mean
- Value:
- 0.593
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 1
- Value:
- 38.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 2
- Value:
- 37.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 3
- Value:
- 37.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Mean
- Value:
- 37.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Standard deviation: 1.4 %
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: Did not show blue colour after 1 hour incubation
- Colour interference with MTT: No colour change
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, within the required range of OD ≥ 0.8 and ≤ 2.8
- Acceptance criteria met for positive control: Yes, induced a decrease in absorbance of 5.1 % compared to the negative control - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- and EU CLP criteria
- Conclusions:
- The test item is a category 2 irritant to skin according to UN GHS regulations based on a human skin model test conducted following OECD 439, EU B.46 and UN GHS guidelines and performed according to GLP.
- Executive summary:
The test item was assessed for skin irritation in a human skin model test conducted following OECD 439, EU B.46 and UN GHS guidelines in undiluted form alongside a postive and negative control. The results of the test indicate that the test item is a Category 2 irritant to skin according to the UN GHS regulations.
The study is a GLP compliant guideline experiment study available as an unpublished study report. The study has no restrictions and is fully adequate for assessment.
Reference
Results of treatment with test item and the controls
Dose Group | Exposure Interval | Tissue No. | Absorbance 570 nm (Well 1) | Absorbance 570 nm (Well 2) | Absorbance 570 nm (Well 3) | Mean Absorbance of 3 Wells* | Mean Absorbance of three wells blank corrected | Mean Absorbance of three tissues after blank correction | Rel. Absorbance (%) 1, 2 + 3** | Relative Standard Deviation (%) | Mean. Rel. Absorbance (% of negative control)*** |
Blank | 0.037 | 0.038 | 0.038 | 0.038 | 0.000 | ||||||
Negative Control | 60 mins | 1 | 1.540 | 1.548 | 1.508 | 1.532 | 1.495 | 1.563 | 95.6 | 4.1 | 100.0 |
2 | 1.644 | 1.591 | 1.593 | 1.609 | 1.572 | 100.6 | |||||
3 | 1.717 | 1.631 | 1.630 | 1.659 | 1.622 | 103.8 | |||||
Positive Control | 60 mins | 1 | 0.117 | 0.120 | 0.118 | 0.118 | 0.081 | 0.080 | 5.2 | 4.4 | 5.1 |
2 | 0.118 | 0.107 | 0.116 | 0.113 | 0.076 | 4.8 | |||||
3 | 0.104 | 0.132 | 0.124 | 0.120 | 0.083 | 5.3 | |||||
Test item | 60 mins | 1 | 0.646 | 0.628 | 0.643 | 0.639 | 0.601 |
0.593 |
38.5 |
1.4 |
37.9 |
2 |
0.617 |
0.645 |
0.627 |
0.629 |
0.592 |
37.9 |
|||||
3 |
0.613 |
0.625 |
0.630 |
0.623 |
0.585 |
37.4 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue (rounded values): 100*(absorbancetissue)/ (mean absorbancenegative control)
***relative absorbance per treatment group (rounded values): 100*(mean absorbancetest item/positive control)/ (mean absorbancenegative control)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 February 2016 to 18 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; for use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model; 29 June 2015
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Test item sourced from test sponsor, batch number: 10300010
- Expiration date of the lot/batch: January 2017
- Purity test date: Sum of Main Isomer: 96.30 Area %, Sum Isomers: 99.73 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None - Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: In a prevalidation study performed by Avon Products Inc. and MatTek Corporation, the in vitro eye test using the human cornea model EpiOcular™ and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have indicated this method as a sufficiently promising predictor for eye irritancy potential. The EpiOcular ™ Eye Irritation Test (EIT) was validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe between 2008 and 2013.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: EpiOcular™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells which progressively flatten out as the apical surface of the tissue is approached, analogous to the normal in vivo corneal epithelium. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 μL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- 3 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used: MatTek Corporation Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; for use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model (June 2015) followed.
- RhCE tissue construct used, including batch number: EpiOcular™ kits and MTT-100 kits purchased. EpiOcular™ lot no. 21597
- Doses of test chemical and control substances used: 50 μL of undiluted test item, methyl acetate or deionised water.
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable): 30 minutes exposure at 37 ± 1.5 ºC; post-exposure immersion for 12 minutes at room temperature; post-exposure incubation for 120 minutes at 37 ± 1.5 ºC
- Justification for the use of a different negative control than ultrapure H2O (if applicable): Not applicable
- Justification for the use of a different positive control than neat methyl acetate (if applicable): Not applicable
- Description of any modifications to the test procedure: None
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable): Not applicable
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable): 2 per test item, postive control or negative control.
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer): Measured at 570 nm with a microplate reader without a reference filter. Absorbance values calculated with computer software.
- Description of the method used to quantify MTT formazan:
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable): Not applicable
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: If the test item-treated tissue viability is > 60 % relative to the negative control treated tissue viability, the test item is labelled non-irritant. If viability is ≤ 60 % of treated negative control, the test item is labelled irritant.
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria:
- Complete supporting information for the specific RhCE tissue construct used: Method validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe between 2008 and 2013.
- Reference to historical data of the RhCE tissue construct: Historic data from July 2015 to February 2016 show the postive control range of viabiltiies of 6.90 % - 40. 4 %. The range of absorbance for historic postive control data is 0.107 - 0.849 and for negative control data 1.27 - 2.05.
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals: Historical report data reported.
- Positive and negative control means and acceptance ranges based on historical data: Positve control - mean viability: 32.0 %, range: 6.90 - 40.4 %, mean absorption: 0.538, range 0.107 - 0.849. Negative control - mean absorption: 1.65, range 1.27 - 2.05
- Acceptable variability between tissue replicates for positive and negative controls: < 20 %
- Acceptable variability between tissue replicates for the test chemical: < 20 % - Irritation parameter:
- other: Mean absorbance
- Run / experiment:
- 2 Tissues
- Value:
- 2.025
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Relative absorbance (% of negative control)
- Run / experiment:
- Mean of 2 tissues
- Value:
- 100.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: Validity criteria met
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Negative control OD is > 1.0 and < 2.5 (1.99 and 2.053). The difference of viability between the two relating tissues of the postive control was 3.1 % (must be < 20%)
- Acceptance criteria met for positive control: Mean relative viability of the positive control is below 50% of the negative control viability (40.4%). The difference of viability between the two relating tissues of the postive control was 3.2 % (must be < 20%)
- Range of historical values if different from the ones specified in the test guideline: Not applicable - Irritant / corrosive response data:
- Irritating effects were not observed following 30 minutes incubation with the test item.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, under the experimental conditions reported, the test item does not possess an eye irritating potential.
- Executive summary:
The test item was assessed for eye irritation in a human cornea model test conducted following OECD 492, and UN GHS guidelines in undiluted form alongside a postive and negative control. The results of the test indicates that the test item does not possess an eye irritating potential according to the UN GHS regulations.
The study is a GLP compliant guideline experiment study available as an unpublished study report. The study has no restrictions and is fully adequate for assessment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test item was assessed for skin irritation in a human skin model test conducted following OECD 439, EU B.46 and UN GHS guidelines in undiluted form alongside a postive and negative control. The results of the test indicate that the test item is a Category 2 irritant to skin according to the UN GHS regulations.
The test item was assessed for eye irritation in a human cornea model test conducted following OECD 492, and UN GHS guidelines in undiluted form alongside a postive and negative control. The results of the test indicates that the test item does not possess an eye irritating potential according to the UN GHS regulations.
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