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EC number: 871-500-1 | CAS number: 2268679-24-7
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
Skin and eye irritation of the substance
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:
- From 28 November 2012 to 30 November 2012
- 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)
- Version / remarks:
- 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed epidermis of normal human keratinocytes.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE/S/17
- Tissue batch number(s): 12 022A 1103
- Certificate of analysis of reconstructed human epidermis date: 2012-11-26
- Delivery date: recevied on 2012-11-27
- Expiration date : 2012-12-03
- Date of initiation of testing: 2012-11-28
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 x 1 mL with PBS
- Observable damage in the tissue due to washing: 1 of the replicate was compromised.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hr
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the tissue viability after 42 minutes exposure and 42 hrs of post-treatment incubation is < than 50%.
- The test substance is considered to be non-corrosive to skin if the tissue viability after 42 minutes exposure and 42 hrs of post-treatment incubation is > 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): 16 mg
NEGATIVE CONTROL : PBS - Pan BIOTECH GmbH - in the same experimental conditions
POSITIVE CONTROL : 5% SDS CAS 151-21-3 (0.5 g SDS in a 10 mL volumetric flask qsp 10 mL distilled water), in the same experimental conditions. - Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 42 hrs
- Number of replicates:
- 3 replicates
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 1 (skin #7)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: aberrants values
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 2 (skin #8)
- Value:
- ca. 76
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 3 (skin #9)
- Value:
- ca. 96.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean valibility = 100 %
- Acceptance criteria met for positive control: mean viability = 1.2 % - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item must not be classified, in accordance with the Regulation EC No. 1272/2008.
- Executive summary:
The aim of the study was to evaluate the possible irritating effects of the test item after topical administration on in vitro human reconstructed epidermis (RHE® model). The test item was applied, as supplied, at the dose of 16 mg, to 3 Reconstructed Human epidermis small during 42 minutes, followed by a 42 hours postincubation period at 37°C, 5% C02.
The elimination of the test item on the epidermis after treatment was difficult. Even after a rinse with 35 mL of PBS, there was remaining test item. The first epidermis was compromised during rinsing and was not taken into account for the classification of the test item.
The experimental protocol was established in accordance with OECD guideline No. 439 adopted 22 July 2010 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220)-ATP Council regulation No. 4401/2008 of 30 May 2008 (E. U. Journal L142).
The mean viability ofthe epidermis skins was 86.3%, versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate ).
The results obtained, under these experimental conditions, enable to conclude that in accordance with the Regulation EC No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the structural similarity between the source and the target substances. Their skin toxicity are expected to be similar because of this structural similarity (see document attached).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target and the source substances are structurally related, and have the same impurity profile. Therefore, it is concluded that the impurities will not affect the read-across (see document attached).
3. ANALOGUE APPROACH JUSTIFICATION
In the absence of a skin irritation study on the target substance, a read-across using experimental study performed on source substance was used. Based on structural similarity and a similar impurity profile, no significant difference on their skin irritation toxicity potential is anticipated between both the target and the source substances (see document attached). Therefore, the skin irritation study conducted with the source substance is highly likely to predict the properties of the target substance and is considered as adequate to fulfil the information requirement.
4. DATA MATRIX
See document attached - Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- -
- Value:
- >= 76 - <= 96.6
- Vehicle controls validity:
- not applicable
- Remarks:
- read-across
- Negative controls validity:
- not applicable
- Remarks:
- read-across
- Positive controls validity:
- not applicable
- Remarks:
- read-across
- Remarks on result:
- no indication of irritation
- Remarks:
- by read-across
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the source subtance, the target substance must not be classified, in accordance with the Regulation EC No. 1272/2008.
- Executive summary:
The irritating potency of the target substance has been determined according to the OECD guideline No. 439 adopted 22 July 2010 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220)-ATP Council regulation No. 4401/2008 of 30 May 2008 (E. U. Journal L142), performed on the source substance.
The test item was applied, as supplied, at the dose of 16 mg, to 3 Reconstructed Human epidermis small during 42 minutes, followed by a 42 hours postincubation period at 37°C, 5% C02.
The elimination of the test item on the epidermis after treatment was difficult. Even after a rinse with 35 mL of PBS, there was remaining test item. The first epidermis was compromised during rinsing and was not taken into account for the classification of the test item.
The mean viability of the epidermis skins was 86.3%, versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate ).
The results obtained, under these experimental conditions, enable to conclude that in accordance with the Regulation EC No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
Based on the result, the source and target substances must not be classified, in accordance with the Regulation EC No. 1272/2008.
Referenceopen allclose all
Individual and average values of OD after 42 minutes of exposure:
|
Skin |
OD |
Mean OD/disc (Mean of the 3 OD measurements) |
Mean OD/ product |
Viability % |
Mean Viability % |
SD |
Conclusion |
Negative Control |
1 |
1.041 1.100 1.138 |
1.093 |
1.031* |
106.0 |
100.0 |
5.9 |
|
2 |
0.961 1.039 1.092 |
1.030 |
99.9 |
|||||
3 |
0.908 0.976 1.029 |
0.971 |
94.1 |
|||||
Positive Control |
4 |
0.012 0.014 0.013 |
0.013 |
0.013 |
1.3 |
1.2 |
0.1 |
Irritant |
5 |
0.011 0.013 0.012 |
0.012 |
1.2 |
|||||
6 |
0.013 0.012 0.014 |
0.013 |
1.3 |
|||||
Test Item |
7 |
0.216 0.243 0.250 |
0.236 – Aberrant values |
|
|
|
|
|
8 |
0.763 0.761 0826 |
0.783 |
0.890 |
76.0 |
86.3* |
14.6* |
Non irritant |
|
9 |
0.918 1.030 1.040 |
0.996 |
96.6 |
* The result is based on two tissues replicates (n° 8 and 9) instead of three as initially scheduled in the study plan. The rinsing of the epidermises in view to eliminate the test item after treatment was difficult and required more rinsing with PBS than usually. The first treated epidermis was compromised during this rinsing step and was not taken into account for the classification of the test item.
Negative control and positive control are in the expected range.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- 2012-11-05
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: eyes from chickens freshly killed
- Details on test animals or tissues and environmental conditions:
- TEST EYES
- Source: Slaughterhouses Etablissement Brun, 33820 Etaulier, France
- Age of the donors animals: approximately 7 weeks old
- Weight of the donors animals: between 1.5 to 2.5 kg
- Transport of eyes: The intact heads were transported from the slaughterhouse at ambient temperature in polystrene boxes humidified with towels moistened with isotonic saline. The eyes are enucleated in the laboratory within less than 1h30 after the the heads are removed
- Time between collection and use of corneas:The corneas were transported to the laboratory straight after removal on animals and used in a maximum delay of 24 hours after reception at the laboratory. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 30 mg - Duration of treatment / exposure:
- Treatment of 10 secondes
- Observation period (in vivo):
- 4 hours post-treatment
- Number of animals or in vitro replicates:
- 3 chicken eyes for the treatment group
3 chicken eyes for the positive control group
1 chicken eye for the negative control group - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 40 mL of physiological saline (4 times for the treatement group and 2 times for the control groups)
- Time after start of exposure: after 10 secondes
SCORING SYSTEM: Determination of ICE classes for 3 endpoints (1- corneal thickness, 2- corneal opacitiy, 3- fluorescein retention) according to a predefine range. Each ICE classes are then combined to generate an Irritancy Classification
TOOL USED TO ASSESS SCORE:
- Corneal thickness : quantitative determination by optical pachymeter on a slit-lamp microscope.
- Corneal opacity: qualitative assessment based on the area of the cornea opacified
- Fluorescein retention : qualitative assessment based on the staining of the cornea - Irritation parameter:
- cornea opacity score
- Remarks:
- maximal mean score
- Value:
- ca. 0.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean score
- Value:
- ca. 0.8
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class II
- Irritation parameter:
- corneal swelling
- Remarks:
- maximal mean (+ in %)
- Value:
- ca. 10
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class II
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no morphological effects were noted, whatever the examination time
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the combinaison of the 3 endpoints was 3 x class I: classified as non corrosive/severe irritant.
- Acceptance criteria met for positive control: the combinaison of the 3 endpoints was 3 x class IV: classified as corrosive/severe irritant.
- Range of historical values if different from the ones specified in the test guideline: - Interpretation of results:
- not irritating
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item must not be classified the test item must not be classified in category l "irreversible effects on the eye", in accordance with the Regulation (EC) No. 1272/2008, The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required.
- Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chickeh eyes.
The test item was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. As there was remaining test item, the eyes were rinsed again twice with 10 mL of physiological saline. Test item remained on the cornea of one eye during all the study and on another eye up to the observation time 2 hours.
Three eyes were treated in the same manner (except for a rinse twice with 10 mL of physiological saline) with a positive control and one eye with a negative control. Damages by the test substance were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the O.E.C.D. guideline No 438 adopted 07 September 2009 and the test method B.48 - Commission Regulation (EU) No. 1152/2010 dated 08 December 2010 (EU Journal L324) - ATP Council regulation No 440/2008 of 30 May 2008 (E. U Journal L142).
The ocular reactions observed in eyes treated with the test item were slight to moderate:
- maximal mean score of corneal opacity: 0.2, corresponding to the ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to the ICE class II;
- maximal mean corneal swelling: +10%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, 10 % sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as corrosive/severe irritant, as expected.
The combination of the three endpoints for the negative control, physiological saline solution, was 3 x I. Therefore, the negative control is classified as non corrosive/severe irritant, as expected.
The results obtained, under these experimental conditions, enable to conclude that the test item must not be classified in category l "irreversible effects on the eye", in accordance with the Regulation (EC) No. 1272/2008.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the structural similarity between the source and the target substances. Their eye toxicity are expected to be similar because of this structural similarity (see document attached).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target and the source substances are structurally related, and have the same impurity profile. Therefore, it is concluded that the impurities will not affect the read-across (see document attached).
3. ANALOGUE APPROACH JUSTIFICATION
In the absence of a eye irritation study on the target substance, a read-across using experimental study performed on source substance was used. Based on structural similarity and a similar impurity profile, no significant difference on their eye irritation toxicity potential is anticipated between both the target and the source substances (see document attached). Therefore, the eye irritation study conducted with the source substance is highly likely to predict the properties of the target substance and is considered as adequate to fulfil the information requirement.
4. DATA MATRIX
See document attached - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Remarks:
- maximal mean score
- Value:
- ca. 0.2
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean score
- Value:
- ca. 0.8
- Remarks on result:
- other: ICE class II
- Irritation parameter:
- corneal swelling
- Remarks:
- maximal mean (+ in %)
- Value:
- ca. 10
- Remarks on result:
- other: ICE class II
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the source subtance, the target substance must not be classified, in accordance with the Regulation EC No. 1272/2008.
- Executive summary:
The irritating potency of the target substance has been determined according to the OECD guideline No. 438 adopted 07 September 2009 and the Test method B.48 of Council regulation No. 1152/2010 dated 08 December 2010 (EU Journal L324)-ATP Council regulation No. 4401/2008 of 30 May 2008 (E. U. Journal L142), performed on the source substance.
The test item was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. As there was remaining test item, the eyes were rinsed again twice with 10 mL of physiological saline. Test item remained on the cornea of one eye during all the study and on another eye up to the observation time 2 hours.
Three eyes were treated in the same manner (except for a rinse twice with 10 mL of physiological saline) with a positive control and one eye with a negative control. Damages by the test substance were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The ocular reactions observed in eyes treated with the test item were slight to moderate:
- maximal mean score of corneal opacity: 0.2, corresponding to the ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to the ICE class II;
- maximal mean corneal swelling: +10%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, 10 % sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as corrosive/severe irritant, as expected.
The combination of the three endpoints for the negative control, physiological saline solution, was 3 x I. Therefore, the negative control is classified as non corrosive/severe irritant, as expected.
Based on the result of the source subtance, the target substance must not be classified, in accordance with the Regulation EC No. 1272/2008.
Referenceopen allclose all
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
Skin irritation / corrosion:
An EpiSkin study was conducted on the source substance according to guidelines OECD 439 and EC B.46.
The results obtained (mean viability ofthe epidermis skins was 86.3%, versus 1.2% in the positive control) enable to conclude the substance must not be classified as "irritating".
In the sensitization study performed on the source substance, it was not considered as an irritant (erythema score < 3).
Eye irritation:
An Isolated Chicken Eye Test was conducted with the source substance according to guidelines OECD 438 and EC B.48.
While the results (slight to moderate ocular reactions) enable to conclude that the source substance must not be classified R41 "Risk of serious damage to eyes" or in category 1 "irreversible effects on the eye", it was not possible to conclude that the substance does not require classification for eye irritation or serious eye damage.
Above all, there are some uncertainties on the issue of the test and on its application domain.
First, the ICE test method does not consider conjunctival and iridal injuries, but it addresses only corneal effects. Based on in vivo test performed on other organic dye of the same group, the main corrosives effects are observed on the conjunctive and the iris, with moderated effects on the cornea.
Moreover, the applicability domain for this category of substance cannot be assessed as no comparison with an appropriate database was performed.
Consequently, the results are doubtful and very likely under-estimated and further tests are needed to evaluate this endpoint.
In the past, the Bovine Corneal Opacity and Permeability Test Method (OECD 439) – BCOP – has been performed on another organic dye of the same category. Because of the coloring strength of the dye and the uncertainty of the applicability domain of the BCOP test method the result was inconclusive.
To conclude, no in vitro tests seems to be appropriate to evaluate the eye irritancy and/or corrosivity of the source substance (coloring strength and uncertainties due to the applicability domain of the tests), and to avoid unnecessary in vivo test on rabbit, the source substance has been classified corrosive for the eye.
By read-across, the target substance is classified corrosive for the eye.
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.