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EC number: 607-674-0 | CAS number: 25260-60-0
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Sediment toxicity
- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
RHE test in vitro, OECD 439: no skin irritation (reference 7.3.1 -1)
BCOP assay in vitro, OECD 437: no conclusion can be made (reference 7.3.2.-1)
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:
- 2014-10-02 to 2015-01-29
- 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.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended system by the guidelines
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Reconstructed Human Epidermis (RHE Kit)
- Tissue batch number: 14-RHE-024
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsing with minimum of 25 mL
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours +/- 5 min
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: well
- Barrier function: checked
- Morphology: well
- Contamination: none
- Reproducibility: well
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to skin if the viability after 42 minutes exposure is less or equal to 50%
- The test substance is considered to be non-irritating to skin if the viability after 42 minutes exposure is greater than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 µL
NEGATIVE CONTROL
- Amount applied: 16 µL
POSITIVE CONTROL
- Amount applied: 16 µL
- Concentration: 5 % aqueous solution - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 63.77
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: not applicable
- Colour interference with MTT: not applicable
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test item is considered to be not irritating to human skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Reconstructed Human Epidermis Test according to OECD TG 438. The test consisted of a topical administration of the test item to a human reconstructed skin model followed by a cell viability test. Cell viability was quantitatively measured by dehydrogenase conversion of MTT into a blue formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the skin irritation potential. Triplicates of the human skin RHE™-model were treated with the test item, the negative or the positive control for 42 minutes (± 1 minute). 16 µL of either the negative control (DPBS-buffer), positive control (5% aqueous solution of sodium dodecyl sulfate) or test item were applied to the tissues.
After treatment with the negative control (DPBS-buffer) the mean OD was 2.515. Treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) revealed a mean viability value of 0.83%. Therefore, the study fulfilled the validity criteria.
The tissue viability after treatment with the test item was 63.77 % and, thus, higher than 50 %, i.e. according to UN GHS classification the test item is considered as non-irritant to skin.
In conclusion, under the conditions of this study, the test item is not considered to possess an irritant potential to skin.
Reference
Table 1 Results obtained after in RHE assay
Dose |
Treatment |
Optical |
Optical |
Optical |
Mean optical |
Mean relative |
Standard deviation (SD) in % |
Negative |
42 min |
2.445 |
2.588 |
2.510 |
2.515 |
100.00 |
2.85 |
Positive |
42 min |
0.022 |
0.021 |
0.021 |
0.021 |
0.83 |
2.77 |
Test item |
42 min |
1.571 |
1.634 |
1.606 |
1.604 |
63.77 |
1.97 |
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:
- 2014-10-09 to 2015-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Odenwaldschlachthof Brensbach, 64395 Brensbach, Germany
- Characteristics of donor animals:
age: 18-30 months
corneal diameter: 24-26 mm
- Storage, temperature and transport conditions of ocular tissue:
Freshly isolated bovine eyes of donor cattle were collected from the slaughterhouse. Excess tissue was removed from the eyes. The eyes were kept and transported in transport medium cooled on ice.
Transport medium: HBSS (Hanks' Balanced Salt Solution)
- Time interval prior to initiating testing:
The corneas were prepared immediately after delivery of the eyes to the laboratory.
- indication of any existing defects or lesions in ocular tissue samples: All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity or scratches were discarded.
- Indication of any antibiotics used: Streptomycin and Penicillin was added for the transport (5 mL/500 mL HBSS). - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 mL
- Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 120 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The corneas were prepared immediately after delivery of the eyes to the laboratory. The corneas were carefully removed from the eyes using scalpel and rounded scissors. A rim of about 2 to 3 mm of tissue (sclera) was left for stability and handling of the isolated cornea. All corneas used in the study were collected in incubation medium (prewarmed at 32 ± 1°C) and the corneal diameter of each cornea was measured and recorded. Each cornea was mounted in a cornea holder with the endothelial side against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring without stretching the cornea. Afterwards, the anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first to return the cornea to its natural convex form.
QUALITY CHECK OF THE ISOLATED CORNEAS :
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity or scratches were discarded.
NUMBER OF REPLICATES : 3
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3 washing steps
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity
- Corneal permeability: passage of sodium fluorescein dye
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: as indicated in the TG - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 12.2
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of this study alone no conclusion can be made in regards to eye irritation/corrosion properties of the test item.
- Executive summary:
This in vitro study was performed to evaluate the eye hazard potential of the test item by means of the BCOP (Bovine Corneal Opacity and Permeability Assay). Therefore, the induced opacity and increased permeability was investigated in isolated bovine corneas after exposure to the test item. As negative control 0.9% sodium chloride solution and as positive control N,N-dimethylformamide was used. Three corneas were used per group (negative control, positive control or test item group).
After a first opacity measurement of the untreated bovine corneas, 750 µL of the test item, positive or negative control were applied on the corneas and incubated for 10 minutes. After the incubation phase the test item, the positive, and the negative control were rinsed from the corneas and the opacity was measured again. After the opacity measurements, the permeability of the corneas was determined by application of a fluorescein solution for 90 minutes. The amount of fluorescein solution that crossed the cornea was measured spectrophotometrically. The opacity and permeability assessments were combined to determine an In Vitro Irritancy Score (IVIS). After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 2.8. Treatment with the positive control (N,N-dimethylformamide) revealed an IVIS of 105.0. Therefore, the study fulfilled the validity criteria. The IVIS obtained after treatment with the test item was 12.2 and, thus, according to OECD 437 no prediction can be made regarding the eye hazard potential.
In conclusion, under the conditions of the present study, no prediction can be made for the test item with regard to the eye hazard potential.
Reference
Table 1 Summary of results of BCOP assay
|
|
|
|
IVIS |
||
|
|
Opacity |
Permeability |
per cornea |
per group |
Standard |
Negative
|
0.9% sodium |
3.702 |
-0.002 |
3.667 |
28 |
18 |
|
4.050 |
-0.002 |
4.020 |
|||
|
0.629 |
0.002 |
0.659 |
|||
Positive
|
N,N- Dimethylformamide |
86.937 |
0.821 |
99.254 |
1050 |
5.8 |
|
84.609 |
1.339 |
104.696 |
|||
|
84.439 |
1.766 |
110.925 |
|||
Test Item |
|
12.089 |
-0.001 |
12.037 |
12.2 |
2.8 |
9.391 |
0.008 |
9.508 |
||||
15.008 |
0.007 |
15.119 |
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in vitro, reference 7.3.1-1
This in vitro study was performed to assess the irritation potential of the test item by means of the Reconstructed Human Epidermis Test according to OECD TG 439. The test consisted of a topical administration of the test item to a human reconstructed skin model followed by a cell viability test. Cell viability was quantitatively measured by dehydrogenase conversion of MTT into a blue formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the skin irritation potential. Triplicates of the human skin RHE™-model were treated with the test item, the negative or the positive control for 42 minutes (± 1 minute). 16 µL of either the negative control (DPBS-buffer), positive control (5% aqueous solution of sodium dodecyl sulfate) or test item were applied to the tissues.
After treatment with the negative control (DPBS-buffer) the mean OD was 2.515. Treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) revealed a mean viability value of 0.83%. Therefore, the study fulfilled the validity criteria. The tissue viability after treatment with the test item was 63.77 % and, thus, higher than 50 %, i.e. according to UN GHS classification the test item is considered as non-irritant to skin.
In conclusion, under the conditions of this study, the test item is not considered to possess an irritant potential to skin.
Eye irritation in vitro, reference 7.3.2 -1
This in vitro study was performed to evaluate the eye hazard potential of the test item by means of the BCOP (Bovine Corneal Opacity and Permeability Assay), according to OECD 437. Therefore, the induced opacity and increased permeability was investigated in isolated bovine corneas after exposure to the test item. As negative control 0.9% sodium chloride solution and as positive control N,N-dimethylformamide was used. Three corneas were used per group (negative control, positive control or test item group).
After a first opacity measurement of the untreated bovine corneas, 750 µL of the test item, positive or negative control were applied on the corneas and incubated for 10 minutes. After the incubation phase the test item, the positive, and the negative control were rinsed from the corneas and the opacity was measured again. After the opacity measurements, the permeability of the corneas was determined by application of a fluorescein solution for 90 minutes. The amount of fluorescein solution that crossed the cornea was measured spectrophotometrically. The opacity and permeability assessments were combined to determine an In Vitro Irritancy Score (IVIS). After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 2.8. Treatment with the positive control (N,N-dimethylformamide) revealed an IVIS of 105.0. Therefore, the study fulfilled the validity criteria. The IVIS obtained after treatment with the test item was 12.2 and, thus, according to OECD 437 no prediction can be made regarding the eye hazard potential.
In conclusion, under the conditions of the present study, no prediction can be made for the test item with regard to the eye hazard potential.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data the test item does not require classification as skin
irritanting according to Regulation (EC) No 1272/2008 (CLP), as amended
for the twelfth time in Regulation (EU) 2019/521.
Regarding eye irritation, no final conclusion can be made based on the available data.
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