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EC number: 272-902-4 | CAS number: 68919-76-6
- 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
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:
- 2012-09-25 to 2013-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD 439 and EU method B.46 in a GLP certified testing facility.
- 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
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 microliter
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter
- Concentration (if solution): - Duration of treatment / exposure:
- 35 minutes at 37°C
- Number of replicates:
- 3 for each sample and control
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- formation of formazan from MTT was determined being a measure of cell viability.
- Run / experiment:
- 1
- Value:
- 3.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- formation of formazan from MTT was determined being a measure of cell viability.
- Run / experiment:
- 2
- Value:
- 3.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 4.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value refers to % formazan production
- Interpretation of results:
- other: irritant according to EU regulation
- Conclusions:
- 400112 is considered irritant in the Human Skin Model Test.
- Executive summary:
To determine the Skin Irritation Potential of 400112 the Human Skin Model Test following EU-Method 8.46 resp. OECD 439 was conducted.
Three tissues of the human skin model EpiDerm™ were treated with the test item 400112 for 60 min. 30 µL of the liquid lest item were applied to each tissue (using a nylon mesh) and spread to match the tissue size (0.63 cm²). DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable for the positive and negative control (< 18%).
After the treatment with the test item 400112, the relative absorbance values were reduced to 3.9%. This value is well below the threshold for irritation potential (50%).
Therefore, 400112 is considered as irritant in the Human Skin Model Test.
Reference
Blank:
As blank, the optical density of isopropanol was measured in eight wells of the 96-wellplate.
Mean value:0.061
Table 1: Absorption values of the negative control, test item and positive control (OD at 570 nm)
Tissue no. |
Measurement |
Negative Control |
400112 |
Positive Control |
1 |
1 |
2.132 |
0.429 |
0.214 |
2 |
2.151 |
0.425 |
0.211 |
|
2 |
1 |
2.044 |
0.440 |
0.215 |
2 |
2.084 |
0.445 |
0.216 |
|
3 |
1 |
2.028 |
0.452 |
0.222 |
2 |
2.044 |
0.469 |
0.225 |
From the measured absorption values, the mean of each tissue was calculated. From the mean absorption values the mean absorption of isopropanol (0.061) was subtracted. Mean and relative standard deviations (comparison of the three tissues) were also calculated.
Table 2: Mean absorption values subtracted by the mean absorption of the blank
Tissue no. |
Negative Control |
400112 |
Positive Control |
1 |
2.081 |
0.366 |
0.152 |
2 |
2.003 |
0.382 |
0.155 |
3 |
1.975 |
0.400 |
0.163 |
Mean of the three tissues |
2.020 |
0.383 |
0.157 |
Relative standard deviation |
2.7% |
4.4% |
3.6% |
Table 3: Mean absorption values of freeze killed tissues of negative control and test item (OD at 570 nm)
Tissue no. |
Negative Control |
400112 |
1 |
0.093 |
0.380 |
2 |
0.087 |
0.400 |
3 |
0.088 |
0.399 |
Mean of the three tissues |
0.090 |
0.393 |
The mean OD of the untreated freeze-killed tissue is subtracted from the mean OD of the treated freeze-killed tissue (= 0.304). This difference is then subtracted from the OD of the test item in the test. The calculated value is the “OD corrected”.
Corrected Values Viable Tissues
The absorption values of the negative and positive control and the corrected absorption values of the test item are given in the following table:
Table 4: Mean absorption values
Tissue no. |
Negative Control |
400112 (corrected) |
Positive Control |
1 |
2.081 |
0.062 |
0.152 |
2 |
2.003 |
0.078 |
0.155 |
3 |
1.975 |
0.096 |
0.163 |
Mean of the three tissues |
2.020 |
0.079 |
0.157 |
Relative standard deviation of the three tissues |
2.7% |
21.3% |
3.6% |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:
Table 5: % Formazan production
Tissue no. |
400112 |
Positive Control |
1 |
3.1% |
7.5% |
2 |
3.9% |
7.7% |
3 |
4.8% |
8.1% |
Mean of % formazan production |
3.9% |
7.8% |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-05 to 2012-11-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guideline 405 and EU method B.5 in a GLP-certified testing facility.
- 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
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One male albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste -F40260 Linxe).
Acclimatisation period: minimal 5-days
Age at the beginning of the test: 14 weeks
Body weight during the test: between 2.89 kg and 3.12 kg.
The animal was identified prior to inclusion in the test by means of a numbered ring on the edge of
one ear.
Housing: individual box installed in conventional air conditioned animal husbanding:
Temperature: 17 to 23°C
Relative humidity: 30 to 70%
Rate of air exchange: approximately between 10-15 changes per hour
Lighting: 12 h continuous light (07.00 to 19.00) and 12 h darkness.
Drinking water (tap-water from public distribution system) and foodstuff (SAFE- 112) were supplied freely. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of of the animal remained untreated serving as control
- Amount / concentration applied:
- 0.1 mL of test item was used, as supplied.
- Duration of treatment / exposure:
- 3 days
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 3.7
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 2
- Remarks on result:
- other: examination of "redness"
- Irritation parameter:
- iris score
- Remarks on result:
- other: The iris was not visible between day 0 (1 hour after instillation) and day 3.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of scores at examinations after 1 h, 48 h and 72 h
- Score:
- 4
- Max. score:
- 4
- Other effects:
- White secretions requiring a physiological rinse was noted on days 2 and 3.
A brown coloration of the nictitating membrane was noted 1 hour after the test item application.
For ethical reasons, the animal was euthanized on day 3. - Interpretation of results:
- other: Category 1, causes serious eye damage according to EU regulation
- Conclusions:
- Based on the results of this in vivo test the test item 400112 must be classified according to Regulation (EC) No. 1272/2008 in category 1 "serious eye damage".
- Executive summary:
The test item 400112 was instilled as supplied, into the eye of one New Zealand rabbit at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 405 dated April 24th, 2002 and the test method B.5 of the council regulation No. 440/2008.
The ocular reactions observed during the study have been moderate to severe and were not reversible.
For ethical reasons, the animal was euthanized on day 3.
In accordance with the Regulation (EC) No. 1272/2008, the test item must be classified in category 1 "causes serious eye damage".
Reference
Animal n° |
Time aftertreatment |
CONJUNCTIVAE |
IRIS |
CORNEA |
|
CHEMOSIS |
REDNESS |
LESION |
OPACITY |
||
A2405 |
24h |
3 |
2 |
|
4 |
48h |
4 |
2 |
|
4 |
|
72h |
4 |
2 |
|
4 |
|
TOTAL |
11 |
6 |
|
12 |
|
Mean |
3.7 |
2.0 |
|
4.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the in vitro skin irritation test, 400112 is must be classified in category 2 "Causes skin irritation".
Based on the results of the in vivo eye irritation test, 400112 must be classified in category 1 "causes serious eye damage" according to Regulation (EC) No. 1272/2008.
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