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EC number: 805-659-5 | CAS number: 848820-98-4
- 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:
- March - April 2014
- Reliability:
- 1 (reliable without restriction)
- 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)
- Type of coverage:
- other: Commercially available Epi-200-Kit
- Irritation / corrosion parameter:
- other: erythema score
- Value:
- >= 1
- Remarks on result:
- other:
- Remarks:
- Time point: 2014. (migrated information)
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Three tissues of the human skin model EpiDermTMwere treated with KCCS DOB11 for 60 minutes.
30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier).
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 0.8≤mean OD≤2.8. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).
After the treatment with the test item, the relative absorbance values were reduced to 3.3 %. This value is well below the threshold for irritation potential (50%).
Therefore, KCCS DOB11 is considered as “irritant in the Human Skin Model Test”.
In the UN GHS System for skin irritating substances, KCCS DOB11should be classified in UN GHS category 2.
Reference
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:
- May - June 2014
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Interpretation of results:
- other: KCCS DOB11 induces effects on the cornea. It cannot be classified in a UN GHS Category for eye damage. Because of the negative test result a sequential testing strategy is necessary.
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- A mean IVIS of 3.396 was calculated. Under the conditions of this test, the test item KCCS DOB11 showed effects on the cornea of the bovine eye. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in a UN GHS Category for eye damage.
- Executive summary:
One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item KCCS DOB11 was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32±1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32±1 °C. After removal of the test item, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.
20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea.
Under the conditions of this test, the test item KCCS DOB11 showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 3.396. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and≤ 55 cannot be classified in a UN GHS Eye Damage Category.
Reference
Opacity and Permeability Values
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Parameter |
Negative Control |
||
Absorption before exposition |
0.1532 |
0.1552 |
0.1546 |
Absorption after exposition |
0.3141 |
0.1982 |
0.2154 |
Opacity before exposition |
1.4230 |
1.4296 |
1.4276 |
Opacity after exposition |
2.0611 |
1.5783 |
1.6421 |
Opacity Difference |
0.6381 |
0.1488 |
0.2145 |
Mean opacity difference of the negative control is 0.3338.
Absorption and Opacity Values Test Item and Positive Control
Parameter |
Test Item KCCS DOB11 |
Positive Control |
||||
Absorption before exposition |
0.1691 |
0.1434 |
0.2106 |
0.1500 |
0.1336 |
0.1624 |
Absorption after exposition |
0.5621 |
0.6625 |
0.8231 |
1.8089 |
2.0742 |
2.1406 |
Opacity before exposition |
1.4760 |
1.3912 |
1.6241 |
1.4125 |
1.3602 |
1.4534 |
Opacity |
3.6484 |
4.5973 |
6.6543 |
64.4021 |
118.6315 |
138.2293 |
Opacity |
2.1723 |
3.2060 |
5.0302 |
62.9896 |
117.2713 |
136.7758 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Repl. |
Negative Control |
Test Item KCCS DOB11 |
Positive Control |
||||||
Meas. |
0.0043 |
0.0041 |
0.0060 |
0.0089 |
0.0072 |
0.0087 |
0.1856 |
0.1992 |
0.1594 |
Corr. |
0.0215 |
0.0205 |
0.0300 |
0.0445 |
0.0360 |
0.0435 |
0.9280 |
0.9960 |
0.7970 |
Mean |
0.0240 |
-- |
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.961 |
0.694 |
36.5 % |
0.456 |
|||
0.665 |
|||
Test Item |
2.146 |
3.396 |
42.8 % |
3.052 |
|||
4.989 |
|||
Positive Control |
76.216 |
118.590 |
31.7 % |
131.518 |
|||
148.037 |
Classification
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS >3 and≤ 55 induces effects on the cornea, that cannot be classified in a UN GHS Category.
IVIS |
UN GHS Category Eye Damage |
≤ 3 |
No Category |
> 3;≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed. The positive control showed seriouseye damage.
The test item KCCS DOB11 showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 3.396.
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean. The negative or solvent control has to show an IVIS between 0 and 3.
The validity criteria and findings are given in the following table:
Parameter |
Criterion |
Found |
Assessment |
IVIS of negative control 0.9% NaCl |
0 - 3 |
0.694 |
ok |
IVIS of positive control |
35.6 - 130.4 |
118.590 |
ok |
Two values of the positive control were not within the range of historical data of the test facility.This can be seen as uncritical because difference was marginal and the mean value was within the demanded range as well as within historical data. The study is considered as valid, because only one replicate of the test item gave a discordant prediction from the mean whereas the other two led to same assessment for the test item. The discordant replicate showed a value far below 65.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Skin irritation
KCCS DOB11 is considered as “irritant in the Human Skin Model Test” following EU-Method B.46 resp. OECD 439.
Eye irritation
The test item KCCS DOB11 was brought onto the cornea of a bovine eye. A mean IVIS of 3.396 was calculated. Under the conditions of this test, the test item KCCS DOB11 showed effects on the cornea of the bovine eye. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and≤ 55 cannot be classified in a UN GHS Eye Damage Category.
Because of the negative BCOP test result another in vitro test has been performed (the Human Cornea Model test).
Although the Human Cornea Model test has not been validated by ECVAM so far the test item KCCS DOB11 is considered as not/minimal eye irritant based on both test results (BCOP and the Human Cornea Model).
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