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EC number: 293-428-4 | CAS number: 91079-40-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Peptones, casein
- EC Number:
- 293-428-4
- EC Name:
- Peptones, casein
- Cas Number:
- 91079-40-2
- Molecular formula:
- Not applicable
- IUPAC Name:
- Peptones, casein
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (fresh bovine corneas)
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2.4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01 % streptomycin and 0.01 % penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1°C in an incubation chamber for 1 hour.
Test system
- Vehicle:
- other: 0.9 % sodium chloride solution
- Controls:
- yes
- Amount / concentration applied:
- 750 µl of the test item solution (concentration of 10 % in a 0.9 % sodium chloride solution) were used.
- Duration of treatment / exposure:
- Exposition time on the corneas was 10 minutes at 32°C.
- Observation period (in vivo):
- 2 hours post-incubation after the removal of the test item.
- Number of animals or in vitro replicates:
- no data
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): thorough rinsing with cMEM (complete Minimum Essential Medium) with phenol red and final rinsing with cMEM without phenol red
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- Calculation of Opacity Value: Opacity was calculated from the measured absorption at 570 nm following:
0 = 1/10^(-A) with 0 = Opacity / A= Absorption at 570 nm
The difference between opacity before and after exposition is used for further evaluation.
- Correction of Measured Absorption at 490 nm: As cuvettes with a pathlength of 0.2 cm are used in the measurement of the FluoresceinNa solution in the spectral photometer, the pathlength must be corrected to 1 cm. Coefficient: 1/0.2 = 5: all absorptions were multiplied with this coefficient.
- Calculation of IVIS (In Vitro Irritancy Score): The IVIS of each replicate of the negative control was calculated from the following equation:
IVIS = opacity difference + (15 x corrected OD490 value)
The IVIS of each replicate of the positive control and of the test item were calculated from the following equation:
IVIS = (opacity difference - mean opacity difference of the negative controls) + [15 x (corrected OD490 - mean corrected OD490 of the negative controls)]
Note: All calculations are performed with unrounded values. Therefore, re-calculation with rounded values may lead to slightly different results.
TOOL USED TO ASSESS SCORE: fluorescein-Na solution
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 1.64
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Opacity and permeability values:
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Table 1-a. Absorption and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorption before exposition |
0.1561 |
0.1562 |
0.1497 |
Absorption after exposition |
0.2539 |
0.2604 |
0.2306 |
Opacity before exposition |
1.4325 |
1.4328 |
1.4116 |
Opacity after exposition |
1.7943 |
1.8214 |
1.7006 |
Opacity Difference |
0.3618 |
0.3885 |
0.2890 |
Mean opacity difference of the negative control is 0.3465
Table 1-b. Absorption and Opacity Values Test Item and Negative Control
Parameter |
Test Item peptone casein |
Positive Control |
||||
Absorption before exposition |
0.1235 |
0.1466 |
0.2209 |
0.1564 |
0.1368 |
0.1905 |
Absorption after exposition |
0.1634 |
0.1943 |
0.2778 |
1.9956 |
1.9713 |
1.7888 |
Opacity before exposition |
1.3289 |
1.4015 |
1.6630 |
1.4335 |
1.3703 |
1.5506 |
Opacity after exposition |
1.4568 |
1.5642 |
1.8958 |
98.9920 |
93.6052 |
61.4894 |
Opacity Difference |
0.1279 |
0.1627 |
0.2328 |
97.5585 |
92.2350 |
59.9388 |
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:
Table 1-c. Optical density at 490 nm
Repl. |
Negative Control |
Test Item peptone casein |
Positive Control |
Measured |
-0.0051 -0.0096 -0.0095 |
-0.0135 -0.0132 -0.0147 |
0.7970 0.6769 0.7647 |
Corrected |
-0.0255 -0.0480 -0.0475 |
-0.0675 -0.0660 -0.0735 |
3.9850 3.3845 3.8235 |
Mean |
-0.0403 |
-- |
IVIS was then calculated using the values in tables 1-a, 1-b and 1-c and the following equation: IVIS = (opacity difference - mean opacity difference of the negative controls) + [15 x (corrected OD490 - mean corrected OD490 of the negative controls)].
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table 2: IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control 0.9% NaCI |
-0.021 |
-0.259 |
-81.5% |
-0.331 |
|||
-0.423 |
|||
Test Item |
-0.627 |
-0.603 |
-4.9% |
-0.569 |
|||
-0.612 |
|||
Positive Control 10% NaOH |
157.591 |
139.467 |
14.5% |
143.260 |
|||
117.549 |
According to OECD Guideline no.437(2009), a substance that induces an IVIS >= 55.1 is defined as a corrosive or severe irritant. Substances with IVIS < 55.1 may be considered as non corrosive resp. not severely irritant.
ln the negative control, no signs of eye irritation were observed. The positive control showed very severe eye irritation. The test item peptone casein showed no severe eye irritation (values lay below negative control).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A mean IVIS of - 0.603 was calculated for peptone casein. According to ICCVAM classification and to OECD Guideline no. 437 (2009), the substance is not eye irritant.
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