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EC number: 226-107-4 | CAS number: 5280-80-8
- 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
Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405, OECD 437, OECD 492)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- (no informations if untreated skin served as control).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- yes
- Remarks:
- (no informations if untreated skin was used as control)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- commercial grade
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410-2530 g
- Housing: Individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with water before application
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The gauze patch with the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, Brugg / Switzerland).
REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted
SCORING SYSTEM: according to OECD 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 - 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- Due to intensive staining by the test compound scoring after 1 h was not possible. Erythema (score 1) were detected 24 h after treatment in 2 animals. One animal recovered within the next 24 h, whereas the other animal still showed erythema (score 2). This animal recovered 72 h after treatment. No edema were observed.
- Other effects:
- The body weight development was not affected by the application of the test article.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present experiment the test substance was found to be non-irritant and not corrosive when applied to the rabbit skin.
- Executive summary:
In a primary dermal irritation study (OECD 404, Ciba-Geigy Ltd., 1983), 3 female New Zealand White rabbits were dermally exposed to 0.5 g of the test substance for 4 hours under semiocclusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 0.44 and for edema was 0. The skin reactions observed were fully reversible within 48 hours. Under the conditions of the present experiment the test substance was found to be non-irritant and not corrosive when applied to the rabbit skin.
Reference
Table 1: Scoring of erythema and edema formation
Exposition: | 4 h, semiocclusive | ||
Animal | Reading | Erythema | Edema |
1 | 1 h | na | 0 |
2 | 1 h | na | 0 |
3 | 1 h | na | 0 |
1 | 24 h | 1 | 0 |
2 | 24 h | 0 | 0 |
3 | 24 h | 1 | 0 |
1 | 48 h | 0 | 0 |
2 | 48 h | 0 | 0 |
3 | 48 h | 2 | 0 |
1 | 72 h | 0 | 0 |
2 | 72 h | 0 | 0 |
3 | 72 h | 0 | 0 |
1 | 7 d | 0 | 0 |
2 | 7 d | 0 | 0 |
3 | 7 d | 0 | 0 |
1 | 24/48/72 hrs | 0.3 | 0 |
2 | 24/48/72 hrs | 0 | 0 |
3 | 24/48/72 hrs | 1 | 0 |
mean | 24 - 72 h | 0.44 | 0.00 |
na = not assessable due to staining produced by the test item.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- commercial grade
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410 - 2660 g
- Housing: individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: 5 days (23 June, 1983 - 27 June, 1983)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- see observation period (no washing conducted)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to OECD 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1 -3)
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 - 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 - 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 - 72 h
- Other effects:
- The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present experiment the test substance was found to be slightly irritant and not corrosive when applied to the rabbit eye mucosa.
- Executive summary:
An eye irritation test was performed with three male New Zealand White rabbits acc. to OECD 405 (Ciba-Geigy Ltd., 1983). Eyes were left unwashed after application of 0.1 g of test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0.1, 0, 0.1, and 0, respectively. After 48 hours all reactions were reversed. Under the conditions of the present experiment the test substance was found to be slightly irritant and not corrosive when applied to the rabbit eye mucosa. There was a clear tendency of recovery towards the end of the observation period and no classification according to EU- or EU-GHS-requirements is necessary.
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- commercial grade
Puriity>99% - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL bulk volume (about 9 mg) of the test substance - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used: Two EpiOcular™ tissue samples were pre-treated with 20 μL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes. Thereafter the tissues were treated with ca. 50 μL bulk volume (about 9 mg) of the test substance for 6 hours followed by a 18-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTI) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability.
- Positive and negative control means and acceptance ranges based on historical data: Yes - Irritation parameter:
- other: Mean tissue viability
- Run / experiment:
- tissue 1
- Value:
- 87
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: for details see table 2 in section "Any other information on results incl. tables"
- Irritation parameter:
- other: Mean tissue viability [% of NC]
- Run / experiment:
- tissue 2
- Value:
- 95.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: for details see table 2 in section "Any other information on results incl. tables"
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded that the test substance does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
- 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
- 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)
- Version / remarks:
- July 2013
- 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
- Specific details on test material used for the study:
- commercial grade
purity > 99% - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: A bulk volume of about 45 mg of the solid test substance was applied - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- METHOD:
The test method consists of a topical exposure of the test substance to the epithelial surface of isolated corneas from the eyes of freshly slaughtered cattle. Corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro lrritancy Score (IVIS) of the test substance, which is used for the prediction of serious eye damage.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Yes, De-ionized water
POSITIVE CONTROL USED: 20% imidazole in de-ionized water
APPLICATION DOSE AND EXPOSURE TIME: Three corneas were treated with the test substance for an exposure period of 4 hours. Because it was not possible to prepare a homogeneous 20% test substance preparation in water, the test substance was applied undiluted. For covering the whole surface of the cornea, a bulk volume of about 45 mg of the solid test substance was applied.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Measured quantitatively as the amount of light transmission through the cornea.
- Corneal permeability: Measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Decision criteria as indicated in the OECD guideline were used (see table 1 in section "Any other information on materials and methods incl. tables") - Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS, mean)
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Applying the citreria of the OECD 437 for the assessment of the BCOP test results, the IVIS score of the test substance of 0.0 does not support to classify the substance as causing eye irritation or serious eye damage.
Referenceopen allclose all
Table 1: Evaluation of the eye reactions
Animal | Reading | Cornea Opacity | Iris | Conjunctiva | |
Redness | Chemosis | ||||
1 | 1 h | 0 | 0 | 0 | 0 |
2 | 1 h | 1 | 0 | 1 | 0 |
3 | 1 h | 1 | 0 | 2 | 1 |
1 | 24 hrs | 0 | 0 | 0 | 1 |
2 | 24 hrs | 0 | 0 | 0 | 0 |
3 | 24 hrs | 1 | 0 | 1 | 1 |
1 | 48 hrs | 0 | 0 | 0 | 0 |
2 | 48 hrs | 0 | 0 | 0 | 0 |
3 | 48 hrs | 0 | 0 | 0 | 1 |
1 | 72 hrs | 0 | 0 | 0 | 0 |
2 | 72 hrs | 0 | 0 | 0 | 0 |
3 | 72 hrs | 0 | 0 | 0 | 0 |
1 | 7 days | 0 | 0 | 0 | 0 |
2 | 7 days | 0 | 0 | 0 | 0 |
3 | 7 days | 0 | 0 | 0 | 0 |
1 | 24/48/72 hrs | 0 | 0 | 0 | 0.3 |
2 | 24/48/72 hrs | 0 | 0 | 0 | 0 |
3 | 24/48/72 hrs | 0.3 | 0 | 0.3 | 0.7 |
mean animal 1-3 | 24/48/72 hrs | 0.1 | 0.0 | 0.1 | 0.3 |
Table 2: Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Test substance |
|
Tissue 1 |
Tissue 2 |
Mean |
Inter-tissue variability [%] |
NC |
Mean OD570 |
1.774 |
1.678 |
1.726 |
|
Viability [% of NC] |
102.8 |
97.2 |
100.0 |
5.6 |
|
CAS 5280-80-8 |
Mean OD570 |
1.502 |
1.647 |
1.574 |
|
Viability [% of NC] |
87.0 |
95.4 |
91.2 |
8.4 |
|
PC |
Mean OD570 |
0.379 |
0.414 |
0.396 |
|
Viability [% of NC] |
21.9 |
24.0 |
22.9 |
2.0 |
NC = Negative Control
PC = Positive Control
OD570 = Optical Density [wavelength 570 nm]
Table 2: Opacity score of the test substance, NC and PC
Test substance |
Cornea- No. |
Initial opacity |
Final opacity |
Opacity Change |
Corrected Opacity Change* |
Mean |
SD |
CAS 5280-80-8 |
13 14 15 |
2.7 2.5 2.2 |
3.9 1.9 3.3 |
1.2 -0.6 1.1 |
0.0 0.0 0.0 |
0.0 |
0.0 |
NC |
1 2 3 |
2.5 2.8 3.7 |
14.2 5.3 13.9 |
11.7 2.5 10.2 |
NA NA NA |
8.1 |
4.9 |
PC |
4 5 6 |
2.8 1.8 2.2 |
101.2 98.2 80.5 |
98.5 96.4 78.3 |
90.4 88.3 70.2 |
82.9 |
11.1 |
*Negative values are set to zero for further calculation
Table 3: Permeability score of the test substance, NC and PC
Test substance |
Cornea-No. |
Mean OD490 |
Dilution Factor |
Mean Corrected OD490 |
Mean |
SD |
CAS 5280-80-8 |
13 14 15 |
0.007 0.009 0.007 |
1 1 1 |
0.001 0.003 0.001 |
0.002 |
0.001 |
NC |
1 2 3 |
0.004 0.007 0.007 |
1 1 1 |
NA NA NA |
0.006 |
0.002 |
PC |
4 5 6 |
1.408 1.086 1.428 |
1 1 1 |
1.402 1.080 1.422 |
1.301 |
0.192 |
Table 4: In Vitro score (IVIS) of the test substance, NC and PC
Test substance |
Cornea-No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
mean |
SD |
|||||
CAS 5280-80-8 |
13 14 15 |
0.0 0.0 0.0 |
0.001 0.003 0.001 |
0.0 0.0 0.0 |
0.0 |
0.0 |
NC |
1 2 3 |
11.7 2.5 10.2 |
0.004 0.007 0.007 |
11.7 2.6 10.3 |
8.2 |
4.9 |
PC |
4 5 6 |
90.4 88.3 70.2 |
1.402 1.080 1.422 |
111.4 104.5 91.5 |
102.4 |
10.1 |
NA = not applicable; SD = standard derivation; OD490= optical density at 490 nano meter
Table 5: Histopathological findings of the test substance, NC and PC
Test substance |
Cornea-No. |
Histological evaluation |
|
finding |
score |
||
CAS 5280-80-8 |
13 14 15 |
no findings no findings no findings |
0 0 0 |
NC |
1 2 3 |
no findings no findings no findings |
0 0 0 |
PC |
4 5 6 |
Severe Severe severe |
IV IV IV |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
Reliable data from two studies on
skin irritation are available for the test substance. These data
reveal a very low skin irritation potential for the 'yellow disazo
condensation pigment'.
In a primary dermal OECD guideline irritation study (OECD 404,
Ciba-Geigy Ltd., 1983), 3 female New Zealand White rabbits were
dermally exposed to 0.5 g of the test substance (CAS 5280-80-8) for 4
hours under semiocclusive conditions. Animals then were observed for 7
days. Irritation was scored by the method of Draize as described in
the OECD guideline 404. The mean score for the 24, 48 and 72 h reading
for erythema was 0.44 and for edema was 0. The skin reactions observed
were fully reversible within 48 hours. Under the conditions of the
present experiment the test substance was found to be non-irritant and
not corrosive when applied to the rabbit skin (BASF, 1983).
In a supporting study 3 male and 3 female New Zealand White rabbits were
dermally exposed to 0.5 g of the test substance for 24 h under
occlusive conditions. After 24 and 72 hours the application sites were
assessed for oedema and erythema. Under the conditions of this test,
the pigment was also not considered to be irritating to the rabbit
skin (Ciba-Geigy Ltd., 1975).
Eye:
Reliable data from two in vitro and two in vivo studies on eye
irritation are available for the test substance.
For the test substance a Bovine Corneal Opacity and Permeability Test
(BCOP Test) according to OECD guideline 437 were conducted (BASF,
2015). Three corneas were treated with the undiluted test substance
(bulk volume of about 45 mg) for an exposure period of 4 hours. Based
on the observed results (IVIS score = 0.0) it was concluded, that the
test substance does not cause ocular corrosion or severe irritation in
the Bovine Corneal Opacity and Permeability Test (BCOP Test). However,
the Guideline also states, that due to limited accuracy of the BCOP
test to correctly identify substances that do not require
classification for eye irritation or serious eye damage, this test
method should not be the first choice to initiate a bottom-up
approach. Thus, the substance was also examined in an EpiOcular to
exclude an eye irritation potential.
The conducted EpiOcular™ Eye irritation study with the test substance
was performed according to OECD guideline 492 (BASF, 2015). The tissue
was treated with 50 µL bulk volume (about 9 g) of the test substance
for 6 hours followed by a 18-hours post-incubation period. The
determined mean relative tissue viability compared to the negative
control is 91.2 %. Since the mean tissue viability was >60 % of the
negative control, the test substance does not show any eye irritation
potential in the EpiOcular™ eye irritation test.
Further, two in vivo eye irritation test with New Zealand White rabbits
according to OECD 405 are available. In one test (Ciba-Geigy Ltd.,
1983) the eyes were left unwashed after application of 0.1 g of test
substance and the animals were observed 7 days. The mean scores for
the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea
opacity and conjunctivae chemosis were 0.1, 0, 0.1, and 0,
respectively. After 48 hours all reactions were reversed. In the other
test (Ciba-Geigy Ltd., 1975) three animals eyes were left unwashed and
three animals the eyes were washed out after 30 seconds after
application of 0.1 g of test substance and the animals were observed
72 hours. The mean scores for the 24, 48 and 72 h reading for
conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis
were 0 at any reading time point. Conjunctival redness was only
observed after 1 hour after application.
Based on the results of the in vitro and in vivo tests with the test substance it is concluded that the pigment is not irritating to the eye.
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 on skin irritation/corrosion and eye irritation, the
test item is not classified according to Regulation (EC) No 1272/2008
(CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.

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