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EC number: 813-180-8 | CAS number: 5856-32-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Sep 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- - Principle of test: With the HET-CAM (Hen's Egg Test – Chorioallantoic Membrane) test (according to INVITTOX Protocol No. 47, https://ntp.niehs.nih.gov/iccvam/docs/protocols/ivocular-hetcam.pdf) an irritative or corrosive potential of the test substance can be determined by the detection of damages in blood vessels under the chorioallantoic membrane (CAM) of fertilized and incubated chicken eggs. The CAM is a vital vascular membrane with a closed blood vessel system. After application of a test item on the membrane the underlying blood vessels could become damaged.
- Short description of test conditions: Eggs were incubated at 37.5 ± 1 °C for eight days. During incubation the eggs were rotated to prevent an attachment of the embryo to one side of the egg. On day eight the eggs were candled (held in front of a strong lamp in order to determine the position of the chicken fetus) and non-viable eggs (eggs containing no fetus) were discarded. The remaining eggs were placed upwards in the incubator and incubated for another day without rotation. On day 9, the shell above the oxygen bubble was removed. The egg skin was removed from the membrane. The test substance was applied to the membrane and the incidence and severity of damage was recorded.
- Parameters analysed / observed: In particular three events are observed: haemorrhage, vessel lysis and coagulation of the blood in the vessels. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: Eggs from Lohmann Selected Leghorn chicken
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 76 to 77 mg
- Duration of treatment / exposure:
- 300 s
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION: Eggs were incubated at 37.5 ± 1 °C for eight days. During incubation the eggs were rotated to prevent an attachment of the embryo to one side of the egg. On day eight the eggs were candled (held in front of a strong lamp in order to determine the position of the chicken fetus) and non-viable eggs (eggs containing no fetus) were discarded. The remaining eggs were placed upwards in the incubator and incubated for another day without rotation. On day 9, the day of the performance of the experiment, the eggs were candled once again in order to determine the position of the egg's oxygen bubble. The position was marked on the eggshell. Along the marking the eggshell was sawed with an electric saw. Afterwards, the shell above the oxygen bubble was removed. The egg skin beneath was covered with saline in order to separate the egg skin from the chorioallantoic membrane beneath the skin. After a short incubation period at 37.5 ± 1 °C the egg skin was removed from the membrane easily using forceps.The test item was applied directly to the membrane in order to cover at least 50% of the membrane.
NUMBER OF REPLICATES: 3 eggs per group (treatment, negative control, positive control (NaOH), positive control (SDS)
NEGATIVE CONTROL USED: 300 µL of a 0.9% (w/v) NaCl solution in deionised water
POSITIVE CONTROL USED: 300 µL of a 1% SDS solution in deionised water; 300 µL of a 0.1 N NaOH solution in deionised water
APPLICATION DOSE AND EXPOSURE TIME: 76 to 77 mg undiluted test item; 300 s exposure period (concurrent observation period)
OBSERVATIONS: The membranes of the eggs were observed for 300 seconds. Lesions of the underlying blood vessels were monitored and noted. In particular three endpoints were observed and the time point at which an effect occurs was recorded. The three endpoints were haemorrhage, coagulation and lysis of the blood vessel.
EVALUATION OF RESULTS: A strong irritating effect shows very fast and strong lesions on the blood vessels underlying the membrane. A weak irritating effect shows very slow and weak reactions. Based on the time recorded for each endpoint an irritancy index (R) can be calculated as follows:
R = ((301-h) × 5)/300 + ((301-l) × 7)/300 + ((301-c) × 9)/300
h = time in seconds at which haemorrhages appear
l = time in seconds at which lysis occurs first
c = time in seconds at which coagulation of protein or blood was noticed first
The mean score for each experimental group was calculated from the individual scores of each egg. The score obtained enabled assessment of the irritancy potential of the test items as follows:
CAM Mean Irritancy Index
0 – 0.9: Not irritant
1 – 4.9: Slight irritant
5 – 8.9: Moderate irritant
9 – 21: Severe irritant
Results and discussion
In vitro
Results
- Irritation parameter:
- other: CAM Mean Irritancy Index
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes for NaOH and SDS
- Range of historical values: Irritancy index R [%]: Negative control: 0.00 ± 0.00 (0.9 % NaCl); Positive control: 19.14 ± 0.39 (0.1 N NaOH), 9.94 ± 0.76 (1 % SDS)
Any other information on results incl. tables
Table 1: Results with the test item and the controls
Test Group |
Time until Haemorrhage [s] |
Time until Lysis [s] |
Time until Coagulation [s] |
Irritancy Index R |
Mean Irritancy Index R |
Evaluation |
Negative Control |
301 |
301 |
301 |
0.00 |
0.00 |
not irritant |
301 |
301 |
301 |
0.00 |
|||
301 |
301 |
301 |
0.00 |
|||
Positive Control 0.1 N NaOH |
10 |
30 |
15 |
19.75 |
19.54 |
severe irritant |
12 |
39 |
18 |
19.42 |
|||
12 |
36 |
19 |
19.46 |
|||
Positive Control 1% SDS |
11 |
65 |
301 |
10.34 |
10.40 |
severe irritant |
13 |
54 |
301 |
10.56 |
|||
12 |
66 |
301 |
10.30 |
|||
Test Item |
301 |
301 |
301 |
0.00 |
0.00 |
not irritant |
301 |
301 |
301 |
0.00 |
|||
301 |
301 |
301 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- According to the ECHA Guidance on IR and CSA ´Chapter R.7a Endpoint specific guidance`(Version 4.1 October 2015), the HET-CAM test method may be used to classify a substance as Category 1 for serious eye damage. The test may not be used to determine the non-classification of a substance.
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