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EC number: 203-265-2 | CAS number: 105-05-5
- 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
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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:
- other: Acceptable, non validated in vitro test, GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM-Recommended Test Method Protocol: Hen's Egg Test - Chlorioallantoic Membrane (HET-CAM) Test method, published 2010
- Deviations:
- yes
- Remarks:
- minor
- Principles of method if other than guideline:
- The basis of the method is to assess the eye irritancy potential of substances by means of the chorioallantoic membrane of hens' eggs (HET_CAM).
The study was carried out according to : ICCVAM-Recommended Test Method Protocol: Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM) Test Method, published 2010.
This method is increasingly used for the detection of eye mucosa membrane irritants. Eye irritation caused by external contact with chemical substances is characterized by corneal damage and/or conjunctival injury and/or iris defects.
The CAM of fertile eggs incubated for 9 days is a vital vascular membrane with a blood vessel complex. Effects which might produce irritancy in the conjunctiva are assessed by exposing the CAM to liquid or solid test items. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-diethylbenzene
- EC Number:
- 203-265-2
- EC Name:
- 1,4-diethylbenzene
- Cas Number:
- 105-05-5
- Molecular formula:
- C10H14
- IUPAC Name:
- 1,4-diethylbenzene
- Test material form:
- other: liquid
- Details on test material:
- purity: 99.3% (GC Method MS409A.M-Results)
Constituent 1
Test animals / tissue source
- Species:
- other: Chicken eggs
- Strain:
- other: Fertile white Leghorn chicken eggs
- Details on test animals or tissues and environmental conditions:
- Weight: 48-51g (according to Study Plan the weight should be 50-60 g)
Age: 7 days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 300 µL/egg (used undiluted)
- Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- 300 seconds
- Number of animals or in vitro replicates:
- 3 eggs treated with the test item
Negative control item 3 eggs treated with physiological saline
Positive control items 3 eggs treated with NaOH (0.1 N); 3 eggs treated with SDS (1%)
The solutions were prepared on the day of testing. - Details on study design:
- The weight of the eggs ranged from 48 to 60 g and not from 50 to 60 g as stated in the Study Plan.
This minor deviation did not affect the validity and integrity of the scientific results obtained during this study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 10.1
- Remarks on result:
- other: 1,4-diethylbenzene
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 0
- Remarks on result:
- other: Negative control 0.9% Na Cl solution
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 18.6
- Remarks on result:
- other: Positive control: 0.1N NaOH
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 10.2
- Remarks on result:
- other: Positive control: 1% aqueous solution sodium dodecil sulphate
- Irritant / corrosive response data:
- 20 seconds after application the CAM was carefully rinsed with 0.9% NaCl solution. The reactions on the CAM were observed over a period of 300 seconds. The time for the appearance of each of the noted endpoints was monitored and recorded, in seconds.
The following endpoints were observed:
- haemorrhage (bleeding from the vessels)
- vascular lysis (blood vessel disintegration)
- coagulation (intra- and extra-vascular protein denaturation)
Whereby,
Haemorrhage time = observed start (in seconds) of haemorrhage reactions on CAM
Lysis time = observed start (in seconds) of vessel lysis on CAM
Coagulation time = observed start (in seconds) of coagulation formation on CAM.
The evaluation consists in to giving scores of each to the three HET-CAM points at the three points 0.5, 2 and 5 minutes.
The numerical time-dependent scores for lysis, haemorrage and coagulation are summed to give a single numercial value indicating the potential of the test substance on a scale with a maximum value of 21. The mean value of three eggs facilitates an assessment by a classification scheme analogous to the Draize categories.
Any other information on results incl. tables
Table 1. Scoring scheme for irritation testing
Effect | score (0.5min) | score (2min) | score (5min) |
lysis | 5 | 3 | 1 |
haemorrage | 7 | 5 | 3 |
coagulation | 9 | 7 | 5 |
The observed effects were grades for each egg by an irritation score (IS) according to a formula
Table 2: IS Classificatio Scheme
IS score range | Irritation Assessment |
0 -0.9 | Practically none |
1 -4.9 | Slight |
5 -8.9 | Moderate |
9 -21 | Strong |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions 1,4-diethylbenzene was a strong irritant in an experiment employing the chorioallantoic membrane of hens' eggs (HET-CAM) as model.
- Executive summary:
The purpose of this study was to determine the eye irritancy potential of 1,4-Diethylbenzene by means of the chorioallantoic membrane of hens' eggs (HET-CAM). Eye irritation caused by external contact with chemical substances is characterized by corneal damage and/or conjunctival injury and/or iris defects.
The of fertile eggs incubated for 9 days is a vital vascular membrane with a blood vessel complex.
Three eggs each were treated with 300 µL1,4-Diethylbenzene/egg and with the control items. 0.9% NaCl solution was used as the negative control item. 0.1 NSodium hydroxide (NaOH)and 1% aqueous sodium dodecyl sulphate (SDS) were used as the positive control items. The administration volume for the control items was 300 µL per egg.
After administration of the test item blood vessels including the capillary system and the albumen were examined and scored for irritant effects (haemorrhage, coagulation and lysis) during 5 minutes.
The eggs treated with1,4-Diethylbenzene revealed an effect with an irritation score (IS) of 10.0. The test item was considered to be a strong irritant.
The positive control items 0.1or 1% SDS caused the expected effect with irritation scores (IS) of 18.6 or 10.0, respectively and, hence, were well within the historical data-range. No effects were observed in the negative control 0.9% NaCl solution. Hence,the HET-CAM assay is considered to be valid.
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