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EC number: 202-804-9 | CAS number: 99-96-7
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-12-03 to 2009-01-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD draft guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Draft guideline OECD 405 dated 2002-04-24
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-hydroxybenzoic acid
- EC Number:
- 202-804-9
- EC Name:
- 4-hydroxybenzoic acid
- Cas Number:
- 99-96-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 4-hydroxybenzoic acid
- Details on test material:
- Name: p-Hydroxybenzoesäure
composition: para-Hydroxybenzoic acid
Batch No.: 08/1000/10, 1-20
date of production: 2008-10-20
purity 99.94%, white powder
storage: 15°C-25 °C, dry and dark
date of expiry: 01.10.2011
Constituent 1
Test animals / tissue source
- Species:
- other: Lohmann selected Leghorn chicken's eggs
- Strain:
- other: Lohmann Leghorn
- Details on test animals or tissues and environmental conditions:
- Freshly laid Lohmann Leghorn chicken eggs
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany, arrived on 05th Dec. 2008, 9 days before the start of the test)
Eggs were incubated at 36.5°C-37.5°C for eight days,
During incubation eggs were rotated to prevent an attachment of the embryo to one side of the egg.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- no data
50% of the surface of the membrane were coverd with the test item. - Duration of treatment / exposure:
- 300 seconds
- Observation period (in vivo):
- 300 seconds
- Number of animals or in vitro replicates:
- 6 for the test substance
3 for negative control
3 for positive control 0.1% NaOH
3 for postive control 1% SDS - Details on study design:
- Negative control: physiological NaCl Solution
Positive controls:
- Sodium Dodecyl Sulfate Solution (C12H25NaO4S, CAS-No. 151-21-3, 10 g/L solution in deionised water)
- Sodium Hydroxide Solution 0.1 N (NaOH, CAS-No. 1310-73-2, dissolved in deionised water, 4 g/L)
Test vessels: made of glass or sterilizable plastic, sterilisation before use (either heating to 180°C for 2 hours, or autoclavation)
Preparation of the test system:
non-vialble eggs (observed by using a candle) were discarded 24 hours before the experiment (incubation)
Method description
After opening of the egg at the day of the test, the inner membrane was moistened with 0.9% NaCl, the egg was left to stand
in the incubator for 30 min and then the solution was decanted and the inner membrane was removed with foreceps.
Then the test substance was directly given to the CAM (chorio-allantoic-membrane) surface in such a manner, that approx.
50 % of the membrane was covered with the solid test substance.
The reactions on the CAM were observed for 300 seconds regarding the endpoints:
-haemmorrhage (bleeding of blood vessels)
-vascular lysis (blood vessel disintegration)
-coagulation (protein denaturation)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The test item p-Hydroxybenzoesäure was tested in the HET-CAM-Test according to Draft guideline OECD 405 dated 2002-04-24 with Lohmann Leghorn chicken eggs. Following an 8 day incubation period the CAM was exposed with the solid test item for 5 min and obs
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: according to the guideline used
- Conclusions:
- The negative controls showed no irritation, the positive controls showed severe irritations and the test item applied
as a solid showed no irritations. - Executive summary:
The test item p-Hydroxybenzoesäure was tested in the HET-CAM-Test according to Draft guideline OECD 405 dated 2002-04-24 with Lohmann Leghorn chicken eggs. Following an 8 day incubation period the CAM was exposed with the solid test item for 5 min and observed for 5 min.
The Irritating Score was 0.0 in all six replicates of the test item. Negative controls showed no irritating effects. The 2 positive controls induced severe irritation.
The test item p-Hydroxybenzoesäure under this experimental conditions of this study possesses no irritation potential. The non irritating results of this in-vitro test system are not sufficient for classification as not irritating according to EU-GHS (CLP-Regulation).
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