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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-11-18 to 2009-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- dated 24th April, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- of Council regulation No. 440/2008
- Deviations:
- no
- 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 of test material: p-Hydroxybenzoesäure
CAS No.: 99-96-7
Sponsors Batch No.: 08/1000/10,1-20
production date: 20.10.2008
purity: 99,94%
colour: white
form: powder
storage: protected from light and moisture at room temperature
expiry date: October 2011
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- -three female rabbits, 12-13 weeks old, weight during the test: 2.54-2.94 kg
-the animals were kept for a minimum of five days for an acclimatisation period
-each animal was kept in an individual box at 17-23 °C, lighting was 12h continuous light and 12 h continuous dark,
relative hunidity ranged from 30-70%
-animals had free access to drinking water and food
-rate of air exchange: ca. 15 changes / hour
-light/ dark ratio: 12 h/ 12 h
-weight of animals: (beforetest /after test):
animal 1: (2,69 kg/2,77kg)
animal 2: (2,54 kg/2,60kg)
animal 3: (2,79 kg/2,94kg)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened patch with water
- Controls:
- not required
- Amount / concentration applied:
- 0,5 g test substance (as supplied) was applied on the skin with a water moistened patch ca. 6 cm².
The patch was fixed with surgical tape. - Duration of treatment / exposure:
- The exposure remained for 4 hours on one shaved flank of the animal, the other flank served as control, without treatment.
After that the treated area was rinsed with distilled water. - Observation period:
- 1 hour, 24, 48, 72 hours after removal of the patch
- Number of animals:
- 3 female
- Details on study design:
- one animal was tested first, then two other animals were tested
one flank of the animal was tested, the other flank served as control
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- and eschar score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- >= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- erythema score
- Remarks:
- and eschar score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- and eschar score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- and eschar score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- >= 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Only one animal showed a very slight erythema after one hour, which was fully reversibel after 24h.
All other results on erythema, eschar and edema in all animals were at the score rate: zero - Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- according to EU classification, the item does not have to be classified
according to GHS classification, the item does not have to be classified - Executive summary:
0,5 g 5-HBA were applied to 6 cm² skin of three female New-Zealand White rabbits as test animals. Exposure was 4 hours with observations at 1, 24, 48, 72 hours post exposure. The study is valid and classified as reliable without restrictions.
The results showed short term mild irritation in one animal. The limits for classification were not surpassed. Concluding, p-Hydroxybenzoic acid does not have to be classified as skin irritant according to CLP classification criteria.
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