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EC number: 920-338-0 | CAS number: 109236-76-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP-Study with no deficiencies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- docosyl 4-hydroxybenzoate
- EC Number:
- 920-338-0
- Cas Number:
- 109236-76-2
- Molecular formula:
- C29 H50 O3
- IUPAC Name:
- docosyl 4-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals: Healthy New Zealand White Rabbits Hsdlf: NZW, body weight at the beginning of the study > 2 kg.
Source: Harlan Winkelmann GmbH, D-33178 Borchen
Three female animals were used. The animals were derived from a controlled full barrier maintained breeding system (SPF).
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Animal Husbandry:
Semi-barrier in an air conditioned room
- Temperature: 18 ± 3°C (recommendations of TVT, GV-SOLAS; see References)
- Relative humidity: 55 + 10%
- Artificial light, sequence being 12 hours light, 12 hours dark Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days)
Preparation of the Animals:
Approximately 24 hours before the test, fur from animal no. 1 was removed from the dorsal area of the trunk by clipping. Approximately 23.5 hours before the test, for from animals no. 2 and 3 was removed from the dorsal area of the trunk by clipping.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The untreated flank of the animals.
- Amount / concentration applied:
- The test item was applied as a single dose to a small area (approx. 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.
- Duration of treatment / exposure:
- Test item was held in contact with the skin throughout a 4-hour period. The test item moistened with aqua ad inject.
- Observation period:
- The animals were examined for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours.
There were no significant body weight changes during the contact and observation period. The Primary Irritation Index (PII) was 0.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item 4-Hydroxybenzoic acid behenylester showed no irritant/corrosive effects. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) and the GHS (Globally Harmonised System of Classification and Labelling of Chemicals) the test item 4-Hydroxybenzoic acid behenylester does not have to be classified and has no obligatory labelling requirement for skin irritation.
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