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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-01-20 to 2009-02-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to OECD guideline 429 under GLP
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- Principles of method if other than guideline:
- Deviations from the study plan: for few hours the rel. humidity rose to 88% but returned and remained at acceptable levels for the remaining whole test duration
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- p-Hydroxybenzoesäure
- IUPAC Name:
- p-Hydroxybenzoesäure
- Details on test material:
- name of test item: p-Hydroxybenzoesäure
Sponsors Batch No.: 08/1000/10,1-20
production date: 20.10.2008
purity: 99,94%
storage: protected from light and moisture at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst, Netherlands
Strain: CBA/CaOlaHsd,
The female mice were housed in single cages under conventional conditions with 12h light/12 h dark at 19°C-25°C.
The female mice were 8-12 weeks old, nulliparous and non-pregnant and did not show any signs of illness. Acclimatisation was done minimum
5 days prior testing. Mice were weighed prior testing and prior administration of 3HTdR
- Weight at study initiation: 17.7 - 21.8 g (min - max)
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Humidity (%): 30 - 88 % (Deviations from the study plan: for few hours the rel. humidity rose to 88% but returned and remained at acceptable levels for the remaining whole test duration) In GL is stated: Humidity should preferably not exceed 70%.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5%, 10%, 25% (w/v) test substance in DMSO
Test item preparation: The test item was placed into a volumetric flask on a tared balance and dimethylsulfoxide was quantitatively added. - No. of animals per dose:
- 4 animals
- Details on study design:
- Pretests:
1. solubility experiment: highest test item concentration: 25% solution in dimethylsulfoxide after warming to 37°C.
2. to determine the highest non irritant test concentration:
- 2 animals were treated with 10 and 25% each on three consecutive days.
- animals showed no signs of irritation or systemic toxicity (observation: within 1 hour, and 24 hours +/-4 hours after each application)
Main study:
Three test groups and one vehicle control group of female mice were used. Four females per group.
p-Hydroxybenzoic acid in DMSO was applied to both dorsal ear lobes (left and right) (8mm) epidermal, topically in an amount of 25 microlitres.
Five days after the first topical application, the mice were injected intravenously into a tail vein with radio labelled thymidine
(3H-methyl-thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised
and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed with phosphate buffered saline and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl-thymidine measured in a beta-scintillation counter.
Observations during main study:
- mortality and viability: once daily on week days. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations were calculated for the body weight.
Results on LLNA are data on the pooled test groups.
Results and discussion
- Positive control results:
- 5% ; 10%; 25% (w/v) Hexylcinnamaldehyde in acetone/olive oil (4/1) abbreviated 5%, 10%, 25% HCA in the following table;
SI: stimulation index is defined as the DPM per lymph node of test group devided by the DPM of a control
5% HCA: SI = 1.49
10% HCA: SI = 4.17
25% HCA: SI = 4.90
for an IS of 3 an estimated concentration of 7.8% was calculated (see OECD 429)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks on result:
- other: 5% pHBA: SI = 0.94 10% pHBA: SI = 0.75 25% pHBA: SI = 0.99
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: control: DPM: 761 5% pHBA: 712 10% pHBA: 571 25% pHBA: 754 background: (BG1 and BG2 both 1 ml 5% Trichloracetic acid BG1: 31 and BG2: 122 control: 761
Any other information on results incl. tables
The EC3 value could not be calculated, since all SIs were below 3.
The EC3 value is defined as the concentration that causes a threefold increase in DPM compared to control and is a threshold concentration for skin sensitisation.
Body weight of tested animals and control animals showed no significant differences nor did body weights prior and after the testing period. No clinical symptoms were observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- p-Hydroxybenzoic acid was not sensitising the skin in this assay.
- Executive summary:
p-Hydroxybenzoic acid was tested in three concentrations (5%, 10%, 25%) in DMSO in the local lymph node assay with young female mice (strain CBA/CaOlaHsd) according to OECD guideline 429. Prior testing two animals were tested for irritation potential of p-HBA at doses of 10% and 25%, which was negative. 25% solution in DMSO is the technically highest possible concentration.
At all tested doses, no signs of skin sensitization based on DPM measurements per lymph node could be observed. There were no clinical symptoms at the ears nor mortality observed during the study period.
Tests, positive and negative controls were all valid.
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