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Diss Factsheets
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EC number: 220-635-9 | CAS number: 2840-28-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, only limited data on test substance and animals or environmental conditions available, substance preparation and analysis not described
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- standard protocol described previously by Kimber and Basketter, 1992
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- para-aminobenzoic acid
- IUPAC Name:
- para-aminobenzoic acid
- Reference substance name:
- 4-aminobenzoic acid
- EC Number:
- 205-753-0
- EC Name:
- 4-aminobenzoic acid
- Cas Number:
- 150-13-0
- IUPAC Name:
- 4-aminobenzoic acid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/Ca (Laboratories A and B; Harlan Olac, Bicester, Oxfordshire, UK) or female CBA/JHsd mice (Laboratories C, D and E; Harlan Sprague Dawley, Inc., Frederick, MD, USA)
6-12 weeks old
housed under standard conditions
Food and tap water were available ad libitum.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 1, 2.5, 5, 10%
- No. of animals per dose:
- 4-5
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice (n = 4 or 5) were treated by topical application with 25 microliter of various concentrations of the test material or with vehicle alone on the dorsum of both ears. Treatments were performed daily for three consecutive days and then the mice were rested for 2 days prior to analysis.
On the sixth day, the mice were injected intravenously via the tail vein with 250 microliter of phosphate buffered saline (PBS) containing 20 microCi of tritiated methyl thymidine ( 3H-TdR; specific activity 2 Ci/mmol; Amersham International, Amersham, Bucks, UK).
Five h later mice were sacrificed and the draining auricular lymph nodes excised and pooled for each experimental group. Single cell suspensions of LNC were prepared by gentle mechanical disaggregation through 200-mesh stainless steel gauze. Pooled LNC were washed twice with an excess of PBS and precipitated with 5% trichloroacetic acid (TCA) at 4°C. Approximately 12 h later the samples were pelleted by centrifugation, resuspended in 1 ml 5% TCA and transferred to 10 ml of scintillation fluid (Optiphase MP, LKB Scintillation Products, FSA Laboratory Supplies, UK).
Incorporation of 3HTdR was measured by gamma-scintillation counting and expressed as disintegrations per minute (dpm) per node by dividing the total dpm per group by the number of nodes.
Stimulation indices (SI) for each experimental group were determined as the increase in 3H-TdR incorporation relative to vehicle-treated controls.
In three of five laboratories modiefied tests were performed:
4 days treatment, no pooling or
[125-iododeoxyuridine instead of thymidine and no pooling - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- In Laboratories C, D and E, in which isotope incorporation was determined for individual mice, a mean dpm value f S.E. was calculated for each experimental group. A stimulation index was derived for each experimental group by dividing the mean dpm of the experimental group by the mean dpm of the vehicle control group. For statistical analyses, the mean dpm values for each test chemical concentration treatment group were initially normalized by obtaining their log value. Bartlett’s test (Bartlett, 1937) was then used to examine the data for homogeneity of the within-chemical treatment variance. When analysis of variance revealed significant differences in parametric data, experimental groups were compared with vehicle-treated controls using Dunnett’s t test (Dunnett, 1955).
For non-parametric data, a Kruskal-Wallis test (Kruskal and Wallis, 1952) followed by Dunn’s multiple comparison procedure (Dunn, 1964) was used. Groups differing from vehicle-treated controls at the level of P I 0.01 were considered significant. Jonckheere’s trend analysis (Gross and Clark, 1975) was used to test for dose-dependent effects at a significance level of P I 0.01.
Stimulation indices from each of the live participating Laboratories were compared by analysis of covariance separately for each chemical. Differences in overall stimulation indices obtained and in the relationship between stimulation indices and dose amongst the participating Laboratories were evaluated. Estimates of the test material concentration required to produce a stimulation index of 3 were calculated for DNCB, HCA, oxazolone, isoeugenol, eugenol and SLS using fitted quadratic regression analyses.
Results and discussion
- Positive control results:
- 3-fold or greater increase in the proliferative activity of draining lymph node cells compared with vehicle-treated controls
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Exposure Zeneca (A) Unilever (B) Procter & Gamble (C) IITRI (D) DuPont (E) concentration % vehicle 0.5 0.9 1.2 1.1 1.6 1.1 1 1.0 1.2 1.1 0.8 0.6 2.5 1.4 1.1 1.2 0.9 0.7 5 1.1 1.6 1.1 0.7 0.8 10 1.0 1.4 1.0 0.7 0.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Exposure Zeneca (A) Unilever (B) Procter & Gamble (C) IITRI (D) DuPont (E) concentration % vehicle 453 438 90 139 59 0.5 399 546 101 223 67 1 457 536 98 116 37 2.5 626 486 104 121 39 5 519 682 100 91 46 10 452 593 86 97 35
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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