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EC number: 201-762-9 | CAS number: 87-66-1
- 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
Endpoint summary
Administrative data
Description of key information
Pyrogallol was identified as a skin sensitizer in experimental animal models and by QSAR prediction. Moreover, a number of human studies in individuals exposed to hairdressing chemicals showed that pyrogallol is a contact sensitizer and, according to Banca Dati Sensibilizzanti (ISS, Italy), Pyrogallol is a substance for which a (skin) sensitizing potential cannot be excluded.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM-recommended protocol
- Deviations:
- no
- Principles of method if other than guideline:
- The objective of this study was to determine the contact sensitization potential of pyrogallol (PYR) when applied dermally to female BALB/c mice. Measurement of the contact hypersensitivity response was initially accomplished using the local lymph node assay.
- GLP compliance:
- not specified
- Remarks:
- refer to section "any other information on materials and methods" for remarks related to GLP compliance for a test performed after 2008, 1st June.
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
purchased from Sigma (St. Louis, MO).
- Expiration date of the lot/batch:
not specified
- Purity test date: not specified
RADIOLABELLING INFORMATION (if applicable)
not applicable
- Radiochemical purity:
-
- Specific activity: -
- Locations of the label: -
- Expiration date of radiochemical substance:
-
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
not specified
- Stability under test conditions:
not specified
- Solubility and stability of the test substance in the solvent/vehicle:
Initial studies on the solubility of PYR demonstrated that the compound was soluble at concentrations of 75% (w/v) and below in acetone:olive oil
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
not specified
- Preliminary purification step (if any):
not specified
- Final dilution of a dissolved solid, stock liquid or gel:
Test solutions were prepared daily in the vehicle 4:1 acetone:olive oil (AOO) as recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; Dean et al., 2001).
- Final preparation of a solid:
not relevant
FORM AS APPLIED IN THE TEST (if different from that of starting material)
liquid
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable
OTHER SPECIFICS: white odorless crystal (FW 126.11, CAS No.87-66-1) - Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Female BALB/c mice were obtained from Charles River Laboratories
- Females (if applicable) nulliparous and non-pregnant:not specified
- Microbiological status of animals, when known: The mice were determined to be hepatitis and Sendai virus free by serology testing.
- Age at study initiation: 6–8 wks old
- Weight at study initiation: 17–20 grams
- Housing: Mice were housed four animals per cage in plastic shoebox cages with hardwood bedding
- Diet (e.g. ad libitum): Food (Harlan Teklad laboratory diets NIH-07) was provided ad libitum in all experiments
- Water (e.g. ad libitum): tap water was provided ad libitum in all experiments
- Acclimation period: The animals were quarantined for at least 7 days prior to being placed on study
- Indication of any skin lesions: Animals were observed for signs of moribundity daily, weighed on the first and last days of each
study, and euthanized by CO2 inhalation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21–24°C
- Humidity (%): 40–70% relative humidity
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle
- IN-LIFE DATES: From: To:
Other information: The BALB/c mouse is the National Toxicology Program (NTP) strain of choice for conducting contact hypersensitivity testing in rodents.- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- the highest exposure level of PYR selected for the LLNA was 50% in the first study (NIH, 1999; Dean et al., 2001).
Four additional exposure levels of PYR (2.5%, 5%, 10%, 25% and 50%).
The concentrations of PYR used in the second experiment were 0.5%, 1%, and 2.5%.
The concentrations of PYR used in the third experiment were 0.25%, 0.5%, 1%, 2.5%, 5%, and 10% - No. of animals per dose:
- eight mice were assigned for each dose group.
- Positive control substance(s):
- other: 1-fluoro-2,4-dinitrobenzene
- Statistics:
- The data obtained in this study were first tested for homogeneity of variances using Bartlett’s Chi Square Test. Homogeneous data were evaluated by a parametric one-way analysis of variance. When significant differences occurred, treatment groups were compared to the appropriate control using Dunnett’s Test. If data were non-homogeneous, they were evaluated using a non-parametric analysis of variance. When significant differences occurred, treatment groups were compared to the appropriate control using the Wilcoxon Rank Test.
The positive control was compared to the PCCO using the Student’s t Test. The level of statistical significance was set at p ≤ 0.05. All values are presented as mean ± standard error of mean. - Key result
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- dermal exposure to PYR produced a positive response in the LLNA at concentrations as low as 0.5%.
- Remarks on result:
- other: The SI SI was defined as the total DPM per mouse divided by vehicle DPM per mouse.
- Remarks:
- Disintegrations per minute (DPM) were calculated as (counts per minute (CPM) - background count)/(the efficiency of the Beta Counter, which was 71%).
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 2,5% dose group - first experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 5% dose group - first experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 10% dose group - first experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 25% dose group - first experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 50% dose group - first experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 1% dose group - second experiment
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- 0,5% dose group - third experiment
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 0,25% dose group - third experiment
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: first experiment: PYR induced a significant increase in the proliferation of lymph node cells (SI > 3) at all concentrations; All groups except 0.25% PYR exhibited a significant increase (SI > 3)
DETAILS ON STIMULATION INDEX CALCULATION not specified
EC3 CALCULATION : EC3 value between 0.5–1% after combining all three LLNAs
CLINICAL OBSERVATIONS: not specified
BODY WEIGHTS not specified - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The results demonstrate that PYR is both a sensitizer and an irritant in female BALB/c mice: dermal exposure to PYR produced a positive response in the LLNA at
concentrations as low as 0.5%. - Executive summary:
Hair dye components such as pyrogallol and cresol have been shown previously to promote allergic reactions such as rashes, dermal inflammation, irritation and dermatitis. The objective of this study was to determine the contact sensitization potential of pyrogallol (PYR) when applied dermally to female BALB/c mice. Measurement of the contact hypersensitivity response was initially accomplished using the local lymph node assay. For PYR, significant increases in the proliferation of lymph node cells were observed at concentrations of 0.5% (w/v) and higher. . Results from the irritancy assay suggested that PYR was an irritant. To further delineate whether PYR was primarily an irritant or a contact sensitizer, the mouse ear swelling test (MEST) was conducted. A significant increase in mouse ear thickness was observed at 72 hr following challenge with 0.5% PYR in mice that had been sensitized with 5% PYR. Additional studies examining lymph node subpopulations and CD86 (B7.2) expression by B cells further support the indication that PYR was a sensitizer in BALB/c mice. The results demonstrate that PYR is both a sensitizer and an irritant in female BALB/c mice.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Mouse Ear Swelling Test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: Gad et al., 1986; Auttachoat et al., 2011)
- Deviations:
- yes
- Remarks:
- with slight modifications.
- GLP compliance:
- not specified
- Remarks:
- refer to section "any other information on materials and methods" for remarks related to GLP compliance for a test performed after 2008, 1st June
- Type of study:
- other: Mouse Ear Swelling Test
- Justification for non-LLNA method:
- The potential for induction of hypersensitivity responses following treatment with PYR was (also) evaluated using the MEST.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
purchased from Sigma (St. Louis, MO).
- Expiration date of the lot/batch:
not specified
- Purity test date: not specified
RADIOLABELLING INFORMATION (if applicable)
not applicable
- Radiochemical purity:
-
- Specific activity: -
- Locations of the label: -
- Expiration date of radiochemical substance:
-
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
not specified
- Stability under test conditions:
not specified
- Solubility and stability of the test substance in the solvent/vehicle:
Initial studies on the solubility of PYR demonstrated that the compound was soluble at concentrations of 75% (w/v) and below in acetone:olive oil
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
not specified
- Preliminary purification step (if any):
not specified
- Final dilution of a dissolved solid, stock liquid or gel:
Test solutions were prepared daily in the vehicle 4:1 acetone:olive oil (AOO) as recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; Dean et al., 2001).
- Final preparation of a solid:
not relevant
FORM AS APPLIED IN THE TEST (if different from that of starting material)
liquid
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable
OTHER SPECIFICS: white odorless crystal (FW 126.11, CAS No.87-66-1) - Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Female BALB/c mice were obtained from Charles River Laboratories
- Females (if applicable) nulliparous and non-pregnant:not specified
- Microbiological status of animals, when known: The mice were determined to be hepatitis and Sendai virus free by serology testing.
- Age at study initiation: 6–8 wks old
- Weight at study initiation: 17–20 grams
- Housing: Mice were housed four animals per cage in plastic shoebox cages with hardwood bedding
- Diet (e.g. ad libitum): Food (Harlan Teklad laboratory diets NIH-07) was provided ad libitum in all experiments
- Water (e.g. ad libitum): tap water was provided ad libitum in all experiments
- Acclimation period: The animals were quarantined for at least 7 days prior to being placed on study
- Indication of any skin lesions: Animals were observed for signs of moribundity daily, weighed on the first and last days of each
study, and euthanized by CO2 inhalation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21–24°C
- Humidity (%): 40–70% relative humidity
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle
- IN-LIFE DATES: From: To:
Other information: The BALB/c mouse is the National Toxicology Program (NTP) strain of choice for conducting contact hypersensitivity testing in rodents.- Route:
- epicutaneous, open
- Vehicle:
- acetone/olive oil (4:l v/v)
- Concentration / amount:
- 50 μl of PYR
- Day(s)/duration:
- days 1, 2 and 3.
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, open
- Vehicle:
- acetone/olive oil (4:l v/v)
- Concentration / amount:
- total of 25 μl of Pyr or vehicle
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- not specified
- Details on study design:
- To further distinguish between the irritant and sensitizing effects of PYR, the MEST was conducted
- Challenge controls:
- vehicle
- Positive control substance(s):
- yes
- Positive control results:
- The positive control group also exhibited significantly increased percent ear swelling when compared to the PCCO group. No significant changes were observed at either 24 or 48 hr time point
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 17
- Total no. in group:
- 8
- Clinical observations:
- A significant increase in percent ear swelling was observed at 72 hr after challenge in mice that had been sensitized with 5% PYR when compared to VHIC
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The MEST suggested that PYR was indeed a sensitizer at higher concentrations.
PYR, elicited dermal sensitization in female BALB/c mice, as demonstrated using the the MEST. - Executive summary:
Hair dye components such as pyrogallol and cresol have been shown previously to promote allergic reactions such as rashes, dermal inflammation, irritation and dermatitis. The objective of this study was to determine the contact sensitization potential of pyrogallol (PYR) when applied dermally to female BALB/c mice. Measurement of the contact hypersensitivity response was initially accomplished using the local lymph node assay. For PYR, significant increases in the proliferation of lymph node cells were observed at concentrations of 0.5% (w/v) and higher. . Results from the irritancy assay suggested that PYR was an irritant. To further delineate whether PYR was primarily an irritant or a contact sensitizer, the mouse ear swelling test (MEST) was conducted. A significant increase in mouse ear thickness was observed at 72 hr following challenge with 0.5% PYR in mice that had been sensitized with 5% PYR. Additional studies examining lymph node subpopulations and CD86 (B7.2) expression by B cells further support the indication that PYR was a sensitizer in BALB/c mice. The results demonstrate that PYR is both a sensitizer and an irritant in female BALB/c mice.
- Endpoint:
- skin sensitisation, other
- Remarks:
- Immunofluorescent Staining of Lymph Node Cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test:
immunofluorescent staining consists of labeling anti-bodies with a fluorescent dye, allowing the labeled antibodies to react with their specific antigen, and observing the reaction product under the fluorescence microscope.
- Short description of test conditions: Mice were exposed to 0.125–10% pyrogallol using the same treatment regimen as the LLNA and were sacrificedat 24, 72 and 96 h after the last pyrogallol treatment.
- Parameters analysed / observed: %B cells, %T cells and the ratioof %B cells in treated animals to %B cells in vehicle control ani-mals (“%B ratio”), with a cutoff value of 1.25 separating irritants(%B ratio < 1.25) and sensitizers (%B ratio ≥ 1.25). Cells (1.0 × 10^6) were labeled in a 96-well culture plate with 0.10 ml of the appropriate anti-mouse monoclonal antibodiesdiluted in PBS (pH 7.4, 1% BSA + 0.1% sodium azide). A Anti-mouse CD3Ɛ (145-2C11) conjugated tofluorescein isothiocyanate (FITC; 1:80) was used to label T cells. B cells were stainedwith FITC conjugated affinity purified anti-mouse immunoglobulin (1:80, BectonDickenson) and phycoerythrin (PE) conjugated antibody for CD86 (B7.2). - GLP compliance:
- not specified
- Remarks:
- refer to section "any other information on materials and methods" for remarks related to GLP compliance for a test performed after 2008, 1st June
- Type of study:
- other: Immunofluorescent Staining of Lymph Node Cells
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: purchased from Sigma (St. Louis, MO).
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
RADIOLABELLING INFORMATION (if applicable) not applicable
- Radiochemical purity: -
- Specific activity: -
- Locations of the label: -
- Expiration date of radiochemical substance: -
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: Initial studies on the solubility of PYR demonstrated that the compound was soluble at concentrations of 75% (w/v) and below in acetone:olive oil
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: Test solutions were prepared daily in the vehicle 4:1 acetone:olive oil (AOO) as recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; Dean et al., 2001).
- Final preparation of a solid: not relevant
FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable
OTHER SPECIFICS: white odorless crystal (FW 126.11, CAS No.87-66-1) - Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Female BALB/c mice were obtained from Charles River Laboratories
- Females (if applicable) nulliparous and non-pregnant:not specified
- Microbiological status of animals, when known: The mice were determined to be hepatitis and Sendai virus free by serology testing.
- Age at study initiation: 6–8 wks old
- Weight at study initiation: 17–20 grams
- Housing: Mice were housed four animals per cage in plastic shoebox cages with hardwood bedding
- Diet (e.g. ad libitum): Food (Harlan Teklad laboratory diets NIH-07) was provided ad libitum in all experiments
- Water (e.g. ad libitum): tap water was provided ad libitum in all experiments
- Acclimation period: The animals were quarantined for at least 7 days prior to being placed on study
- Indication of any skin lesions: Animals were observed for signs of moribundity daily, weighed on the first and last days of each
study, and euthanized by CO2 inhalation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21–24°C
- Humidity (%): 40–70% relative humidity
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle
- IN-LIFE DATES: From: To:
Other information: The BALB/c mouse is the National Toxicology Program (NTP) strain of choice for conducting contact hypersensitivity testing in rodents.- Positive control results:
- no data
- Reading:
- other: mean fluorescence intensity
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- %B cells
- Reading:
- other: mean fluorescent intensity
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 6
- Total no. in group:
- 8
- Clinical observations:
- %T cells
- Reading:
- other: mean fluorescent intensity
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 8
- Clinical observations:
- %CD4+T cells
- Cellular proliferation data / Observations:
- not relevant
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Increases in auricular lymph node cellularity and in the percentage of B cells also support classifying PYR as a contact sensitizer.
- Executive summary:
Hair dye components such as pyrogallol and cresol have been shown previously to promote allergic reactions such as rashes, dermal inflammation, irritation and dermatitis. The objective of this study was to determine the contact sensitization potential of pyrogallol (PYR) when applied dermally to female BALB/c mice. Measurement of the contact hypersensitivity response was initially accomplished using the local lymph node assay. For PYR, significant increases in the proliferation of lymph node cells were observed at concentrations of 0.5% (w/v) and higher. Results from the irritancy assay suggested that PYR was an irritant. To further delineate whether PYR was primarily an irritant or a contact sensitizer, the mouse ear swelling test (MEST) was conducted. A significant increase in mouse ear thickness was observed at 72 hr following challenge with 0.5% PYR in mice that had been sensitized with 5% PYR. Additional studies examining lymph node subpopulations and CD86 (B7.2) expression by B cells further support the indication that PYR was a sensitizer in BALB/c mice. The results demonstrate that PYR is both a sensitizer and an irritant in female BALB/c mice.
Referenceopen allclose all
Based on the ICCVAM-recommended criteria, a chemical would be classified as positive if at least one concentration reached a stimulation index (SI) of ≥ 3 with the results being statistically significant and dose-responsive. The SI was defined as the total DPM (Disintegrations per minute) per mouse divided by vehicle DPM per mouse.
Vehicle (acetone: olive oil) | 11(%ear swelling) |
vehicle, irritancy control | 7(% ear swelling) |
mice that had been sensitized with PYR at 1% | 10(% ear swelling) |
mice that had been sensitized with PYR at 5% | 17(% ear swelling)* |
* ≤ 0.05 when compared to the vehicle, irritancy control |
Mice were exposed to 0.125–10% PYR using the same treatment regimen as the LLNA and were sacrificed at 24, 72 and 96 hrs after the last PYR treatment. 24 hrs after the last exposure to PYR, the %B ratios exceeded 1.25 for the 5% and 10% PYR treatment groups, when compared to the VH control group. Consistent with the increase in %B cells, %T cells were decreased at these same PYR treatment levels. CD86 (B7.2) is a selective marker for modulation of B cell activation, and its expression in murine draining lymph node cells has been demonstrated following sensitizer, but not irritant, treatment (Gerberick et al., 1999). A significant increase in the expression (the mean fluorescence intensity) of CD86 was observed for B cells at 5% and 10% PYR. This was accompanied by a significant increase in the number of total lymph node cells. Similar results were observed for the number of total lymph node cells, %B cells, %T cells, and CD86 expression by B cells at 72 and 96 hr after the last treatment of PYR, in addition to a 10% decrease in %T cells at the 1% PYR treatment level at the 96 hr time point (data not shown). Based on these data, PYR would be classified as a sensitizer at 5% and above according to the criteria previously described (Gerberick et al. 1999, 2002). The positive control DNFB (0.15%) also decreased %T cells and increased the number of total lymph node cells, %B cells, and CD86 expression
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Pyrogallol was identified as a skin sensitizer in experimental animal models and by QSAR prediction. Moreover, a number of human studies in individuals exposed to hairdressing chemicals showed that pyrogallol is a contact sensitizer and, according to Banca Dati Sensibilizzanti (ISS, Italy), Pyrogallol is a substance for which a (skin) sensitizing potential cannot be excluded.
Based on the above information, the substance should be classified as H317: May cause an allergic skin reaction
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.