Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-585-2 | CAS number: 108-46-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 021
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- Method: other: OECD TG 429
0.1, 0.5, 1, 5 and 25% - GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Resorcinol
- EC Number:
- 203-585-2
- EC Name:
- Resorcinol
- Cas Number:
- 108-46-3
- Molecular formula:
- C6H6O2
- IUPAC Name:
- resorcinol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Nulliparous and non pregnant female CBA/J mice were chosen on the basis of previous studies performed in the laboratory in which CBA/J mice showed the best proliferative response. Females were selected since this sex is recommended by the international guidelines. The Breeder was Janvier, Le Genest-Saint-Isle, France. In the main study 28 females were used (seven groups of 4 animals). On the first day of treatment, the animals were 7 to 12 weeks old and the weight variation of the animals minimal (not exceed 20% of the mean weight). Animals were acclimated at least 5 days before study initiation. Animals were assigned by hand procedure and individually numbered on the tail using an indelible marker.
The animal room conditions will be set as follows: Temp: 22 + 2C; relative humidity: 30 to 70%; light/dark cycle: 12h/12h; ventilation: 12 cycles/hr of filtered, non-recycled air. Animals were housed individually in cages with autoclaved sawdust.
Tap water and A04 pelleted diet were available ad libetum. No containments were known to be present in the diet, drinking water or sawdust (bedding) at levels which may be expected to interfere with or prejudice the outcome of the study.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.1, 0.5, 1, 5 and 25%
- No. of animals per dose:
- 28 (Five treated groups of four animals received the test item plus controls)
- Details on study design:
- As equivocal results were obtained in the first experiment (see additional robust study summary) and in order to determine more precisely the EC3 value, the test item was then tested in a second experiment.
In the second study: Five treated groups of four animals receiving the test item Resorcinol (A011) at the chosen concentrations of 0.1, 0.5, 1, 5 and 25%. According to the solubility assay performed in the CIT/Study No. 26936 AHS, the vehicle used in the study was DMF. During the induction
phase, the test item, vehicle or reference item was applied over the ears (25 µL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of
resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). The obtained values were used to calculate stimulation indices (SI).
The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.
Proliferation Assay: The incorporation of 3H-TdR in the vehicle control group was as specified in acceptance criteria, the quantity of cells obtained in each group was satisfactory, the cellularity was correlated with incorporation of 3H-TdR, the cell viability in each group was higher than 70% and the
threshold positive value of 3 for the SI was exceeded in the positive control group. The study was therefore considered valid.
Intravenous injection of 3H-TdR and sampling of auricular lymph nodes Lymph node cell proliferative responses were measured as described by Kimber and Dearman (1991). On day 6 of the experiment, all animals of all groups received a single intravenous injection of 250 µL of 0.9% NaCl containing 20 µCi of 3H-TdR (specific activity of 25 Ci/mmol) via the tail vein. Approximately 5 hours later, the animals were killed by cervical dislocation and the auricular lymph nodes were excised. The lymph nodes were pooled for each experimental group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- linear interpolation of the points on the dose response curve immediately above and below the 3-fold threshold (EC3). The equation used for calculation of EC3 was:
EC3 = c + [(3 - d) / (b - d)] x (a - c) Where a = the lowest concentration giving stimulation > 3; b = the actual stimulation index caused by a; c = the highest concentration failing to produce a stimulation index of 3; and d = the actual stimulation index caused by c.
Results and discussion
- Positive control results:
- Within range.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.58
- Test group / Remarks:
- 0.1% test group
- Parameter:
- SI
- Value:
- 2.87
- Test group / Remarks:
- 0.5% test group
- Parameter:
- SI
- Value:
- 1.97
- Test group / Remarks:
- 1% test group
- Parameter:
- SI
- Value:
- 3.51
- Test group / Remarks:
- 5% test group
- Parameter:
- SI
- Value:
- 5.74
- Test group / Remarks:
- 25% test group
- Key result
- Parameter:
- EC3
- Value:
- 3.67
- Test group / Remarks:
- The EC3 value was determined by linear interpolation of points on the dose-response curve, immediately above and below the 3-fold threshold. Assuming SI3 is between the concentration 1% and 5%: EC3=1 + [(3-1.97)/(3.51-1.97)] x (5-1) = 3.67
Any other information on results incl. tables
Systemic clinical signs and mortality: Hypoactivity, piloerection and dyspnea were observed on day 3 in 1/4 and 2/4 animals of the treated groups 4 and 5, respectively.
Local irritation: No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.
Proliferation assay: The incorporation of 3H-TdR in the vehicle control group was as specified in acceptance criteria, the quantity of cells obtained in each group was satisfactory, the cellularity was correlated with incorporation of 3H-TdR, the cell viability in each group was higher than 70% and the threshold positive value of 3 for the SI was exceeded in the positive control group. The study was therefore considered valid.
A dose-related increase in the stimulation index (except at the concentration of 1%) was noted and the threshold positive value of 3 was exceeded at the concentrations = 5%.
The EC3 value for the test item Resorcinol (A011) calculated on the basis of the results obtained in this experiment was 1.4%.
Dose | # of nodes per group | DPM per group | DPM per node |
0.1% | 8 | 514.23 | 64.28 |
0.5% | 8 | 933.88 | 116.74 |
1% | 8 | 639.94 | 79.99 |
5% | 8 | 1142.67 | 142.83 |
25% | 8 | 1869.67 | 233.71 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Positive. Resorcinol (AO11) is considered a moderate skin sensitizer under the conditions of this study.
Classification: Skin Sens. 1B H317 - Executive summary:
A mouse local lymph node assay (LLNA) was conducted in accordance with OECD TG 429 (, 2005a; RL=1). The first experiment resulted in equivocal findings at concentrations of 0, 2.5, 5, 10, 25 and 50%. There were four animals per treatment group including negative and positive controls. Lymphoproliferative responses observed in negative control groups fell within historical ranges, while significant lymphoproliferation was observed with α-hexylcinnamaldehydr at 25%, thus validating the sensitivity of the test system. A dose related increase in the Stimulation Index (SI) was not seen. In the second experiment five treated groups of four animals were administered resorcinol at concentrations of 0.1, 0.5, 1.0, 1.5 and 25%. Clinical signs included hypoactivity, piloerection and dyspnea on day 3 in 1 of 4 animals in the 5% group and 2 of 4 animals in the 25% group. There was no effect on body weight and no cutaneous reactions; there were no noteworthy increases in ear thickness. A dose-related increase in the stimulation index (except at a concentration of 1%) was noted and the threshold positive value of 3 was exceeded at concentrations equal to 5%. Resorcinol was considered positive in the LLNA and a moderate skin sensitizer under the conditions of this study.
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.