Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 201-762-9 | CAS number: 87-66-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Submission of unpublished data by CTFA. Rabbit eye irritation study.
- Author:
- CLAIROL
- Year:
- 1 979
- Bibliographic source:
- (Cited by CIR, 1991)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: The use of secondary sources of data is acceptable when they are based in a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. The data were collected and reviewed by CIR in a safety assessment of a cosmetic ingredient. Therefore, although the method used is not known, the values presented here are acceptable as they are from a reliable secondary source of toxicological information. The tested substance is applied in a single dose to one of the eyes of the experimental animal; the untreated eye serves as the controlthe degree of eye irritation/corrosion is evaluated by scoring lesions. The duration of the study should be sufficient to evaluate the reversibility or irreversibility of the effects.
- Short description of test conditions: The ocular irritation of pyrogallol was evaluated in rabbits (six/group) after a single exposure; Pyrogallol was applied as powder.
- Parameters analysed / observed: irritation effects were observed. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Pyrogallol
- EC Number:
- 201-762-9
- EC Name:
- Pyrogallol
- Cas Number:
- 87-66-1
- Molecular formula:
- C6H6O3
- IUPAC Name:
- benzene-1,2,3-triol
- Reference substance name:
- unknown impurities
- IUPAC Name:
- unknown impurities
- Test material form:
- not specified
- Details on test material:
- not specified
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not specified
- 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: not specified
- 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: not relevant: the substance was applied as a powder
- Final preparation of a solid: applied as such
FORM AS APPLIED IN THE TEST (if different from that of starting material) : solid (powder)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable
OTHER SPECIFICS: no other specifics available
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: weight 2.5-3.0 kg
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: From: To: not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1% solution of Pyrogallol (in propylene glycol)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1% solution of Pyrogallol (in propylene glycol)
- Lot/batch no. (if required): -
- Purity: - - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- not specified
- Duration of post- treatment incubation (in vitro):
- not specified
- Number of animals or in vitro replicates:
- 6 (males)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: overall
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- other: overall
- Time point:
- other: nor specified
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- other: overall
- Time point:
- other: not specified
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- the 1% solution of Pyrogallol was not an ocular irritant.
- Other effects:
- no other effects were reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Pyrogallol in solution was not irritant.
- Executive summary:
The ocular irritation of the chemical was evaluated in male New Zealand White rabbits (six/group). Pyrogallol was applied as 1% solution of the substance in propylene glycol, into the conjunctival sac.
The eyes were not rinsed after instillation in either treatment group. Untreated eyes served as controls.
Pyrogallol does not induced ocular irritation.
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.
