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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-498-2 | CAS number: 121-79-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-17 to 2017-04-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A Bovine Corneal Opacity and Permeability Assay (OECD Guideline number 437) with propyl gallate was performed (Eurofins Munich / BSL Munich Project No. 167610). Based on the results of this test further in vivo testing for assessing acute eye irritation/corrosion is necessary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2 October 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propyl 3,4,5-trihydroxybenzoate
- EC Number:
- 204-498-2
- EC Name:
- Propyl 3,4,5-trihydroxybenzoate
- Cas Number:
- 121-79-9
- Molecular formula:
- C10H12O5
- IUPAC Name:
- propyl 3,4,5-trihydroxybenzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Source and lot/batch No.of test material: 201601004
- Expiration date of the lot/batch: 01.01.2019
- Purity: 99.93 %
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633, Sulzfeld, Germany
- Age at study initiation: approximately 39 weeks old
- Weight at study initiation: >2 kg
- Housing: ABS-plastic or Noryl rabbit cages, floor 4200 cm2, in an air-conditioned room
- Diet (e.g. ad libitum): free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water (e.g. ad libitum): free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: adequate acclimatisation period (at least 5 days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item was applied to the test site
- Duration of treatment / exposure:
- single treatment, 1h
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with physiological saline 0.9% NaCl 1 hour after the application.
- Time after start of exposure: 1 h
SCORING SYSTEM: Grading System for Ocular Lesion (for details see Table 1 in "Any other information on material and methods")
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Irritant / corrosive response data:
- After the application into the eye of one male NZW rabbit the test item produced severe irritant occular effects (see Table 2 and Table 3 in "Any other information on results"). Local effects at the treated eye and clinical signs were observed (see Table 3). The inclined position of the head 72 hours after application is considered to be related to the local effects observed at the treated eye and not due to systemic effects of the test item. Before fluorescein examination at the end of the observation period of 72 hours the animal was euthanised for animal welfare reasons. Conjunctival redness, chemosis, hypersecretion, corneal effects and iris lesion were observed and described in Table 2.
- Other effects:
- - Lesions and clinical observations: after 1 hour slight hypersecretion, after 24 hours moderate hypersecretion, after 48 and 72 hours severe hypersecretion
Any other information on results incl. tables
Table 2: Eye Irritation Scores - Animal No. 1
Observation |
Eye Irritation Scores Post-Application After |
||||||||
1(1h) |
2(24h) |
3(48h) |
4(72h) |
|
|||||
T |
C |
T |
C |
T |
C |
T |
C |
Average Score (24, 48 and 72 hours) |
|
Redness |
0 |
0 |
1# |
0 |
1 |
0 |
1 |
0 |
1.00 |
Chemosis |
2 |
0 |
2 |
0 |
2 |
0 |
2 |
0 |
2.00 |
Iris |
n.a.* |
0 |
2** |
0 |
2** |
0 |
2 |
0 |
2.00 |
cornea |
3 |
0 |
2 |
0 |
2 |
0 |
2 |
0 |
2.00 |
t= test item; c= control; #= upper rim of conjunctiva and nicticating membrane discoloured white; *=due to complete opacity of the cornea the iris was not visible and thus could not be evaluated; **= no reaction to light
Table 3: Clinical Signs - Animal No. 1
Time Post-Application | Local Findings / Comments | Systemic Findings | |
Test Item | Control | Test Item | |
1 h | slight hypersecretion | nsf | nsf |
24 h | moderate hypersecretion | nsf | nsf |
48 h | severe hypersecretion | nsf | nsf |
72 h | severe hypersecretion | nsf | head inclined § |
nsf= no specific findings; h= hour(s); §= euthanised for ethical reasons
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In an in vivo acute eye irritation/corrosion study in one rabbit accroding to OECD 405, Propyl gallate produced severely irritant effects, which are not expected to reverse.
- Executive summary:
In a primary eye irritation study according to OECD 405, 0.1 g of propyl gallate (99.93 % purity) was applied into the conjunctival sac of one eye of 1 male, 39 weeks old, New Zealand White rabbit. The test substance remained in the eye for 1 hour and was rinsed afterwards with physiological saline (0.9 % NaCl). The animal then was observed for 72 hours. Irritation was scored by the method of Draize after 1, 24, 48 and 72 h.
Under the conditions of the present study, a single ocular application of the test item Propyl gallate to one rabbit at a dose of 0.1 g produced severely irritant effects including conjunctival redness, chemosis, hypersecretion, corneal effects and iris lesion (iridial response grade 2 for 72 hours), which are not expected to reverse.
In this study, propyl gallate is a severe eye irritant based on CLP criteria.
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.