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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-05 to 2017-04-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Test item was used as deliverd by the sponsor. In order to ensure good skin contact, it was moistened with the vehicle.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9-10 weeks old, females 12-13 weeks old
- Weight at study initiation: males: 233-259 g, females: 214-227 g
- Fasting period before study:
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): relative humidity of 55 ± 10%
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Aqua ad injectionem
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10% of the total body surface.
- % coverage: approximately 10% of the total body surface.
- Type of wrap if used: The test item was held in contact with the skin by a dressing throughout a 24-hour period. This consisted of a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the residual test item will be removed by using water or another appropriate solvent if practicable.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dose of 2000 mg/kg body weight.
- For solids, paste formed: yes
VEHICLE
- Lot/batch no. (if required):AlleMan Pharma, Lot. No. 605070, expiry date 2019-04-30 - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the application), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:
- clinical signs: several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose), and once daily thereafter, until the end of the observation period. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- histopathology: In absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
- primary skin irritation: Signs of erythema and oedema were assessed using the scoring system (Table 1 in "Any other information on material and methods") laid down in OECD Guideline 404.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No specific findings were determined
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table 2: Absolute Body Weights in g and Body Weight Gain in %.
Test Group | Animal No. | Dose (mg/kg bw) | Body Weight (g) on Day | BW gain in Comparison to Day 1 (%) | ||
1 | 8 | 15 | ||||
Males | 21 | 2000 | 245 | 269 | 299 | 22 |
22 | 2000 | 255 | 290 | 326 | 28 | |
23 | 2000 | 259 | 292 | 335 | 29 | |
24 | 2000 | 245 | 270 | 308 | 26 | |
25 | 2000 | 233 | 252 | 275 | 18 | |
Females | 26 | 2000 | 214 | 227 | 240 | 12 |
27 | 2000 | 224 | 223 | 236 | 5 | |
28 | 2000 | 216 | 213 | 210 | -3 | |
29 | 2000 | 227 | 223 | 234 | 3 | |
30 | 2000 | 214 | 220 | 237 | 11 |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Propyl gallate in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study (OECD 402, limit test), a group of young adult Wistar rats (5 males and 5 females) were dermally exposed to Propyl gallate (purity 99%) moistened with Aqua ad injectionem for 24 hours to approximately 10% of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days. No mortality and neither signs of toxicity nor signs of irritation occurred. The dermal LD50 value of Propyl gallate in Wistar rats was established to exceed 2000 mg/kg body weight.
Propyl gallate is of low toxicity based on the results of this study and does therefore not warrant for classification according to CLP criteria.
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