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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/07/2019-03/09/2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 402
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 09th October 2017
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 3 female / group (1 for dose range finding study and 2 for main study)
Source : Invivo Biosciences, Shed No. 23, Khatha No.3169, Assessment No. 154, Kodigehalli Village, Magadi Road,
Bengaluru-560091.
Age at treatment: 09 to 10 weeks
Body weight range at treatment: Females: 209.3 to 211.5 g
Identification : By rat accession number. Identification of individual rats is by cage card and crystal violet and turmeric solution body
markings. The temporary body marking during acclimatization period was done with crystal violet.
The rat accession numbers were allotted during the course of the study and was included in raw data and reported.
Acclimatization: After physical examination for good health and suitability for experiment, the rats were acclimatized for six and ten days
before treatment for dose range finding and main study respectively under standard laboratory conditions.
Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.
Only healthy and intact skin rats free of clinical signs were used for this study.
Animal care practices were conformed to the requirements of the CPCSEA.
This protocol was approved by Institutional Animal Ethics Committee (IAEC) of Eurofins Advinus Limited (Proposal No. 002/Aug-2018, dated:
28 August 2018).
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- 0.4 mL of the milli-Q water
- Details on dermal exposure:
- Approximately 24 hours before treatment, the hair on the dorsolateral thoracic surface of the skin was clipped (approximately 10 x 8 cm) with an electric clipper (Aesculap - Germany). Care was taken to avoid abrading the skin, which could alter its permeability.
Based on the individual body weight, the test item at the dose of 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding 0.4 mL of the milli-Q water and completely transferred on to the cotton gauze (size: Females: 8 x 5 cm of 6 ply) and applied directly (semi-occlusive) to the clipped skin of the rat to cover about 10% of body surface of the rat. It was secured in position by adhesive tape wound around the torso. - Duration of exposure:
- The test item contact period with the skin was for 24 hours.
After the 24 hours contact period, the dressing was removed and the applied area was washed with deionised water and wiped dry using clean towel. - Doses:
- As per the MSDS provided by sponsor, the acute dermal toxicity for Pyrogallol\ Pyrogallic acid in rats is >2000 mg/kg. Hence, an initial limit dose of 2000 mg/kg body weight was tested with 1 female rat (dose range finding study). As there was no mortality at dose range finding study. The main study was conducted with 2 further animals to confirm the classification outcome. There was no test item-related mortality. The subsequent dosing was done at least 48 hours after the previous dosing.
- No. of animals per sex per dose:
- 3 female / group (1 for dose range finding study and 2 for main study) all trated whit 2000 mg/kg of test item.
- Control animals:
- not required
Results and discussion
- Preliminary study:
- An initial limit dose of 2000 mg/kg body weight was tested with 1 female rat (dose range finding study). As there was no mortality at dose range finding study. The main study was conducted with 2 further animals to confirm the classification outcome. There was no test item-related mortality.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- 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:
- There was no mortality observed at 2000 mg/kg body weight.
- Clinical signs:
- There were no clinical signs in any of the rats.
- Body weight:
- All rats gained body weight throughout the observation period at all the tested doses.
- Gross pathology:
- No abnormality was detected at necropsy.
Any other information on results incl. tables
Individual body weight, body weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
Pre-terminal deaths |
||||
Initial (Day 1 - at treatment) |
8th day |
Weight change (day 8 – Initial) |
15th day |
Weight change (day 15 – Initial) |
||||
G1 and 2000 DRF |
Rw4511 |
F |
210.0 |
219.6 |
9.6 |
225.1 |
15.1 |
0 |
G1 and 2000 Main study |
Rw4512 |
F |
209.3 |
221.8 |
12.5 |
227.6 |
18.3 |
0 |
Rw4513 |
F |
211.5 |
217.4 |
5.9 |
231.0 |
19.5 |
0 |
Individual test item application, clinical signs, skin reactionand necropsy findings
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G1 and 2000
|
16 August 2019 and 10:38 AM |
Rw4511 |
F |
210.0 |
420 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G1 and 2000
|
20 August 2019 10:39 AM to |
Rw4512 |
F |
209.3 |
419 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Rw4513 |
F |
211.5 |
423 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 2000
|
Rw4511 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observations |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 2000
|
Rw4512 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rw4513
|
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Legend:
F: Female
N: Normal
h: hour min: minutes
NAD: No abnormality detected
Er: Erythema
Ed: Edema
Score 0: No Erythema/Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results of the present study (acute dermal toxicity), the test item, Pyrogallol/ Pyrogallic acid are classified as follows:
The test item is classified as “Category 5” (the dermal LD50 range of 2000 < Acute Toxicity Estimates ≤ 5000 mg/kg) as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Seventh Revised Edition, United Nations (2017). ST/SG/AC.10/30/Rev.7, as there was no mortality observed at 2000 mg/kg body weight. - Executive summary:
The acute dermal toxicity of Pyrogallol/Pyrogallic acid was tested with dose 2000 mg/kg body weight with 1 female for dose range finding study, followed by additional 2 females for main study in Wistar rats.
Based on the individual body weight, the test item at the dose of 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding 0.4 mL of milli-Q water and completely transferred on to the cotton gauze (size: Females: 8 x 5 cm of 6 ply) and applied directly (semi-occlusive) to the clipped skin of the rat to cover about 10% of body surface of the rat. It was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours.
After the 24 hours contact period, the dressing was removed, and the applied area was washed with water and wiped dry using clean towels.
All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the site of application was observed for skin reactions at 24, 48 and 72 hours after removal of test chemical using the Draize method. Body weights were recorded on days 1, 8 and 15. All the rats gained weight during experimental period. At the end of observation period, all surviving animals were euthanized and subjected to necropsy.
There were no skin reactions and clinical signs in any of the rats. There were no abnormalities detected at the necropsy.
Based on the present study results, the acute dermal LD50of Pyrogallol/ Pyrogallic acidis more than 2000 mg/kg body weight in female Wistar rats. Test item is also considered as not irritant to the skin in female Wistar rats.
The test item,Pyrogallol\ Pyrogallic acidis classified as follows:
The test item is classified as “Category 5” (the dermal LD50range of 2000< Acute Toxicity Estimates ≤5000 mg/kg) as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Seventh Revised Edition, United Nations (2017). ST/SG/AC.10/30/Rev.7,as there was no mortality observed at 2000mg/kg body weight.
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