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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

 

Oral:

In a non-guideline gavage study, the acute oral toxicity of technical synthetic pyrogallol (TS pyrogallol; 92.2 % w/w) was assessed in male and female Sprague Dawley rats. Males were exposed to 566, 800, 1131 or 1600 mg TS pyrogallol/kg bw (six/group). Females were exposed to 283, 400, 566, 800, or 1131 mg TS pyrogallol/kg bw (six/group).

Acute oral median lethal dose (LD50) values (Weil method) were 1270 mg/kg in males and 800 mg/kg in females for TS pyrogallol.

 

Inhalation:

No study available.

As second route of exposure, dermal exposure was assessed to be the most rapresentative one.

 

Dermal:

There were no clinical signs and pre-terminal deaths in any of the rats.

All rats gained body weight throughout the observation period at all the tested doses.

No abnormality was detected at necropsy.

Based on the present study results, the acute dermal LD50 of Pyrogallol/ Pyrogallic acid is more than 2000 mg/kg body weight in female Wistar rats. Test item is also considered as irritant to the skin.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
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
Qualifier:
according to guideline
Guideline:
other: test procedures which are described in detail by Kverno (1954) and Kverno et al, (1965)
Deviations:
not specified
Principles of method if other than guideline:
- Principle of test: calculation of the daily chemical dose ingested in mg/kg/day during the wheat test on deer mice and its resultant effects on mortality are also presented for most of the 696 chemicals. This calculated value, when used along with the ALD or LD50, should permit a rough estimate of the potential subacute toxicity of any tested chemical on wild mammals for which both types of data are available
- Short description of test conditions: The Twenty-five wheat seeds, treated with 2.0% (w/w) Pyrogallol, were placed in the cage of each mouse daily for 3 days.number of wheat seeds consumed daily was recorded, and the total number of treated seeds consumed by all mice during the 3-day
period was substracted from the total number of seeds available. The difference was converted into what was termed the feed reduction (FR), defined as the percentage of seeds refused
- Parameters analysed / observed: feed consumption
GLP compliance:
not specified
Test type:
other:
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: The chemicals included in the tests were technical or analytical grade pesticides and other commercially available or experimental chemicals. They were purchased from various commercial sources or contributed by cooperating chemical companies.
For presentation purposes, they have been arranged by Chemical Abstracts Registry Number (CASRN), and are identified by an accepted trade, coined, product or other chemical name that is generally not included in the 8th or 9th Collective Index of the Chemical Abstracts Service
- 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: seeds treated with 2.0% (w/w) Pyrogallol
- Final preparation of a solid: not specified

FORM AS APPLIED IN THE TEST (if different from that of starting material) not specified

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable

OTHER SPECIFICS: not specified
Species:
mouse
Strain:
other: deer mice
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: average weight 20 g
- Fasting period before study: not specified
- Housing: placed in the cage of each mouse daily for 3 days
- Diet (e.g. ad libitum): The number of wheat seeds consumed daily was recorded, and the total number of treated seeds consumed by all mice during the 3-day period was substracted from the total number of seeds available.
- 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
Route of administration:
oral: feed
Vehicle:
not specified
Doses:
average weight of individual wheat seeds (50 mg)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 3 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: N
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: not specified
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
other: LDfr
Remarks:
feed reduction dose (calculated)
Effect level:
1 240 other: mg/kg/day
Based on:
test mat.
Mortality:
LDfr, represented the average amount of chemical, in mg/kg/ day, that was ingested by each animal over the 3-day test period without killing more than 50% of the test animals
Clinical signs:
not specified
Body weight:
not specified
Gross pathology:
not specified
Other findings:
- Organ weights: not specified
- Histopathology: not specified
- Potential target organs: not specified
- Other observations: not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LDfr (feed reduction) for Pyrogallol was 1240 mg/kg/day.
Endpoint:
acute toxicity: oral
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
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.
- Short description of test conditions: rats (male and female) was administered the test substance by oral route (gavage) at different doses, dissolved in distillated water. Mortality was observed.
- Parameters analysed / observed: acute oral median lethal dose (LD50) values (Weil method) and other effects.
GLP compliance:
not specified
Test type:
other: acute oral toxicity
Limit test:
no
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: test substance was diluted to a concentration of 500 mg/mI of distilled water
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable

OTHER SPECIFICS: synthetic Pyrogallol: 92.2% w/w
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
.TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: males: weight 249-305 g and females: weight 191-240 g
- Fasting period before study: not specified
- 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
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distillated water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not specified
- Lot/batch no. (if required): not required
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): not specified

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified
Doses:
1) male: 566, 800, 1131 or 1600 mg/kg (synthetic Pyrogallol)
2) female: 283, 400, 566, 800, or 1131 mg/kg (synthetic Pyrogallol)
No. of animals per sex per dose:
1) 24 male rats
2) 24 female rats
Control animals:
yes
Remarks:
Six male and 6female control animals were dosed with 4.5 ml of distilled water/kg of body weight.
Details on study design:
- Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes/no not specified
- Other examinations performed: not specified
Statistics:
95% confidence limits
Preliminary study:
not specified
Sex:
male
Dose descriptor:
LD50
Effect level:
1 270 mg/kg bw
Based on:
test mat.
95% CL:
> 1 054 - < 1 330
Sex:
female
Dose descriptor:
LD50
Effect level:
800 mg/kg bw
Based on:
test mat.
95% CL:
> 664 - < 964
Mortality:
observed
Clinical signs:
cyanosis, reduced activity, reduced muscle tone, body tremors, ataxia, lacrimation, salivation, piloerection, coolness to the touch, hunched posture, pale extremities and general soiling.
Body weight:
not specified
Gross pathology:
Gross necropsy revealed cyanosis, dark and/or enlarged spleen, dark kidneys, brown or pale liver and lungs, distension of the stomach and bladder, and fluid in the intestines
Other findings:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
According to CLP criteria, the substance is classified as harmful if swallowed.
Executive summary:

In a non-guideline gavage study, the acute oral toxicity of technical synthetic pyrogallol (TS pyrogallol; 92.2 % w/w) was assessed in male and female Sprague Dawley rats. Males were exposed to 566, 800, 1131 or 1600 mg TS pyrogallol/kg bw (six/group). Females were exposed to 283, 400, 566, 800, or 1131 mg TS pyrogallol/kg bw (six/group).

Acute oral median lethal dose (LD50) values (Weil method) were 1270 mg/kg in males and 800 mg/kg in females for TS pyrogallol.

Endpoint:
acute toxicity: oral
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
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.
- Short description of test conditions: rats (male and female) was administered the test substance by oral route (gavage) at different doses, dissolved in distillated water. Mortality was observed.
- Parameters analysed / observed: acute oral median lethal dose (LD50) values (Weil method) and other effects.
GLP compliance:
not specified
Test type:
other: acute oral toxicity
Limit test:
no
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: test substance was diluted to a concentration of 500 mg/mI of distilled water
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable

OTHER SPECIFICS: 98.8% w/w Pyrogallol
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
.TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: males: weight 249-305 g and females: weight 191-240 g
- Fasting period before study: not specified
- 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
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distillated water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not specified
- Lot/batch no. (if required): not required
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): not specified

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not specified
Doses:
1) male: 800, 1131, 1600, or 2261 mg/kg (natural Pyrogallol)
2) female: 566, 800, 1131, or 1600 mg/kg (natural Pyrogallol)
No. of animals per sex per dose:
1) 24 male rats
2) 24 female rats
Control animals:
yes
Remarks:
Six male and 6female control animals were dosed with 4.5 ml of distilled water/kg of body weight.
Details on study design:
- Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes/no not specified
- Other examinations performed: not specified
Statistics:
95% confidence limits
Preliminary study:
not specified
Sex:
female
Dose descriptor:
LD50
Effect level:
848 mg/kg bw
Based on:
test mat.
95% CL:
> 733 - < 982
Sex:
male
Dose descriptor:
LD50
Effect level:
1 270 mg/kg bw
Based on:
test mat.
95% CL:
> 839 - < 1 923
Mortality:
observed
Clinical signs:
cyanosis, reduced activity, reduced muscle tone, body tremors, ataxia, lacrimation, salivation, piloerection, coolness to the touch, hunched posture, pale extremities and general soiling.
Body weight:
not specified
Gross pathology:
Gross necropsy revealed cyanosis, dark and/or enlarged spleen, dark kidneys, brown or pale liver and lungs, distension of the stomach and bladder, and fluid in the intestines
Other findings:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
According to CLP criteria, the substance is classified as harmful if swallowed.
Executive summary:

In a non-guideline gavage study, the acute oral toxicity of technical natural pyrogallol (TN pyrogallol; 98.8 % w/w) was assessed in male and female Sprague Dawley rats. Males were exposed to 800, 1131, 1600, or 2261 mg TN pyrogallol/kg bw (six/group). Females were exposed to 566, 800, 1131, or 1600 mg TN pyrogallol/kg bw (six/group).

Acute oral median lethal dose (LD50) values (Weil method) were 1270 mg/kg in males and 848 mg/kg in females for TN pyrogallol.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
848 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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).
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
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.
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.

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
10:40 AM

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
1 (reliable without restriction)

Additional information

Justification for classification or non-classification

The acute oral median lethal dose (LD50cut-off value) of the substanceinrats was found to be 1270 mg/kg body weight for males and 800 mg/kg body weight for females. Based on this information, the substance is classified

ORAL Toxicity:Category 4, H302

The acute dermal median lethal dose (LD50cut-off value) of the substanceinrats was found to be > 2000 mg/kg body weight for females. Based on this information, the substance should not be classified for acute dermal toxicity. Nevertheless, the hazard statement code H312 is part of the current harmonized classification (which was attributed to the substance before the availability of the current dermal toxicity test) and, for the time being, the substance will still be classified for DERMAL Toxicity: Category 4, H312

No data are available for the acute toxicity by inhalation route.

Nevertheless, the hazard statement code H332 is part of the current harmonized classification and, for the time being, the substance will still be classified for INHALATION Toxicity:Category 4, H332