Pyrogallol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

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:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: method described by Gerberick and Ryan (1989)

Deviations:

yes

Remarks:

modification of the method was used but it was not detailed

Principles of method if other than guideline:

- Principle of test: t has been noted that some irritants can also induce proliferation in the draining lymph nodes, thereby manifesting as false positives in the LLNA (Montelius et al., 1994; Basketter et al., 1998). Thus, it was important to determine whether irritation cont ributed to the
positive responses observed in the LLNA.
- Short description of test conditions: The Authors tried to establish the minimal irritating concentration (i.e. the lowest concentration of chemical to elicit a significantly greater ear swelling response than that observed in the vehicle control group) and the maximal non-irritating concentration (the
highest concentration producing ear swelling that is not significantly different from the vehicle control).
- Parameters analysed / observed: The percentage of ear swelling was calculated for each mouse as the [(mean thickness of the post-treated
ear/mean thickness of the pre-treated ear) × 100]−100.

GLP compliance:

not specified

Remarks:

refer to section "any other information on materials and methods" for remarks related to GLP compliance for a test performed after 2008, 1st June

Test material

Test material information

Constituent 1

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

impurity 1

Reference substance name:

unknown impurities

IUPAC Name:

unknown impurities

Test material form:

not specified

Details on test material:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
purchased from Sigma (St. Louis, MO).
- 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:
Initial studies on the solubility of PYR demonstrated that the compound was soluble at concentrations of 75% (w/v) and below in acetone:olive oil
- 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 solutions were prepared daily in the vehicle 4:1 acetone:olive oil (AOO) as recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; Dean et al., 2001).
- Final preparation of a solid:
not relevant

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: white odorless crystal (FW 126.11, CAS No.87-66-1)

Test animals

Species:

mouse

Strain:

Balb/c

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

other: acetone: olive oil

Controls:

other: 0.15% 2,4-dinitrofluorobenzene (DNFB) and 25% hexyl cinnamic aldehyde (HCA)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each mouse received 12.5 μl of test chemical on both sides of each ear
- Concentration (if solution): 0,125%, 0,25%, 1%, 5%, 10%

VEHICLE
- Amount(s) applied (volume or weight with unit): Each mouse received 12.5 μl ofvehicle on both sides of each ear
- Concentration (if solution): not specified
- Lot/batch no. (if required): not specified
- Purity: not specified

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Naïve animals were left untreated
- Concentration (if solution): not specified

POSITIVE CONTROL
- Amount(s) applied (volume or weight): not specified
- Concentration (if solution): not specified

Duration of treatment / exposure:

four consecutive days.

Observation period:

24 (± 2) hrs

Number of animals:

6–8 mice for each treatment group

Results and discussion

In vivo

Results

Irritation parameter:

other: positive irritant response

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

PYR is irritating to the skin at concentrations as low as 0.125%.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

PYR induced a positive response in the IRR at concentrations as low as 0.125%.
Because PYR also induced a positive irritant response, it should be classified as an irritant