2-amino-4,6-dinitrophenol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Amended Safety Assessment of Sodium Picramate and Picramic Acid

Author:

Lillian C. Becker, Wilma F. Bergfeld, Donald V. Belsito, Curtis D. Klaassen, JamesG.Marks Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, and F. Alan Andersen

Year:

2009

Bibliographic source:

International Journal of Toxicology 28(Suppl 3) 205S-216S, 2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

The skin sensitization potential of Picramic Acid was evaluated using female albino guinea pig.

GLP compliance:

not specified

Type of study:

patch test

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-4,6-dinitrophenol

EC Number:

202-544-6

EC Name:

2-amino-4,6-dinitrophenol

Cas Number:

96-91-3

Molecular formula:

C6H5N3O5

IUPAC Name:

2-amino-4,6-dinitrophenol

Constituent 2

Reference substance name:

Picramic acid

IUPAC Name:

Picramic acid

Details on test material:

- Name of test material (as cited in study report): Picramic acid
- Molecular formula (if other than submission substance): C6H5N3O5
- Molecular weight (if other than submission substance): 199.12 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity : 98%
- Impurities (identity and concentrations): 2%

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: No data available
- Albino Guinea pigs were used
- Age at study initiation: No data available
- Weight at study initiation: 350-380g
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: Intracutaneously

Vehicle:

water

Remarks:

Distilled water

Induction 2

Concentration / amount:

2% (1:10, 1:100, and 1:1000 dilutions)

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Remarks:

Distilled water

Challenge 2

Concentration / amount:

2% (1:10, 1:100, and 1:1000 dilutions)

No. of animals per dose:

Test animals: 15
Control animals: 10

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 5 successive days
- Test groups:15
- Control group:10
- Site: intracutaneously injected into the side of each animal
- Frequency of applications: 5
- Duration: 5 successive days
- Concentrations: 2% (1:10, 1:100, and 1:1000 dilutions)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Four weeks after the end of pretreatment
- Exposure period: 24 h
- Test groups: 15
- Control group: 10
- Site: Untreated side of each animal.
- Concentrations: 2% (1:10, 1:100, and 1:1000 dilutions)
- Evaluation (hr after challenge): 24 hrs, 48 hrs

OTHER: Two to 3 h prior to test initiation, the 15 experimental animals, clipped free of hair, were pretreated with the, test substance according to the maximization test procedure

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

2% (1:10) (effective concentration = 0.2%)

No. with + reactions:

4

Total no. in group:

15

Clinical observations:

Light erythema

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2% (1:10) (effective concentration = 0.2%). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: Light erythema.

Any other information on results incl. tables

Slight erythematous skin alterations were observed during the five days of pretreatment. Four of the 15 guinea pigs treated with the test substance had allergic reactions that were classifed as light erythema (Draize score = 1) to the 1:10 dilution of 2% Picramic Acid (effective concentration = 0.2%) 24 h after removal of the challenge patch. Reactions were not observed at 48 h.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Picramic Acid is to be a mild sensitizer to the skin of female guinea pigs

Executive summary:

Skin sensitizing study was conducted on albino guinea pigs for the test compound picramic acid. 2% picramic Acid in distilled water (1 :10, 1 :100, and 1 :1000 dilutions) was evaluated.

 

Experimental and untreated control groups consisted of 15 and 10 animals, respectively. Two to 3 h prior to test initiation, the 15 experimental animals, clipped free of hair, were pretreated with the test substance according to the maximization test procedure. The test substance (0.3 ml) was then intracutaneously injected into the side of each animal during five successive days. The elicitation phase of treatment was begun four weeks after the end of pretreatment, and involved administration of the test substance, via a challenge patch, to the untreated side of each animal. Skin reactions were evaluated according to the Draize scale: 0 (No erythema) to 4 (Severe erythema with scar formation). Slight erythematous skin alterations were observed during the five days of pretreatment. Four of the 15 guinea pigs treated with the test substance had allergic reactions that were classifed as light erythema (Draize score = 1) to the 1: 10 of 2% Picramic Acid (effective concentration = 0.2%) 24 h after removal of the challenge patch. Reactions were not observed at 48 h.

 

Picramic Acid is to be a mild sensitizer to the skin of female guinea pigs.

 

According to the publication, the test material picramic acid classifies as a skin sensitizer.