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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992

Materials and methods

Principles of method if other than guideline:
The skin sensitization potential of 2% Picramic Acid in distilled water was evaluated using 25 female albino guinea pigs.
GLP compliance:
not specified

Test material

1
Chemical structure
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

In vivo test system

Test animals

Species:
guinea pig
Sex:
female
Details on test animals and environmental conditions:
25 female albino guinea pigs.
Experimental and untreated control groups consisted of 15 and 10 animals, respectively.

Study design: in vivo (non-LLNA)

Details on study design:
The skin sensitization potential of 2% Picramic Acid in distilled water (1 :10, 1 :100,
and 1 :1000 dilutions) was evaluated using 25 female albino guinea pigs (weights
350-380 g).
Experimental and untreated control groups consisted of 15 and 10 animals, respectively. The guinea pigs used were from strains whose sensitizing capacity had been tested with 2,4-dinitrochlorobenzene.
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 (Magnusson and Kligman, 1969). The test substance (0.3 ml) was then intracutaneously injected into the side of each animal during five successive day.
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 dilution of 2% Picramic Acid (effective concentration = 0.2%) 24 h after removal of the challenge patch.

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: daily readings
Remarks on result:
other: mild sensitizer
Remarks:
under test conditions

Applicant's summary and conclusion

Conclusions:
Picramic Acid was a mild sensitizer.
Executive summary:

The skin sensitization potential of 2% Picramic Acid in distilled water (1 :10, 1 :100, and 1 :1000 dilutions) was evaluated using 25 female albino guinea pigs.

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 (Magnusson and Kligman, 1969). 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. 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.

Picramic Acid was a mild sensitizer.