Registration Dossier

Administrative data

Description of key information

An overall consideration indicates generally a mild reaction severity of 2,4 -dinitrophenol onto the skin, so the substance can be considered: MODERATELY IRRITANT.
2,4-DNP cause cataract if injected into the eye and if swallowed, but no studies for the irritation to the eyes are available. Skin irritation studies revelade that 2,4- dinitrophenol is irritant, so asing on the major sensitivity of the eyes respect to the skin, it could concluded that 2,4-DNP it can be considered also an eye irritant .

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data have been obtained from secondary source.
Principles of method if other than guideline:
Standard Draize test. Details of the Method have not been specified.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Duration of treatment / exposure:
4 weeks (intermittent)

Reaction severity: mild

Interpretation of results:
other: mild irritating
Conclusions:
The result of the Standard Draize test for 2,4-dinitrophenol is mild irritating.
Executive summary:

Data have been obtained from secondary source that mentions JIHTAB Journal of Industrial Hygiene and Toxicology.

The method used was the Standard Draize test on rabbit, with the dose of 300 mg and the duration of the test was 4 weeks (intermittent). Result indicates a mild reaction severity of 2,4 -dinitrophenol onto the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Different studies have been considered to assess the irritation on skin and eye of 2,4-dinitrophenol.

Many tests have been performed on the shaved abdominal part of rabbit’s body and to the ears by solutions in solvents as ethanol and propylene glycol. The concentration of 2,4-dinitrophenol varied from 3 to 4 % (Spencer et al., 1948, Dow Chemical Co, 1940). Results indicate that the solutions of 2,4-dinitrophenol applied in to the ears are not irritant.

However, the 4% solution applied by bandage on shaved abdomen showed signs of irritation, on a range of “moderate simple irritation” to very slight irritant. No score of results were reported.

Only one test used the dose of 300 mg for 4 week (intermittent) by a Draize test, on rabbits (JIHTAB, 1948).

This test has been chosen as representative for this endpoint. Details of the method and of the results have been not specified, but the study was performed as a Standard Draize test (both OECD and EU methods use the Draize test scoring). The animal tested was a rabbit, a sensitive specie. Anyway, despite the lack of information, all tests reported execute on abdominal shaved area of animals, supported the result of this test.

Data on human exposure confirm that 2,4-dinitrophenol as a solid skin irritant (HSDB).

An overall consideration indicates generally a mild reaction severity of 2,4 -dinitrophenol onto the skin, so the substance can be considered: MODERATELY SKIN IRRITANT .

 

2,4-DNP cause cataract if injected into the eye and if swallowed, but no studies for the irritation to the eyes are available. Skin irritation studies revelade that 2,4- dinitrophenol is irritant, so asing on the major sensitivity of the eyes respect to the skin, it could concluded that 2,4-DNP it can be considered also an eye irritant .


Justification for selection of skin irritation / corrosion endpoint:
This test has been chosen as representative for this endpoint. Details of the method and of the results have been not specified, but the study was performed as a Standard Draize test (both OECD and EU methods use the Draize test scoring). Anyway, despite the lack of information, all tests reported execute on abdominal shaved area of animals, supported the result of this test.

Justification for selection of eye irritation endpoint:
No studies for the irritation to the eyes are available. Skin irritation studies revelade that 2,4- dinitrophenol is irritant. Basing on the major sensitivity of the eyes respect to the skin, it could concluded that 2,4-DNP it can be considered an eye irritant .

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

SKIN/EYE IRRITATION-CORROSION

On the basis of tests performed on animals and exposure observations on humans, 2,4 -dinitrophenol can be classified, according to CLP Regulation 1272/2008, H315: causes skin irritation, category 2.

2,4 -dinitrophenol can develop cataracts after ocular injection at low concentrations and burns on eye and if swallowed, but no studies for the irritation to the eyes are available. Skin irritation studies revelade that 2,4- dinitrophenol is irritant, so asing on the major sensitivity of the eyes respect to the skin, it could concluded that 2,4-DNP it can be considered also an eye irritant . H319: causes serious eye damage, category 1.

Due to the high toxicity of 2,4 -DNP by dermal and inhalation exposure, the classification for the irritation (eye and skin) could be covered by classification of acute toxicity. Furthermore, it has followed the classification from the European Commision Decision, that not consider skin and eye irritation.