2-nitro-p-phenylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

ASSESSMENT OF THE ACUTE TOXICITY AND POTENTIAL IRRITANCY OF HAIR DYE CONSTITUENTS

Author:

G. K. LLOYD, M. P. LIGGETT, S. R. KYNOCH and R. E. DAVIES

Year:

1977

Bibliographic source:

Fd Cosmet. Toxicol. Vol. 15, pp. 607-610. 1977.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-nitro-p-phenylenediamine

EC Number:

226-164-5

EC Name:

2-nitro-p-phenylenediamine

Cas Number:

5307-14-2

Molecular formula:

C6H7N3O2

IUPAC Name:

2-nitrobenzene-1,4-diamine

Details on test material:

- Name of test material (as cited in study report):2 nitro p phenylene diamine - Substance type:Organic - Physical state:Solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.

Controls:

other: Other eye acted as control in all the groups

Amount / concentration applied:

2.5%(w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.

Duration of treatment / exposure:

10 seconds

Observation period (in vivo):

No data

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Categorized as + or - according to whether extrapolation of the result would be expected to give a positive or negative test for eye irritation based on the definition in the Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).REMOVAL OF TEST SUBSTANCEWashing (if done): 50 ml of lukewarm water (37°C) Time after start of exposure: 10 seconds after instillation

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hrs

Reversibility:

fully reversible

Remarks on result:

other: occasional transient mild conjunctival inflammation

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.Thus, the substance is considered to be non irritating to eyes.

Executive summary:

The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.

 

The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42). 2 nitro p phenylenediamine was prepared as a 2.5% (w/v) solution or suspension. (Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na₂SO₃). Eleven groups of three rabbits were used to test solutions, each of which was instilled into one eye of each of three rabbits.

 

None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.

 

Thus, the substance is consudered to be non irritating to eyes.