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Toxicological information

Eye irritation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.