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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:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

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: Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).
Principles of method if other than guideline:
To assess the ocular irritancy potential of the test chemical in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): 2-amino-4-nitrophenol
- Molecular Formula: C6H6N2O3
- Molecular Weight: 154.125 g/mol
- SMILES Notation: C1=CC(=C(C=C1[N+](=O)[O-])N)O
- InChI: 1S/C6H6N2O3/c7-5-3-4(8(10)11)1-2-6(5)9/h1-3,9H,7H2
- 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:
yes, concurrent no treatment
Amount / concentration applied:
2.5%(w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1, 24 hours
Duration of post- treatment incubation (in vitro):
no data available
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 SUBSTANCE
Washing (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: 1 hours
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Treatment with the test chemical gave rise to a yellow coloration of the cornea 1 hr after instillation, but the cornea was clear by the 24-hr reading, and there was no observable irritant response in any of the animals in this group.
According to the Code of Federal Regulations, Test for Eye Irritants, the test chemical was scored as ± ,.

Any other information on results incl. tables

Table: Results of the skin and eye irritancy studies on rabbits

Compound

Skin Irritation

(Primary Irritation Index)

Eye Irritation **

99 -57 -0

0

±

**Categorized as + or - according to whether extrapolation of the result would be expected to give a positive or negative in the Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).

                                                  

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The irritant effects on rabbit eye mucosa, was assessed for the test chemical.Treatment with the test chemical gave rise to a yellow coloration of the cornea 1 hr after instillation, but the cornea was clear by the 24-hr reading, and there was no observable irritant response in any of the animals in this group.
According to the Code of Federal Regulations, Test for Eye Irritants, the test chemical was scored as ± .
Based on the scores and observations, the test chemical can be considered to be not irritating to eyes.
Executive summary:

The irritant effects on rabbit eye mucosa, was assessed for the test chemical.

 

The procedure for the eye tests was also based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42).The test chemical 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. The eyes of all the rabbits were irrigated with 50 ml of lukewarm (37°C) water, 10 sec after instillation of the test material.

Treatment with the test chemical gave rise to a yellow coloration of the cornea 1 hr after instillation, but the cornea was clear by the 24-hr reading, and there was no observable irritant response in any of the animals in this group.

According to the Code of Federal Regulations, Test for Eye Irritants, the test chemical was scored as ± .

Based on the scores and observations, the test chemical can be considered to be not irritating to eyes.