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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73.
Principles of method if other than guideline:
Primary eye irritation of 1-(phenylazo)-2-napthol was evaluated in rabbits according to Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73. Guidelines
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-phenylazo-2-naphthol
EC Number:
212-668-2
EC Name:
1-phenylazo-2-naphthol
Cas Number:
842-07-9
Molecular formula:
C16H12N2O
IUPAC Name:
1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol
Test material form:
solid
Details on test material:
Name of test material (as cited in study report): C.I Solvent Yellow 14
Molecular formula: C16H12N2O
Molecular weight:248.284 g/mol
Smiles notation :c12c(\N=N\c3ccccc3)c(ccc1cccc2)O
InChl:1S/C16H12N2O/c1915111012645914(12)16(15)1817137213813/h111,19H/b1817+
Physical State: Solid
Substance type: Organic
Specific details on test material used for the study:
Name of test material (as cited in study report): C.I Solvent Yellow 14
Molecular formula: C16H12N2O
Molecular weight: 248.284 g/mol
Smiles notation: c12c(\N=N\c3ccccc3)c(ccc1cccc2)O
InChI: 1S/C16H12N2O/c1915111012645914(12)16(15)1817137213813/h111,19H/b1817+
Physical State: Solid
Substance type: Organic

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
no data available
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24, 48 and 72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
The test chemical was instilled into the right eye of the rabbits
Scoring method: Draize, J .H. (1959)

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
1.34
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Conjunctival redness and secretion was observed in all the rabbits till 72 hours.

Any other information on results incl. tables

Results of Primary Eye Irritation test:

 

 

24 hours

48 hours

72 hours

Right Eye

Rabbit number

Rabbit number

Rabbit number

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

1.      Cornea

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A.     Cloudiness

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

B.     Area

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

a= A*B*5 (Max =50)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2.      Iris

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

b= Wert*5 (Max = 10)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3.      Conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A.     Redness

1

1

1

0

1

1

1

1

0

0

1

1

0

1

1

0

1

0

B.     Swelling

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

C.     Secretion

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

c= (A+B+C)*2 (Max = 20)

2

2

2

0

2

2

2

2

0

0

2

2

0

2

2

0

2

0

Total = a + b+ c (Max = 110)

2

2

2

0

2

2

2

2

0

0

2

2

0

2

2

0

2

0

Primary Eye Irritation Score : φ18 = 1.34

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Primary Irritation Score for eye irritation in rabbits was 1.34.
Based on the scores, 1-(phenylazo)-2-napthol can be considered as not irritating to rabbit eyes.
Executive summary:

Primary eye irritation of 1-(phenylazo)-2-napthol  was evaluated in rabbits according to Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73. Guidelines.

6 rabbits were used for the study.Undiluted test chemical was instilled into the right eye of the rabbit and the effects were observed.The reactions were observed at 24 ,48 and 72 hours and scored according to Draize method.Conjunctival redness and secretion was observed in all the rabbits till 72 hours.

The Primary Irritation Score for eye irritation in rabbits was 1.34.

Based on the scores, 1-(phenylazo)-2-napthol  can be considered as not irritating to rabbit eyes.

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