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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 No 187 § 1500 .41 (skin)
Principles of method if other than guideline:
Primary skin irritation test of 1-(Phenylazo)2-Napthol in rabbits according to Guidelines mentioned in Federal Register 38 No 187 § 1500 .41 (skin)
GLP compliance:
no

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
Details on test material:
- Name of test material (as cited in study report): 1-phenylazo-2-naphthol
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Substance type: Organic
- Physical state: solid
Purity No data available
- Impurities (identity and concentrations): No data available
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

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

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and scarified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
50% in aqueous solution
Duration of treatment / exposure:
72 hours
Observation period:
24 hours and 72 hours
Number of animals:
6
Details on study design:
SCORING SYSTEM:
Draize, J .H. (1959): Dermal Toxicity. In : FDA-Appraisal of the Safety of Chemicals in Foods, Drugs And Cosmetics.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.17
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Due to substance-induced coloration of the skin no reading and no exact calculation of the primary irritation possible at 24 hours
Other effects:
No data available

Any other information on results incl. tables

Results of the Primary Skin Irritation Study:

 

time

Irritation

Average Value

Total Value

Animal no.

1

2

3

4

5

6

 

 

1.      Skin reddening / corrosive

 

 

 

 

 

 

 

 

 

Intact

 

24 h

*

*

*

*

*

*

-

-

72 h

-

0

0

*

*

*

0

0

Scarified

 

24 h

*

*

*

*

*

*

-

-

72 h

0

0

0

*

*

*

0

0

2.      Edema formation

 

 

 

 

 

 

 

 

 

Intact

 

24 h

0

0

0

0

0

0

0

0

72 h

0

0

0

0

0

0

0

0

Scarified

24 h

2

2

0

0

0

0

4

0.67

72 h

0

0

0

0

0

0

0

0

Primary Irritation of the skin: 0.67/4 = 0.17

*- Due to substance-induced coloration of the skin, no reading and exact calculation of the primary irritation was possible.

 

 

Skin Lesions after 8 days

 

Animal No

Intact

Scarified

1

0

0

2

0

Dandruff formation

3

0

Dandruff formation

4

0

Dandruff formation

5

0

0

6

0

Dandruff formation

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Primary Skin Irritation Score of 1-phenylazo-2-naphthol was 0.17.
On the basis of the scores and observations, 1-phenylazo-2-napthol can be considered as not irritating to skin.
Executive summary:

Primary skin irritation test of 1-(phenylazo)-2-napthol in rabbits was performed according to Guidelines mentioned in Federal Register 38 No 187 § 1500 .41 (skin).

6 rabbits were used for the study. 50% of the substance in aqueous solution was applied on the intact and scarfied skin of rabbits and the effects were observed at 24 and 72 hours.The reactions were scored according to Draize method.Due to substance-induced coloration of the skin no reading and no exact calculation of the primary irritation was possible at 24 hours.

Skin lesions were also observed after 8 days of testing.No lesions were observed in case of intact skin , but dandruff formation was recorded in 4 of 6 rabbits in case of scarified skin.

The Primary Skin Irritation Score of 1-phenylazo-2-naphthol was 0.17.

On the basis of the scores and observations, 1-phenylazo-2-napthol can be considered as not irritating to skin.

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