1-phenylazo-2-naphthol

Skin irritation / corrosion

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

Test material information

Constituent 1

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.