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Description of key information

Skin Irritation:

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).

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.

Eye Irritation:

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.

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.

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data available
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.
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

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

 

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
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
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available
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)
Other effects / acceptance of results:
no data available
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Various studies for the target substance were summarized as follows:

Primary skin irritation test of 1-(phenylazo)-2-napthol in rabbits was performed (BASF Aktiengesellschaft Gewerbehygiene und Toxikologie, 6700 Ludwigshafen, 1977) 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 scarified 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.

The open patch test for primary irritation of 1-phenylazo-2-naphthol was conducted (Contact dermatitis, Vol.89, No.6, December 1987) with 10 albino guinea pigs. 5% concentration in ethanol was applied once daily for 4 days. Skin reaction was evaluated 24 hr and 25 days after the last application. No irritation was observed on skin of guinea pigs. Therefore,1-phenylazo-2-naphthol was considered as nonirritant to guinea pigs in the primary irritation phase.

The dermal irritation potential of 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) was estimated using OECD QSAR toolbox v3.4.

1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) was estimated to be not irritating to the skin of New Zealand White rabbits.

The test for primary irritation was conducted (OTS0556351, E I DUPONT DE NEMOURS &. CO, 1992) by applying, and lightly rubbing in one drop (approx 0.05ml) of H-8575 ( Oil orange15% AI (1-phenylazo-2-naphthol)) as supplied and a 50% solution (vol/vol) of the H-8575( Oil orange15% AI (1-phenylazo-2-naphthol)) in water on the shaved intact shoulder skin of 10 male Albino guinea pigs. The skin reactions were observed and graded at 24 and 48 hours. Oil orange 15% AI (1-phenylazo-2-naphthol) produces no irritation in the primary irritation phase of this test when tested on the shaved intact skin of male Albino guinea pig at a concentration up to (0.05ml) 100% in water (test material as supplied).

 

Hence 1-phenylazo-2-naphthol can be considered as not irritating to guinea pig skin.

Based on the information available for the target substance, it can be considered that 1-phenylazo-2-naphthol (also known as C.I Solvent Yellow 14) is not likely to cause any dermal irritation. Hence 1-phenylazo-2-naphthol (also known as C.I Solvent Yellow 14) can be evaluated as a “Non Irritant” to skin.

 

Eye Irritation: 

Various studies for the target and read across substances were summarized as follows:

Primary eye irritation of 1-(phenylazo)-2-napthol was evaluated (BASF Aktiengesellschaft Gewerbehygiene und Toxikologie, 6700 Ludwigshafen, 1977) 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.

The ocular irritation potential of C.I Solvent Yellow 14 was estimated using OECD QSAR toolbox v3.4.

1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) was estimated to be not irritating to the eyes of Himalayan rabbits.

The acute eye irritation study of the similar substance 70879-65-1was performed (SSS has letter of access, 2012)in New Zealand White Rabbits as per the OECD- 405 Guidelines.

A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control. The eyes of the test animal were not washed for at least 24 hours following instillation of the test compound. The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days.

The test compound 70879-65-1 when applied to the eye of New Zealand white rabbits at the dose level of 0.1 gm produce slight redness and mild eye discharge after four hours of application of test compound. However, any lesions such as pannus, staining were not recorded throughout the observation period of 72 hours. Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al. was used for scoring the ocular reactions. The Modified maximum average score (MMAS) of 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs was determined to be 8.33.

Based on above results, it can be concluded that the test compound 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs (CAS:70879-65-1)was practically a non irritant when applied in the amount of 0.1 gm in the conjunctival sac of the New Zealand White rabbits.

An ocular irritation study was carried out (Scientific Committee on Cosmetology (seventh series), 1988) to assess the irritation potential of the similar substance 25956-17-6 (Allura Red AC).0.1 ml of 1.0% aqueous solution of Allura Red AC was instilled into the rabbit eyes and the effects were observed (duration not specified).0.1 ml of 1.0% aqueous solution of Allura Red AC did not any changes in rabbit eyes. Hence Allura Red AC can be considered not irritating to rabbit eyes.

Based on the available information for the target and various read across substances, 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) can be considered to be not irritating to eyes.

 

Justification for classification or non-classification

Available information for 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) indicates that it is not likely to cause any irritation to eyes and skin.

Hence, 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) can be evaluated as “Non - Irritant” to eyes and skin and it can be classified under the category “Not Classified” as per CLP regulation.

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