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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:
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

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity Evaluation of Solvent Red 1
Author:
Gunda Reddy and Dale A. Mayhew
Year:
1996
Bibliographic source:
International Journal of Toxicology Vol 15, Issue 1_suppl, pp. S43 - S44, 1996
Reference Type:
secondary source
Title:
Dermal, Eye and Oral toxicological evaluations, phase IV report with Disperse Red 11, Disperse Blue 3, Solvent Red 1 and Red and Violet Mixtures.
Author:
U.S. Army Medical Bioengineering Research and development Laboratory
Year:
1986
Bibliographic source:
NTRL- April - 1986, Page no 1-169.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of Solvent Red 1 in New Zealand White rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : 1-[(2-methoxyphenyl)diazenyl]-2-naphthol
- Common Name: Solvent Red 1
- Molecular formula : C17H14N2O2
- Molecular weight : 278.31 g/mol
- Smiles notation : c12c(\N=N\c3c(cccc3)OC)c(ccc1cccc2)O
- InChl : 1S/C17H14N2O2/c1-21-16-9-5-4-8-14(16)18-19-17-13-7-3-2-6-12(13)10-11-15(17)20/h2-11,20H,1H3/b19-18+
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of test material: 1-[(2-methoxyphenyl)diazenyl]-2-naphthol
- Common Name: Solvent Red 1
- Molecular formula: C17H14N2O2
- Molecular weight: 278.31 g/mol
- Smiles notation: c12c(\N=N\c3c(cccc3)OC)c(ccc1cccc2)O
- InChl : 1S/C17H14N2O2/c1-21-16-9-5-4-8-14(16)18-19-17-13-7-3-2-6-12(13)10-11-15(17)20/h2-11,20H,1H3/b19-18+
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Sex: Male and female
- Source: Kuiper’s rabbit ranch, Gary, IN.
- Age at study initiation: No data available
- Weight at study initiation: 2.26 – 2.88 kg
- Fasting period before study: No data available
- Housing: Animals were housed in the appropriate randomly selected cage. Each animal was then assigned a sequential animal number unique within American Biogenics Corporation (ABC) and identified with an ear tag bearing this animal number, The sequential animal number was listed on a cage card that was affixed to the front of the animal's cage. Rooms were cleaned daily and the cages were cleaned and sanitized as specified in ABC SOP's. Urine and feces fell through the wire mesh floor onto animal caging board. The cage boards were changed at least 2 to 3 times per week.
- Diet (e.g. ad libitum): Purina Certified Rodent Chow 5002, ad libitum, except for fasting prior to dosing.

- Water (e.g. ad libitum): Filtered tap water was provided through an automatic watering system and was analyzed periodically, ad libitum.

- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 7 °C
- Humidity (%): 30-70 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 6:00 a.m. to 6:00 p.m. (12 hour light/dark, cycle)

IN-LIFE DATES: From: October 15, 1985 To: October 29, 1985

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and abraded skin
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
Each rabbit received a dose of 0.5ml Solvent Red 1 on two intact sites and two abraded sites (the right anterior and the left posterior were abraded).
Duration of treatment / exposure:
24 hours
Observation period:
Sites were scored at 24 and 72 hr. after application
Number of animals:
groups of 6 rabbits (3/sex)
Details on study design:
TEST SITE
- Area of exposure: Thoracic region of spinal column
- % coverage: No data available
- Type of wrap if used: 2.5 centimeter square gauze patch were used.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Each test site was gently wiped with gauze sponges moistened with an appropriate vehicle (known not to cause any dermal toxic reactions) to remove any remaining test article.
- Time after start of exposure: 24 hours

SCORING SYSTEM: The reactions were scored according to the method of Draize
The Primary Irritation Score was calculated for each test article as follows: the average scores for erythema and eschar formation for intact and abraded skin at 24 (+2) and 72 (+2) hours were added to the average scores for edema for intact and abraded skin at 24 (+2) and 72 (+2) hours. The total of the 16 values was divided by 8 to give the Primary Irritation Score.

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No mortalities or abnormal clinical signs were observed during the study. No dermal irritation was observed during the study. Solvent Red 1 scored 0.0 on the Primary Irritation Index. Solvent Red 1 was non-irritating.

Any other information on results incl. tables

Table: Primary Dermal Irritation of Solvent Red 1

 

Animal Number

Sex

Initial Body Weight (kg)

24(+2) hours**

 

72(+2) hours**

Intact

Abraded

Intact

Abraded

Left

Right

Left

Right

Left

Right

Left

 

Right

 

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

ed

BB9374

Male

2.56

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

BB9375

Male

2.86

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

BB9422

Male

2.86

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

BB9403

Female

3.10

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

BB9439

Female

2.74

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

BB9449

Female

2.60

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

0r

0

Total

 

 

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Average

 

 

(A)

0

(B)

0

(C)

0

(D)

0

 

(E)

0

(F)

0

 

(G)

0

(H)

0

(I)

0

(J)

0

(K)

0

(L)

0

(M)

0

(N)

0

(O)

0

(P)

0

 

**= after test article application

Er= erythema

Ed= edema

R= test site stained red

Primary Irritation Score = (A+B+C+D+E+F+G+H+I+J+K+L+M+N+O+P)/8

 Primary Irritation Score = 0.0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No mortalities or abnormal clinical signs were observed during the study. No dermal irritation was observed during the study. Solvent Red 1 scored 0.0 on the Primary Irritation Index. Hence, Solvent Red 1 was considered to be not irritating to rabbit skin.
Executive summary:

The primary dermal irritation of Solvent Red 1 was assessed in rabbits. The backs of six New Zealand White (NZW) rabbits (three of each sex) were closely clipped 24 hours before dosing. Each rabbit received a dose of 0.5ml Solvent Red 1 on two intact sites and two abraded sites (the right anterior and the left posterior were abraded). After 24 hours of exposure, the wrappings and patches were removed and sites wiped off with gauze sponges moistened with water. Sites were scored at 24 and 72 hours after application using the method of Draize (1979).Each animal was weighed prior to application of each test article. All animals were observed at least once daily for mortality and obvious toxic signs.

No mortalities or abnormal clinical signs were observed during the study. No dermal irritation was observed during the study. Solvent Red 1 scored 0.0 on the Primary Irritation Index. Hence, Solvent Red 1 was considered to be not irritating to rabbit skin.