1-(2,4-dimethylphenylazo)-2-naphthol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

data fis rom peer-reviewed journal

Data source

Reference

Reference 1

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 2

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:

no guideline available

Principles of method if other than guideline:

Acute dermal toxicity study of Solvent Red 1 in rabbit was determined.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-[(2-methoxyphenyl)azo]-2-naphthol

EC Number:

214-968-9

EC Name:

1-[(2-methoxyphenyl)azo]-2-naphthol

Cas Number:

1229-55-6

Molecular formula:

C17H14N2O2

IUPAC Name:

1-[(2-methoxyphenyl)azo]-2-naphthol

Details on test material:

Name of test material : 1-[(2-methoxyphenyl)azo]-2-naphthol
Molecular Formula : C17H14N2O2
Substance Type : Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):Solvent Red 1
- Molecular formula :C17H14N2O2
- Molecular weight :278.31 g/mole
- Substance type:Organic
- Physical state:Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper’s rabbit ranch, Gary, IN.
- Age at study initiation: No data available
- Weight at study initiation: 2.14 – 2.84 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: September 12, 1985 To: September 26, 1985

Administration / exposure

Type of coverage:

other: Dermal

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and lateral trunk
- % coverage: approximately 10% of the body surface area
- Type of wrap if used: plastic wrap and stockinette were used.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, by Each application 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: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg/kg bw
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rabbits

Control animals:

yes, concurrent vehicle

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days (or other?): 14 days
- Frequency of observations and weighing: Mortality once daily and body weight on day 0, 3, 7, 10 and prior to sacrifice on day 14, or at the time animal found dead.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: clinical signs, gross pathology and histopathology were performed.

Statistics:

The mean, standard deviation, and standard error were calculated for the body weight data and for the amount of test substance applied. The approximate amount of test article applied was calculated in milligrams per square centimeter of exposed skin.

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality were observed in treated rabbits.

Clinical signs:

other: Red stain on teat site, feet and head discolored red in treated male and female rabbits. Few stools and loose stool were observed in treated male rabbits.

Gross pathology:

Red discoloration of treated skin, red discoloration of fur, a liver with a dark red discoloration, and 2 lungs with red discoloration was observed in treated male and female rabbits.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be > 2000 mg/kg bw when New Zealand White male and female rabbits were treated with Solvent Red 1 (1-[(2-methoxy phenyl)diazenyl]-2-naphthol) by dermal application for 24 hours.

Executive summary:

In acute dermal toxicity study, New Zealand White male and female rabbits were treated with Solvent Red 1 (1-[(2-methoxyphenyl)diazenyl]-2-naphthol) in the concentration of 5000 mg/kg bw in physiological saline applied on dorsal and lateral trunk (approximately 10% of the body surface area) of each animal was clipped free of hair with Oster electric clippers equipped with a number 40 (surgical) blade for 24 hours. No mortality was observed in treated rabbits. Red stain on teat site, feet and head discolored red in treated male and female rabbits. Few stools and loose stool were observed in treated male rabbits. Gained overall body weight was observed in treated male and female rabbits. Red discoloration of treated skin, red discoloration of fur, a liver with a dark red discoloration, and 2 lungs with red discoloration was observed in treated male and female rabbits. Therefore, LD50 was considered to be > 2000 mg/kg bw when New Zealand White male and female rabbits were treated with Solvent Red 1 (1-[(2-methoxyphenyl)diazenyl]-2-naphthol) by dermal application for 24 hours.