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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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

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: No data
Principles of method if other than guideline:
Acute dermal toxicity study of Solvent Red 1 in rabbit.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 (if other than submission substance): C17H14N2O2
- Molecular weight (if other than submission substance): 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 and environmental conditions:
Details on test animal
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:
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.
Body weight:
Gained overall body weight were observed in treated male and female 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:
Category 5 based on GHS criteria
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-methoxyphenyl)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 ofr 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.