2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 401 and in accordance with the Principles of Good Laboratiory Practices (GLP).

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

EC Number:

296-120-8

EC Name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Cas Number:

92257-31-3

Molecular formula:

Not applicable

IUPAC Name:

2-​Naphthalenol, 1-​[2-​[4-​(2-​phenyldiazenyl)​phenyl]​diazenyl]​-​, ar-​heptyl ar',​ar''-​Me derivatives *

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-Source: Charles River Breeding Laboratories Inc., Wimington, Mass.
-Age at initiation: Young adult
-Identification Color coded cage tag
-Housing: Animals will be individually housed in wire mesh bottom cages when placed on study
-Food: NIH open formula 07, certified feed (Zeigler, Bro., Gardeners, PA), ad libitum. Food will be withheld the night prior to dosing.
-Water: Tap water, ad libitum.
-Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
-All environmental conditions controlled as per "Guide for the Care and Use of Laboratory Animals"
-Air Changes (per hour): 12-15 air changes/hour
-Photoperiod (hrs dark/hrs light): 12 hours light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Test Article Preparation Data
-Concentration Prepared: 50% w/v
-Diluent: Corn Oil
-Prepared Physical State: Slurry

Preperation Procedures:
-Weighted 20gm test article, Q.S. to 40ml with diluent (Corn oil)

Doses:

Animals were fasted overnight (approximately 18 hours) prior to receiving a single oral dose of 5.0g/kg of the test article prepared as described previously. The test article was administered at a constant concentration.

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?): All animals were observed for at least 14 days or until all signs of reversible toxicity subsided wihichever occurred later. They were observed three times a day on the day of dosing and twice daily for the remainder of the study.
- Frequency of weighing: Body weights were recorded initially and on days 8 and 15 or at death.
- Necropsy of survivors performed: yes, All animals that died, and all survivors that were sacrificed at termination of the study were subjected to a gross necropsy. All abnormalities were recorded.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All gross or visible toxic or pharmacological effects were recorded.

Statistics:

Mean initial, day 8 and day 15 body weights were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

95% CL:

0 - 27

Mortality:

No mortality was observed in any of the rats treated at the dose level of 5g Automate Red B Nonvolatile/kg body weight.

Clinical signs:

other: Decreased activity was observed in 5 males and 3 females. Soft stool was observed in 3 males. There were no other observations noted.

Gross pathology:

There were no noteworthy findings for males or females.

Other findings:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of this study indicates that the LD50 is greater than 5.0g/kg of body weight in both male and female Sprague-Dawley rats.

Executive summary:

The acute toxicity potential of of the test material was evaluated in both male and female Sprague Dawley rats, study methodology followed was equivalent to similar to OECD TG 401 and in accordance with the Principles of Good Laboratory practice (GLP) and under the conditions of the study, the LD50 in SD rats (combined sexes) was greater than 5.0 g/kg with 95% confidence limits ranging between 0 -27%.