Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5-11-1993 to 5-24-1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: All animals dosed with a single dose of 5g/kg body weight

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

EC Number:

915-586-1

Molecular formula:

Variable; substance is a UVCB.

IUPAC Name:

Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

Test material form:

other: Semi-solid

Details on test material:

The test material was a red colored semi-solid, identified as Automate Yellow 8 Petroleum. The test material was administered as a 50% w jw solution with mineral oil. Records of the test article purity, source and other data required by Federal Regulations will be maintained by the Sponsor.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female albino rats weighing between 200 and 229 grams were used for this study. The rats were obtained from Harlan Sprague Dawley, Inc., Indianapolis, Indiana. The rats used for this study were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity, and light-controlled room (room 15B). The animals were maintained according to the recommendations contained in DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for 5 days prior to initiation of the study. Except for described periods associated with dosing, Purina Rat Chow and water were available ad libitum. Animals were selected randomly from the acclimated colony and assigned to the test group.

Justification for Selection of Test System: The Sprague-Dawley rat has been used extensively as an animal model for oral toxicity testing.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: mineral oil

Details on oral exposure:

The test material was administered by oral gavage to fasted (overnight) animals (five males and five females per dose group) according to individual body weights. A dose level of 5 g/kg body weight was administered via a metal dosing cannula.

Doses:

5 g/kg body weight

No. of animals per sex per dose:

5 males and 5 females per dose group.

Control animals:

no

Details on study design:

The rats were observed for any toxic or deleterious effects at 1, 2.5, and 4 hours after dosing and then twice daily for 14 days. Animal body weights were obtained at study initiation, and at 7 and 14 days post-administration. A gross necropsy examination was performed on all animals at the end of the 14-day observation period.

Statistics:

There was no mortality observed during the course of the study. It was not necessary to calculate the LD50 or 95% Confidence Limits.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality observed during the course of the study.

Clinical signs:

other: A summary of pharmacotoxic observations is available in Table 2. The primary pharmacotoxic observations were hunched posture and loose stool, and occurred on study day 1 and 2. All animals appeared normal from study day 3 to study termination.

Gross pathology:

Individual gross necropsy observations are presented in Table 3. There were no gross changes observed in any of the animals at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of this study, the acute oral LD50 of Automate Yellow 8 Petroleum is greater than 5 g/kg body weight.

Executive summary:

Automate Yellow 8 Petroleum was administered by oral gavage to five male and five female rats at a dose level of 5 g/kg body weight. The animals were observed for pharmacotoxic signs and mortality during a 14 day observation period. A gross necropsy examination was performed on all animals at the end of the 14 day observation period.

All animals survived the study in apparent good health and exhibited normal weight gains during the study course. The primary pharmacotoxic observations were hunched posture and loose stool, and occurred during study day 1 and 2. All animals appeared normal from study day 3 until study termination. There were no gross changes observed in any of the animals at terminal necropsy.

Based upon the results of this study, the acute oral LD50 of Automate Yellow 8 Petroleum is greater than 5 g/kg body weight.