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

Endpoint summary

Description of key information

One acute oral toxicity study of high reliability. one acute oral and one acute dermal toxicity study of low reliability.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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).

Reason / purpose for cross-reference:

reference to other study

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

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

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.

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

none

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%.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

acceptable for assessment

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute Oral toxicity:

The acute toxicity potential of the test substance 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 of the test substance in SD rats (combined sexes) was greater than 5.0 g/kg with 95% confidence limits ranging between 0 -27%.

Acute Dermal toxicity:

No reliable acute dermal toxicity studies are available for this substance. A study on a product containing the REACH substance as well as a solvent was performed at the Industrial Biotest laboratory prior to the introduction of GLP. Due to the concerns with data generated by that laboratory this study is consedered to be low reliability. However it does indicate that the substance has a low order of dermal toxicity and this is consistent with the acute oral toxicity data. Consequently it is justified to wiave the acute dermal toxicity study.

A summary of the acute dermal toxicity study is below:

The acute dermal toxicity potential of the test substance was evaluated in both male and female New Zealand White rabbits. 2 males and 2 females per dose group were dosed with either 6.8 or 10.2 g/kg of test material. There were no deaths in either dose groups. No untoward behavioral reactions were noted among any of the animals. Wrinkling of the skin at the application site was noted among animals in both groups by the seventh day of the l4-day observation period. By the end of the 14-day observation period escharosis was noted. The red color of the test material precluded evaluation of

the skin at the application site for erythema. No gross pathologic alterations were noted among any of the animals other than the dermal alterations previously described. The acute dermal LD50 of the test material in male and female New Zealand White Rabbits was determined to be > 10.2 g/kg

Justification for selection of acute toxicity – oral endpoint
Reliable study, equivalent to an OECD guideline study, conducted according to GLP

Justification for classification or non-classification

The Oral LD50 is greater than 2000 mg/kg bw and the available dermal toxicity data do not indicate any acute toxicity via this route. Based on these data this substance does not meet the criteria for classification for acute toxicity.