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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1969

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study is considered to be reliability 3 since it was performed at Industrial Biotest Laboratories prior to the implementation of GLP and during a time period where the conduct, quality and reliability of studies performed at this lab was brought into question. The study may have been performed in a satisfactory manner but insufficient information is available to allow a complete audit to verify the quality and reliability.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

No specific guideline referenced, however, methods of study were well documented (see details on dermal exposure and study design in methods description).

GLP compliance:

no

Remarks:

Study conducted prior to GLP's.

Test type:

other:

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:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

The test material remained in contact with the skin for 24 hours.

Doses:

On the testing day, the rabbits received skin applications of the undiluted test material at dose levels of 6.8 and 10.2 g/kg.

No. of animals per sex per dose:

A group of four rahbits (two male and two femaJe) was tested at each level.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 200 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test material in male and female New Zealand White Rabbits was determined to be > 10.2 g/kg.

Executive summary:

The acute dermal toxicity potential of the test material 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 in male and female New Zealand White Rabbits was determined to be > 10.2 g/kg.