4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzeneaminium, 3-[(4-amino-2,5-dimethoxyphenyl)azo]-N,N,N-trimethyl, chloride

Cas Number:

226940-14-3

Molecular formula:

C17H23N4O2Cl

IUPAC Name:

Benzeneaminium, 3-[(4-amino-2,5-dimethoxyphenyl)azo]-N,N,N-trimethyl, chloride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test substance: Basic Orange 69, 2% solution
Batch: 07 08 58101

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 females, 5 males

Administration / exposure

Vehicle:

not specified

Details on dermal exposure:

Female (body weight 214.6 – 225.2 g) and male (body weight 224.4 – 245.6 g) Sprague-
Dawley albino rats were dermally administered 2000 mg Basic Orange 69 per kg body
weight. The test substance was applied uniformly to a healthy, intact and clipped skin
surface over an area which was not less than 10% of the total body surface (about 45 cm2).
The experimental area was then covered with a porous gauze dressing held in place with a
non-irritating tape for 24 ± 1 h. At the end of the exposure period test element was
removed. Animals were observed for clinical signs during the 30 minutes following
application, 1h, 2h, 3h, 4h, 5h and 6h after administration and then at least once a day for
a total of 14 days. All animals were necropsied at the end of the observation period.

Duration of exposure:

14 days

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks:

Basic Orange 69, 2% solution

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No deaths occurred.

Clinical signs:

other: Animals were slightly excited after treatment.

Body weight:

other body weight observations

Remarks:

In females losses of weight occurred in two cases and body weight gain seemed to be low compared to males.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths occurred. Animals were slightly excited after treatment. Effects reported were
porphyrine round muzzle and orange coloured skin in both sexes. In females losses of
weight occurred in two cases and body weight gain seemed to be low compared to males.
However, no data for control animals are submitted. It was concluded that the LD50 is >
2000 mg/kg bw.