4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 05, 1982 to October 08, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Not conducted under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol

EC Number:

243-325-5

EC Name:

4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol

Cas Number:

19800-42-1

Molecular formula:

C19H15N5O4

IUPAC Name:

4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Body weight: 2.3 - 2.6 kg
Temperature: 22 +/- 2°C
Humidity: 50 +/- 20%
Ligh/dark period: 12/12 hours
Feed and water: ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

physiological saline

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

0.5, 1, 24, 48 and 72 h

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At 1 h slight edema (Grade 1) and slight to moderate erythema (Grade 2) was observed. Edema was no longer visible at the 24-hour evaluation. Erythema wa completely reversed after 72 hours.

Other effects:

Discoloration was observed until 24 h.
All signs of irritation were reversible within 72 h.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was considered not irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404. The clipped dorsal flank (ca. 20 cm2) of three New-Zealand white rabbits was exposed to 500 mg test substance (in the form of a yellow-brown powder of 48% purity) for 4 h under semi-occlusive conditions. At the end of the exposure period, the treated skin area was carefully cleaned. Skin irritation/corrosion was assessed 0.5, 1, 24, 48 and 72 h after bandage removal. Erythema (Grade 2 then 1) was observed in all animals for 24 h. Only one animal still showed mild erythema (Grade 1) at 48 h and there were no further observations at 72 h. Oedema occurred in all 3 animals at the 0.5 - 1 h time point but was no longer seen after that. The overall irritation index was calculated to be 1.0, the test substance was therefore considered to be slighly irritating to rabbit skin (Jung, 1982). Under the current evaluation system, the test substance is considered as not irritating.