6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 05, 1996 - November 26, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

07-1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

07-1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride

EC Number:

223-211-1

EC Name:

6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride

Cas Number:

3770-97-6

Molecular formula:

C10H5ClN2O3S

IUPAC Name:

6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-2-sulfonyl chloride

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb:NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.9 - 3.1 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: sesame oil

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

Up to 14 days

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Administration of the test substance and exposure period was performed under protection from light.
Each animal was treated with 500 mg of the test item pasted with 0.6 mL sesame oil. The substance was applied over the whole surface of a 2.5*2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because of persistent irritations in one animal 72 hours after removal of the patches, additional readings were performed in this animal after 7 and 14 days.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

30 - 60 minutes up to one day after removal of the patches the skin of the animals showed very slight to moderate erythema and a very slight oedema. Two days after removal of the patches the signs of irritation were reversible in two animals. The third animal still exhibited well-defined to moderate erythema up to 7 days after application. 14 days after application the signs of irritation were reversible in the animal. Additionally 30 - 60 minutes up to 3 days after removal of the patches the skin of the animals was discoloured light yellow.

Any other information on results incl. tables

Study design

The purpose of this GLP study performed according to OECD GL 404 was to assess the irritancy potential of the test item to the skin of the New Zealand White rabbits.

Results

30 - 60 minutes up to one day after removal of the patches the skin of the animals showed very slight to moderate erythema and a very slight oedema. Two days after removal of the patches the signs of irritation were reversible in two animals. The third animal still exhibited well-defined to moderate erythema up to 7 days after application. 14 days after application the signs of irritation were reversible in the animal. Additionally 30 - 60 minutes up to 3 days after removal of the patches the skin of the animals was discoloured light yellow.

Conclusion

The test material gave no indication for a skin irritation potential when tested in NZW rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material gave no indication for a skin irritation potential when tested in NZW rabbits.

Executive summary:

This study was performed according to GLP and is fully compliant with OECD GL 404. Based on the results of this study it was concluded that the test item is not irritant to the rabbit skin.