4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April/May 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Remarks:

but parallel running acute oral study was conducted under GLP

Test material

Test material information

Constituent 1

Reference substance name:

4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt

EC Number:

303-161-8

EC Name:

4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt

Cas Number:

94158-87-9

Molecular formula:

C22H(27-x)N3NaxO14S3 x<=2 C22H27N3O14S3.xNa

IUPAC Name:

4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt

Test material form:

solid: particulate/powder

Details on test material:

Reactive Yellow 160

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2 - 3 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Water: deionized (ad libitum)
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 To: 15. April 1983

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Remarks:

pasted with 0.35 mL

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after removal of the adhesive dressing

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 cm²
- % coverage:
- Type of wrap if used: gauze and semi-occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): -
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30 to 60 min, 24, 48, 72 hours after removal of the adhesive dressing

SCORING SYSTEM: Draize
- Method of calculation: mean of 24, 48, 72 hour observations for each animal

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema 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:

There was sloght reddening in two animals 30 to 60 min after test substance removal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

A study was conducted to determine the in vivo skin irritation potential of the test substance according OECD Guideline 404 and EU Method B.4. Three rabbits (New-Zealand White) were exposed to 500 mg of the test substance for 4 h. The type of coverage was semi-occlusive, realised on shaved dorsal skin. The observation period was 72 h post-exposure. No erythema, edema or eschar formation was noted in any of the animals. Under the study conditions, the test substance was determined to be not irritating to rabbit skin.