trisodium bis[3-[1-(3-chlorophenyl)-5-(hydroxykO)-3-methyl-1H-pyrazol-4-yl]diazenyl}-4-(hydroxy-kO)5-nitrobenzenesulfonato(3-)]chromate(3-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Red 423

IUPAC Name:

Acid Red 423

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

An area of at least 6 cm2 was shaved on both flanks of the animals approx. 24 hours before treatmnet.
0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad (20 cm2).
This were covered with aluminium foil (36 mm2) and then covered with an occlusive dressing for 4 hours.
The dressing was wrapped with an adhesive tape (isoplast AG, CH).

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours and for other 7 days

Number of animals:

3 male rabbits

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Reversibility:

no data

Results 2

Irritation parameter:

edema score

Basis:

other: mean of all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Reversibility:

no data

Irritant / corrosive response data:

No irritation effect observed on all animals.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

Coloration: in the area of application a clear visible red stained of the test skin was observed in animals 76 and 77 up to 48 hours and in animal 75 up to 72 hours which could be related to effects of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

OECD GHS

Conclusions:

Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.

Executive summary:

The primary irritation score was assessed following OECD 404.

The results show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under Regulation EC 1272/2008 .