Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, guideline-conform study report. non GLP, aqueous formulation tested

Remarks:

The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

8-day observation period

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 1

IUPAC Name:

Similar Substance 1

Specific details on test material used for the study:

38% aqueous formulation, containing also salts and oxalic acid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weights: males 2.8 kg, female 3.64 kg
One animal per cage (type: stainless steel, 40 x 51 cm); animal identification via ear tattoo.
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
A standardized animal laboratory diet (about 130 g/animal/day) and tap water (about 250 ml/animal/day) were offered.
Acclimatization period: at least 8 days before study start (same housing conditions as during the study).

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

ca. 0.5 ml (ca. 0.19 g test substance)

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3

Details on study design:

Clipping of the fur: at least 15 hours before study start
Application area: 2.5 x 2.5 cm
Applicaiton site: upper third of the dorsal and flank region
Removal of the test substance patches: after application with Lutrol and Lutrol/water (1:1)
Readins: 30 - 60 min after removal of the test patches as well as 24 h, 48 h, 72 h and 8 d after application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Time point:

other: 24-72h

Remarks on result:

not determinable

Remarks:

The substance resulted in blue staining of the skin which interfered with scoring

Irritant / corrosive response data:

Erythema value not readible due to substance-coloured skin. In two animals, staining resolved within 8 days. In the other animal, stiaining was still visible after 8 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An aqueous formulation containing 38% of the substance is not irritating to skin.