Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 23 to 26, 1986.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines and performed according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate
EC Number:
267-097-1
EC Name:
Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate
Cas Number:
67786-25-8
Molecular formula:
C44H48N12Na4O16S4
IUPAC Name:
tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[bis(2-hydroxypropyl)amino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: approx. 12 to 16 weeks old.
- Weight at study initiation: 2.38 - 2.45 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: free access, Rabbit Diet (Special Diet Services Limited, witham, Essex, U.K).
- Water: free access, driking water.
- Acclimation period: minimum five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 21 °C
- Humidity: 50 - 55 %
- Air changes: approx. 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Test system

Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of test material, moistened with 0.5 ml of distilled water.
- Application: gauze patches of 2.5 x2.5 cm laden with the test material.
Duration of treatment / exposure:
Four hours after application the corset and patches were removed.
Number of animals:
Three.
Details on study design:
TEST SITE
- Area of exposure: approximately twenty-four hours prior to the commencement of the test, each of a group of three rabbits was prepared by closely clipping the fur from the dorsal/flank areas using veterinary clippers. On the day of the test a suitable test site was selected on the back of each rabbit.
- Type of wrap if used: the patch was secured in position over the test material with two lengths of adhesive strapping (SLEEK) in the form of a cross. To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours.

SCORING SYSTEM
Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at this treated skin site at subsequent observations. The other treated skin sites appeared normal throughout the study period.

Any other information on results incl. tables

Tables of results is not available.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

Method

The skin irritation potential was tested in New Zealand White rabbits. The procedure used is described in the OECD guideline 404.

Results

Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at this treated skin site at subsequent observations. The other treated skin sites appeared normal throughout the study period.

Conclusion

The test material was found to be non-irritant to rabbit skin according to the EEC labelling Regulations and requires no symbol or risk phrase. Considering that the criteria to classify a substance according to the CLP regulation (EC 1272/2008) are similar, it can be assumed that also according to the CLP Regulation the substance is not irritating.