1-Naphthalenesulfonic acid, 6-diazo-5,6-dihydro-5-oxo-, ester with phenyl(2,3,4-trihydroxyphenyl)methanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

18 - 21 Aug 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Different evaluation criteria than in TG OECD 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline followed

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Principles of method if other than guideline:

internal guideline Hoechst AG

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-Naphthalenesulfonic acid, 6-diazo-5,6-dihydro-5-oxo-, ester with phenyl(2,3,4-trihydroxyphenyl)methanone

EC Number:

270-931-7

EC Name:

1-Naphthalenesulfonic acid, 6-diazo-5,6-dihydro-5-oxo-, ester with phenyl(2,3,4-trihydroxyphenyl)methanone

Cas Number:

68510-93-0

Molecular formula:

all potential esters of C10HH5O3N2SCl and C13H10O4

IUPAC Name:

3-benzoyl-2-hydroxy-6-({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl 5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalene-1-sulfonate; 4-benzoyl-2,3-bis({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl 5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalene-1-sulfonate; 4-benzoyl-2,3-dihydroxyphenyl 5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalene-1-sulfonate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding (Hoechst Aktiengesellschaft, Pharma Forschung, Toxikologie, Germany)
- Weight at study initiation: 2.3 - 3.3 kg
- Housing: individual
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf., Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

other: physiological NaCl solution (0.5 mL)

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: The test item was applied onto a surgical gauze pad (Hansamed Wundpflaster). The test item and gauze pad were then covered with an impermeable polyethylene foil (width: 6 - 8 cm). The entire trunk of each animal was then encased in an elastic wrapping (polyurethan-warp thread bandage (Dauerbinde K)).

OBSERVATION TIME POINTS
24, 48 and 72 h after dosing

SCORING SYSTEM: according to §1500.41 of the Federal Register 38, No. 187, 27.9.1973, p 27019 (comparable to Draize scoring system)
- Method of calculation: The skin irritation index was calculated per animal. The erythema and edema scores after 24 and 72 h were added for the intact and abraded skin. Finally the sum of the scores of
all animals was divided through the amount of animals and through 4.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

2.7

Max. score:

8

Reversibility:

not specified

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Available data of this study cannot be used for the classification regarding skin irritation/corrosion. With respect to the result of the in vitro study (reference 7.3.1-2) and the slight irritating effect observed in this study, the registrant decided - based on a worst case assumption - to classify the test substance as Skin irrit. 2 (H315) according to Regulation (EC) 1272/2008.