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

Eye irritation

Administrative data

Endpoint:

eye 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 than in TG OECD 405

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2012

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: FDA, Federal Register 38, No. 187, 1973

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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

Vehicle:

other: physiological NaCl solution (0.1 mL)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: classification according to "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" FDA, Austin, Texas, p 51, 1975 (for further details refer to section "any other information on materials and methods incl. tables")
- Method of calculation: The eye irritation index was calculated per animal by summing up the different scores for cornea opacity, iris and conjuctivae 1, 7, 24, 48 and 72 h after application. Finally the mean index of all animals was calculated and the highest index (out of the different time points) was chosen for classification.

TOOL USED TO ASSESS SCORE: magnifier / fluorescein sodium (0.01%)

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 h

Score:

8

Max. score:

110

Reversibility:

not specified

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

CLP: based on the available data, no classification is possible according to Regulation (EC) No 1272/2008. A conclusion regarding the classification or non-classification can only be made in combination with additional data.