A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 6, 1990 to September 20, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate

EC Number:

406-870-1

EC Name:

A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate

Cas Number:

115100-55-5

Molecular formula:

not applicable

IUPAC Name:

triiron(3+) nonasodium 2-(2-{4-hydroxy-2-oxido-5-[2-(3-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate 2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-2-hydroxy-4-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate tris(2-(2-{5-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-4-hydroxy-2-oxidophenyl}diazen-1-yl)-4,6-dinitrobenzen-1-olate) 2-{2-[4-hydroxy-5-(2-{4-[(4-nitro-2-sulfophenyl)amino]phenyl}diazen-1-yl)-2-oxidophenyl]diazen-1-yl}-4,6-dinitrobenzen-1-olate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: BRL Ltd., Basel, Switzerland
-Age at study initiation: ~ 9 weeks
-Weight at study initiation:
males: 214 to 255 gram
females: 178 to 211 gram
-Housing: Individually housed in polycarbonate cages containing purified sawdust as bedding material (Woody SPF supplied by Broekman Institute, Someren, The Netherlands).
-Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland).
-Water (e.g. ad libitum): Free access to tap-water
-Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21 °C
-Humidity (%): 55 %
-Air changes (per hr): 15 air changes per hour and the environment controlled with optimal conditions
-Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x7 cm on the back
- % coverage: 25 cm² for ♂ and 18 cm² for ♀
- Type of wrap if used: gauze patch fixed successively to aluminium foil
and flexible bandage (Ceban, 3M, St, Paul, U.S.A.), with drops of petrolatum.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours, thereafter residual test substance was removed with tissue moistened with tap-water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg b.w
- Dose volume: 10 ml/kg b.w

Duration of exposure:

24 h

Doses:

2000 mg/kg b.w

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations Mortality / Viability: At periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days.
-Frequency of observationsand weighing: Test days 1 (pre-administration), 8 and 15
-Necropsy of survivors performed: yes
All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation and subjected to necropsy. All animals assigned to the study were subjected to necropsy. The necropsies were performed by experienced prosectors and descriptions of all macroscopic abnormalities recorded.

-Other examinations performed:
At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin (treated skin), fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study period.

Clinical signs:

Lethargy was noted in three animals during treatment on day 1. Throughout the study, the treated skin area of all the animals was discoloured
yellow/brown by the test substance. One male showed erythema on days 2 and 3 and 1 male showed crusts on days 4 and 5.

Body weight:

Lower than expected body weight gain was shown by the animals over the first week of the study. However, all showed improved body weight gain over the second week of the study.

Gross pathology:

Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: not classifed according to the CLP (EC 1272/2008)

Conclusions:

The dermal LD-50 value in rats of either sex was established to exceed 2000 mg/kg body weight.

Executive summary:

The purpose of this study was to assess the toxicity of the test article when administered to rats as a single dermal dose.

The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 84/449/EEC, Part B.3, "Acute Toxicity - Dermal".

The substance was dermally applied to five rats of each sex at 2000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.

No animals died during the study.

Lethargy was noted in three animals on the day of treatment (day 1) only. Lower than expected body weight gain was shown by the animals over the first week of the study. However, all showed improved body weight gain over the second week of the study.

The treated skin area of all the animals showed yellow/brown discolouration by the test substance throughout the study. One male showed erythema on days 2 and 3 and 1 male showed crusts on days 4 and 5. Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

The dermal LD-50 value in rats of either sex was established to exceed 2000 mg/kg body weight.

According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC; Annex VI of the EEC Directive 67/548/EEC), the substance cannot be classified and has no obligatory labelling requirement.