Reaction mass of trisodium [m[7-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-8-hydroxynaphthalene-1,6-disulphonato(7-)]]dicuprate(3-) and trisodium [m[4-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-3-hydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

supporting study

Study period:

From October 18th to November 01st, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Details for read across approach are included into the IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 02

IUPAC Name:

Similar Substance 02

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: approx. 11 weeks.
- Weight at study initiation: males 309 to 322 g and females 202 to 240 g
- Housing: individually housed in polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by Broekman Institute, Someren, The Netherlands).
- Diet: free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmdhle AG, Kaiseraugst, Switzerland).
- Water: free access to tap-water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %:
- Air changes: 15 air changes per hour.
- Photoperiod: lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: one day before exposure an area of approximately 5x7 cm on the back of the animal was clipped. The formulation was applied to an area of approximately 25 cm2 (5x5 cm) for males and 18 cm2 (3.5x5 cm) for females by application on a gauze patch.
- Type of wrap if used: gauze patch was fixed to aluminium foil end flexible bandage, with drops of petrolatum.

REMOVAL OF TEST SUBSTANCE
- Washing: whereafter residual test substance was removed with tissue moistened with tap-water.
- Time after start of exposure: 24 hours.

TEST SUBSTANCE PREPARATION
The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (wlw) was added. Following stirring the test substance preparation formed a solution.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Mortality / Viability: at periodic intervals on the day of dosing (day 1) and twice dai1y thereafter for 14 days.
- Body Weights: days 1 (pre-administration), 8 and 15.
- Symptoms: 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.
- Necropsy of survivors performed: 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.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred during the study period.

Clinical signs:

No clinical signs of ill health or behavioural changes were seen during the study.
No skin irritation was observed on the treated area during the study period. All animals showed blue staining of the treated skin area by the test substance during the study period.

Body weight:

Slight body weight gain was noted among all animals over the first week of observation. All animals showed improved body weight gain over the second week of the study.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (males and females) > 2000 mg/kg bw

Executive summary:

The purpose of the 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 OECO Guideline No. 402, “Acute Dermal Toxicity‘ and EEC Directive 84/449/EEC, Part B.3, "Acute Toxicity ~ Dermal". Test item was administered by dermal application, 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. No clinical signs of ill health or behavioural changes were seen during the observation period. Slight body weight gain was noted over the first week with recovery of body weight gain over the second week of observation.

No signs of skin irritation were observed on the treated area during the study period. All animals showed blue staining of the treated skin by the test substance.

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

Conclusion

LD50 (males and females) > 2000 mg/kg bw