Disodium 3,3'-[[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(3-methoxy-4,1-phenylene)azo]]bis[benzenesulphonate]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Remarks:

source study on the analogous substance

Adequacy of study:

key study

Study period:

From November 18 to December 07, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

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 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany.
- Age at study initiation: 9 weeks.
- Weight at study initiation: 308 - 377 g males; 229 - 234 g females.
- Housing: individually housed in polycarbonate cages containing purified sawdust as bedding material (Woody Clean supplied by Broekman Institute, Someren, The Netherlands).
- Diet: standard pelleted laboratory animal diet (RMH-B from Hope Farms, Woerden, The Netherlands), ad libitum.
- Water: tap-water, diluted with decalcified water, ad libitum.
- Acclimation period: 5 days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Relative dumidity: 30 - 70 %
- Air changes: 7.5-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark per day.

Administration / exposure

Vehicle:

water

Remarks:

prepared by reverse osmosis

Details on dermal exposure:

FORMULATION
The formulations were prepared immediately prior to dosing. The test article was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added.
Homogeneity of the test article in vehicle was obtained by a homogeniser.

TREATMENT
- Shaving: one day before treatment (day -1) an area of approximately 5 x 7 cm on the back of the animal was clipped.
- Application: approximately 25 cm^2 (5 x 5 cm) for males and 18 cm2 (3.5 x 5 cm) for females was applied using a gauze patch fixed, successively, to aluminium foil and flexible bandage (Cohan, 3M, St. Paul, U.S.A.), with drops of vaseline.
- Dose volume: 10 ml/kg bw

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.
- Frequency of observations: at periodic intervals on the day dosing (day 1) and twice daily thereafter for at least 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convuision, salivations, diarrhoea, lethargy, sleep and coma. Changes of the treated skin were described immediately after bandage removal (day 2), on day 5, 8 and 15.
- Frequency of weighing: test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: all animals were necropsied and descriptions of all macroscopic abnormalities were recorded. All animals surviving to the end of the observation period were sacrified by carbon dioxide asphyxiation and subjected to necropsy.

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:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred during the study period.

Clinical signs:

There were no treatment related signs of toxicity over the 15 day observation period.
The treated skin surface of animals showed no irritation. During the study period all animals showed orange discolouration of the treated skin, due to staining by the test substance.

Body weight:

With the exception of animal 9, all animals showed body weight gain during the study period.

Gross pathology:

Macroscopic examination of all animals at the end of the study showed in one female red discolouration and thickened wall of the forestomach accompanied by blister-like areas.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

The substance was administered to rats of both sexes by dermal application at 2000 mg/kg body weight for 24 hours. No mortality occurred during the study period.

There were no treatment related signs of toxicity over the 15 day observation period. With the exception of animal 9, all animals showed body weight gain during the study period. The treated skin surface of animals showed no irritation. During the study period all animals showed orange discolouration of the treated skin, due to staining by the test substance. Macroscopic examination of all animals at the end of the study showed in one female red discolouration and thickened wall of the forestomach accompanied by blister-like areas.

The dermal LD50 value in rats of both sexes was estimated to exceed 2000 mg/kg body weight.

Conclusion

LD50 (male and female) > 2000 mg/kg bw