2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate

EC Number:

219-949-9

EC Name:

2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate

Cas Number:

2580-78-1

Molecular formula:

C22H18N2O11S3.2Na C22H18N2Na2O11S3

IUPAC Name:

disodium 1-amino-9,10-dioxo-4-[(3-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue 19

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: NA
- Weight at study initiation: 82 - 108 g (mean: 95 g)
- Fasting period before study: 16 hours prior and 2 hours after gavage
- Housing: in groups
- Diet (e.g. ad libitum): ALTROMlN 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: NA (own breeding)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

25 g/mL in deionized water

Doses:

6300, 8000, 10000, 12500 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: frequently on day 1, twice daily thereafter
- Frequency of weighing: weekly
- Necropsy of died animals performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis according to LINDER and WEBER

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

10 135 mg/kg bw

Based on:

test mat.

95% CL:

9 355 - 10 979

Remarks on result:

other: p = 0.05

Mortality:

6300 mg/kg: 0/10
8000 mg/kg: 1/10
10000 mg/kg: 3/10
12500 mg/kg:10/10

Deaths occurred between 30 minutes and 12 hours after gavage

Clinical signs:

other: Died animals showed the following signs prior to death: ataxia, prone position, lateral position Visible skin was bluish discolored in all treated animals After 24 hours: all surviving rats: NAD

Gross pathology:

died animals: bluish discolored inner organs

Other findings:

The dye was excreted via urine and feces.

Any other information on results incl. tables

Dose [mg/kg bw]	Mortality
6300	0/10
8000	1/10
10000	3/10
12500	10/10

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50: 10135 mg/kg bw

Executive summary:

The dye, which is present as a dark blue powder, was administered as an aqueous solution in different doses once by gavage to female SPF Wistar rats of own breeding weighing 82 - 108 g (average weight 95 g). The test was performed in female rats, as sex-related differences could not be determined in preliminary tests. Ten rats were used per dose. The rats were deprived of food 16 hours before application. 2 hours after administration of the dye, the rats were given food again. The observation period after application was 14 days. During this period, in which the animals were weighed weekly, the animals were fed the husbandry diet ALTROMIN 1324 from the company Altrogge in Lage/Lippe and tap water. Feed and water were offered ad libitum. The animals were kept in plastic cages on wood shavings. Lethally poisoned animals were dissected and macroscopically assessed.

The LD50 was determined by means of a probit analysis (method according to LINDER and WEBER); the confidence limits were calculated according to  CAVALLI-SFORZA (Dept. of Practical Mathematics of Hoechst Aktiengesellschaft).

Fatally poisoned animals died, after showing ataxia, in prone or lateral position. The hairless parts of the body were coloured blue. The dye was excreted with the faeces and urine. The body weight development of individual animals in the 10000 mg/kg bw group was delayed. The necropsy of the dead animals showed macroscopically a blue colouration of the internal organs.

Acute oral toxicity testing revealed an LD50 of 10135 mg/kg body weight. According to the usual classification based on acute toxicity (W.S. SPECTOR in the "Handbook of Toxicology"), the present dye would be considered practically non-toxic after a single oral administration.