Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate

EC Number:

911-640-3

Molecular formula:

C40H27N7O13S4.4Na

IUPAC Name:

tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate

Details on test material:

SMILE notation for Vapour pressure
O=S(=O)(O[Na])c8cccc1c8cc(cc1S(=O)(=O)O[Na])/N=N/c7ccc(/N=N/c5ccc(/N=N/c2c(O)c3ccc(N)cc3cc2S(=O)(=O)O[Na])c4cc(ccc45)S(=O)(=O)O[Na])c6ccccc67

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

HealthySpregue-Dawley RAI.f. (SPF) (Ra25) derived rats were used. These were bred on the premises. Aged 6-7 weeks, and had an average body weight of 154 g. (male) and 127 g. (female).
Rats were caged singly and kept in a room maintained at a temperature of 21°C. Animals were subjected to 12 hours artificiale light and 12 hours darkness in each 24 hour period. A commercial autoclavable pelleted diet (Labsure CMR Rat and mouse nuts) was fed and lib. Water filtered at 0.45 micron was available at all times.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

A 25% w/v suspension of the compound in a 0.5% aqueous solution of carboxymethyl cellulose was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20ml/kg. (equivalent to 5g/kg of compound)

Doses:

5g/kg

No. of animals per sex per dose:

5 females and 5 males per dose

Control animals:

no

Details on study design:

After administration of the compound, the animals were observed for 14 days. Death and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no death

Clinical signs:

other: no abnormalities

Gross pathology:

dark kidney surfaces in 3/5 male and 4/5 female animals

Other findings:

Black stained urine and faeces were seen from 3 hours up to 6 days post dose. No abnormalities were seen from day 7 until the study terminated on day 14. At terminal autopsy the only abnormalities noted were dark kidney surfaces in 3/5 male and 4/5 female animals.

Applicant's summary and conclusion

Interpretation of results:

other: not classigied under Regulation 1272/2008

Conclusions:

The substance was tested for acute toxicity oral follwoing OECD 420. Under the experimental conditions the substance showed LD50 (LDo= > 5000 mg/kg and did not show any toxicity signs over the 14 days period of observation

Executive summary:

The substance was tested following OECD 420. Ten rats, five males and five females, were kept and fed in the same conditions by a 25% w/v suspension of the compound in a 0.5% aqueous solution of carboxymethyl cellulose. The substance was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20ml/kg. (equivalent to 5mg/kg of compound). After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. No abnormalities were seen from day 7 until the study terminated on day 14. At terminal autopsy the only abnormalities noted were dark kidney surfaces in 3/5 male and 4/5 female animals. The substance can be considered as non toxic at doses ca. 5000 mg(kg bw