Benzoic acid, 3,5-diamino-4-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-2-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:?)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: - Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-890-9

EC Name:

-

Cas Number:

906532-68-1

Molecular formula:

C23H24N6O17S5 · xNa

IUPAC Name:

sodium 3,5-diamino-2-[(E)-2-{2-sulfo-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-4-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzoate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han)

Administration / exposure

Vehicle:

water

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No mortality occurred. Hunched posture and/or piloerection were noted in all animals on Day 1 and red faeces were noted in all animals on Day 2.

Gross pathology:

Effects on organs:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Everzol Orange ED-G Crude in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

Everzol Orange ED-G Crude was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.

Hunched posture and/or piloerection were noted in all animals on Day 1 and red faeces were noted in all animals on Day 2.
The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of Everzol Orange ED-G Crude in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline the LD5O cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results Everzol Orange ED-G Crude does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).