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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF guidance (2000), including the most recent 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:

other: Wistar strain Crl:WI (Han)

Sex:

male/female

Administration / exposure

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x7 cm on the back of the animal was clipped.
- % coverage: approx. 10% of the total body surface, i.e. approx. 25cm2 for males and 18 cm2 for females

Duration of exposure:

Single dosage, on Day 1.

Doses:

2000 mg/kg (10 mL/kg) body weight.

No. of animals per sex per dose:

No.1 of animals is male
No.2 of animals is male
No.3 of animals is male
No.4 of animals is male
No.5 of animals is male
No.6 of animals is female
No.7 of animals is female
No.8 of animals is female
No.9 of animals is female
No.10 of animals is female

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: Lethargy, hunched posture, uncoordinated movements, quick breathing labored respiration, piloerection chromodacryorrhoea, ptosis and/or hypothermia were shown by all animals between Days 1 and 3, and for one male hunched posture was also noted on Day 11.

Other findings:

No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

TABLE 1 MORTALITY DATA

TEST DATE

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

HOURS AFTER TREATMENT

0

2

4

MALES 2000 MG/KG

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

FEMALES 2000 MG/KG

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

­

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

Everzol Orange ED-G Crude was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred.

Lethargy, hunched posture, uncoordinated movements, quick breathing, labored respiration, piloerection, chromodacryorrhoea, ptosis and/or hypothermia were shown by all animals between Days 1 and 3, and for one male hunched posture was also noted on Day 11.

The treated skin area of all animals showed scales and/or scabs between Days 4 and 15, and showed brown staining between Days 2 and 15. The treated skin area of all animals showed scales and/or scabs between Days 4 and 15, and showed brown staining between Days 2 and 15. Due to brown-red discolouration of the treated skin on Day 2, no scoring of the treated skin area was possible on that observation day.

The body weight gain during the observation period was within the range expected for rats used in this type of study.
No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD5O value of Everzol Orange ED-G Crude in Wistar rats was established to exceed 2000 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 acute dermal toxicity according to the: - Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), - Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.