1,7-Naphthalenedisulfonic acid, 4-amino-3-[(1E)-2-(2,4-disulfophenyl)diazenyl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfophenyl)diazenyl]-, sodium salt (1:5)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 April 2015 - 29 September 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed at a GLP laboratory in accordance with OECD, EU and US testing guidelines for the assessment of Acute Oral Toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

A deviation in the daily mean humidity was observed during the study, however this deviation did not affect the validity of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

A deviation in the daily mean humidity was observed during the study, however this deviation did not affect the validity of the study.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

A deviation in the daily mean humidity was observed during the study, however this deviation did not affect the validity of the study.

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000), including the most recent revisions.

Deviations:

yes

Remarks:

A deviation in the daily mean humidity was observed during the study, however this deviation did not affect the validity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

EC Number:

811-858-8

Cas Number:

2149571-68-4

Molecular formula:

C22 H11 N6 O18 S5 .5Na

IUPAC Name:

pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Constituent 2

Reference substance name:

pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate

IUPAC Name:

pentasodium 4-amino-3-[(2,4- disulfonatophenyl)diazenyl]-5-hydroxy-6-[(4-nitro-2- sulfonatophenyl)diazenyl]naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): 206474/A
- Physical state: Powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx. 9-10 weeks old
- Weight at study initiation: Weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: 3 animals per cage in labeled Makrolon cages containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): 10
- Photoperiod: 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20-23%
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was selected based on trial preparations and on test substance data supplied by the Sponsor.

MAXIMUM DOSE VOLUME APPLIED: 2000 MG/KG

Doses:

2000 mg/KG

No. of animals per sex per dose:

Each dose group consisted of 3 animals (female).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were subjected to daily observations and weekly determination of body weight.
- Necropsy of survivors performed: yes, Macroscopic examination was performed after terminal sacrifice (Day 15).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and/or piloerection were noted animals on Day 1. Blue discolouration of the skin/fur, faeces and urine were noted for all animals on Day 1 and/or 2. This was considered to be due to the test substance.

Gross pathology:

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

Other findings:

.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).

Executive summary:

The test substance 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 animals on Day 1.

Blue discolouration of the skin/fur, faeces and urine were noted for all animals on Day 1 and/or 2. This was considered to be due to the test substance.

The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of K1600 black dye in Wistar rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, K1600 black dye does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).