Glycine, N-[5-(acetylamino)-4-[2-(2-bromo-4,6-dinitrophenyl)diazenyl]-2-methoxyphenyl]-N-(2-methoxy-2-oxoethyl)-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 02 December 2014 to 02 January 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline, coherence between data, results and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Blue ANT

IUPAC Name:

Disperse Blue ANT

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Disperse Blue ANT

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: approximately 9 - 10 weeks
- Weight at study initiation: 162-170 grams
- Fasting period before study: approximately 16 hours prior to dosing
- Housing: 3 animals/cage
- Diet (e.g. ad libitum): ad libitum, except for the fasting period prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C+/-2 °C
- Humidity (%): 55%+/-15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: To: From: 09 December 2014 (Allocation of the animals to the first group) To: 02 January 2015 (Last necropsy procedure)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

: water 1:1

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: solubility of the test item


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for clinical signs on dosing, approximately 0.5,
2, 4 hours after dosing on the day of treatment and daily thereafter. All animals were weighed at allocation to the
study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
- Necropsy of survivors performed: yes, gross necropsy examination for both external and internal abnormalities,
with particular attention to the gastro-intestinal tract.

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: In the first group of animals, blue staining on the dorsal region and perianal region was individually observed from Day 2 up to Day 8. In the second group of 3 female animals, generalised blue staining (i.e. on the dorsum/dorsal region, hindlimb/forelim

Gross pathology:

No abnormalities were observed at necropsy examination.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

These results indicate that the test item, Disperse Blue ANT, did not induce toxic effects in the rat following oral administration of a single dose
at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.

Executive summary:

The acute toxicity of Disperse Blue ANT was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg body weight (Step 1). No mortality occurred and no signs of toxicity were noted. The only finding observed was blue staining on perianal and/or sacral dorsal region in all animals from Day 2 up to Day 8. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no signs of toxicity were seen. Generalised blue staining was individually observed starting from the day of dosing up to Day 7. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item, Disperse Blue ANT, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg body weight.