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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 14 April 2015 To
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Acid Red EAY 9656

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at arrival: approximately 6 - 7 weeks
- Weight at arrival: 170-183 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: 15 April 2015 To: 07 May 2015

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: PEG 400 - water 1:1 v/v
Details on oral exposure:
VEHICLE
PEG 400 - water 1:1 v/v
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Solubility of the test item. A solubility test was initially carried out in 0.5% CMC. The suspension obtained was not suitable for dosing and PEG 400 - water 1:1 v/v was found to give a good suspension.


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:
2000 mg/kg
No. of animals per sex per dose:
6 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 dosing.

treatment and daily thereafter. All animals were weighted at allocation to the study (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:
In first group of animals, clinical signs were limited to red staining of the tail in all animals from Day 2 up to Day 15. In the further group of 3 females,
all animals showed red staining on the tail from Day 2 up to Day 15.
Red staining and/or red faeces were seen in the sawdust from Day 2 up to Day 4.
Body weight:
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
Gross pathology:
Red staining on the tail was observed in all animals at necropsy examination performed at the end of the observation period.
No other findings were observed.

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 Acid Red EAY 9656 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 Acid Red EAY 9656 was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. Two groups (Groups 2 and 3), each of 3 female animals were subsequently dosed at 2000 mg/kg body weight (Steps 1 and 2). No mortality occurred and no significant clinical signs were observed. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No significant findings were observed at necropsy examination performed at the end of the observation period. These results indicate that the test item Acid Red EAY 9656 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.

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