Golden Yellow Continuous

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 May 2009 to 03 June 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 423 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name: Golden Yellow Continuous

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd., 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 206 g to 231 g
- Fasting period before study: over night until 3 hours post treatment
- Housing: Group caging (3 animals/cage)
- Diet: ssniff® SM R/M-Z+H ad libitum
- Water: tap water ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 19 May 2009 To: 02 June 2009

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubiltity in vehicle
- Lot/batch no. (if required): 1421464



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: test item was considered to have low toxicity based on experience with similar compounds

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: 30 minutes, 1, 2, 3, 4 and 6 hours after dosing on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths occurred

Clinical signs:

other: no adverse effects

Gross pathology:

no findings

Other findings:

Day 1: red staining (test item) of feces in Group 2

Any other information on results incl. tables

Mortality:

Treatment group:	1	2
Dose (mg/kg bw):	2000	2000
Number of animals treated:	3	3
Mortality:	0/3	0/3

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item GOLDEN YELLOW CONTINUOUS was above 2000 mg/kg bw in female CRL:(WI) BR rats.
GOLDEN YELLOW CONTINUOUS was ranked into Category 5 of the Globally Harmonized Classification System.

Executive summary:

The single-dose oral toxicity of GOLDEN YELLOW CONTINUOUS was performed according to the acute toxic class method (OECD 423, OPPTS 870.1100 and Commission Regulation (EC) No 440/2008, B.1 tris (L 142, 30 May 2008)) in CRL: (WI) BR rats. The study was performed at a dose level of 2000 mg/kg body weight (bw). Two groups of three female CRL: (WI) BR Wistar rats (about 8 weeks of age) were treated with a solution of GOLDEN YELLOW CONTINUOUS in Polyethylene-glycol (PEG) 400 at 2000 mg/kg bw by oral gavage (Groups 1 and 2). Initially, three females (Group 1) were treated at 2000 mg/kg bw. As no mortality occurred in this dose group within 24 hours after dosing, a confirmatory treatment according to OECD 423 was performed on 3 further females at the same dose level (2000 mg/kg bw). Rats were maintained without compound administration for a 2-week observation period after the day of dosing. As no mortality was observed in the second dose group, no further treatment was needed. A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. GOLDEN YELLOW CONTINUOUS was administered at a concentration of 200 mg/mL (Groups 1 and 2) prepared in PEG400 with a treatment volume of 10 mL/kg bw. Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Bodyweight was measured on Days -1, 0 and 7 and before necropsy. Gross necropsy was performed on all animals (Day 14).

Mortality

GOLDEN YELLOW CONTINUOUS did not cause mortality at 2000 mg/kg bw.

Clinical observations

No adverse clinical signs were observed after the treatment with the test item or during the 14 day observation period.

Bodyweight and Bodyweight gain

Bodyweight gains of GOLDEN YELLOW CONTINUOUS treated animals during the study showed no indication of a test item-related effect.

Macroscopic Findings

A single oral gavage of Golden Yellow Continuous to the CRL: (WI) BR rat at a dose level of 2000 mg/kg bw, followed by a 14 day observation period, was not associated with any test item-related macroscopic findings.

Conclusion: Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item GOLDEN YELLOW CONTINUOUS was greater than 2000 mg/kg bw in female CRL:(WI) BR rats.