GOLDEN YELLOW SCJ 1006

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECG guideline study under GLP without deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

92/69/EEC, B1

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 40543/A
Description: Red powder
Batch: TV RN 196-200
Purity: 90%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: November 01, 2000
Stability in vehicle: 1% Aq. carboxymethyl cellulose: not indicated

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species: Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EEC).
Source: Charles River, Germany
Age at Start of Treatment: Approx. 7 weeks
Body weight at start of treatment: Within ± 20% of the sex mean
Number of animals: 5 males and 5 females
Identification: Earmark
ANIMAL HUSBANDRY
Conditions : Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21 °C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation: Group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands). Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium). Certificates of analysis are examined and then retained in the NOTOX archives.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1 % aqueous carboxymethyl cellulose

Details on oral exposure:

Method: Oral gavage
Fasting: Food was withheld overnight prior to dosing until approximately 3 - 4 hours after administration of the test substance.
Frequency: Once, on day 1.
Dose level (volume): 2000 mg/kg (10 ml/kg) body weight.

Doses:

2000 mg/kg bw (single dose)

No. of animals per sex per dose:

males and 5 females

Control animals:

no

Details on study design:

OBSERVATIONS
Mortality/Viability: Twice daily.
Body weight recordings: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded.
Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide asphyxiation and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No deaths occurred and no signs of toxicity were observed. Generalised red colouration of the skin days 3 to 6, skin on the backs of males (5) and females (1) days 2 to 7, and tail on day 2 (males). Red colourat

Gross pathology:

Effects on organs:
No treatment-related macroscopic findings were observed.

Other findings:

Pelvic dilation of the kidney, found in one male, is commonly noted among rats of this age and strain and was therefore considered not toxicologically significant. No further abnormalities were found at macroscopic post mortem examination of the animals at termination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral (gavage) LD50 of FAT40543/A is >2000 mg/kg bw; no mortality was observed at the dose of 2000 mg/kg bw.

Executive summary:

The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 92/69/EEC, Part B.l, "Acute Toxicity-Oral".

FAT40543/A was administered by oral gavage to five rats of each sex 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. Clinical signs, including red skin and red faeces, were observed in all animals. These symptoms had completely disappeared by day 8. Body weight gain shown by the animals over the study period was considered to be normal. No treatment related abnormalities were found in the animals at macroscopic post mortem examination. The oral LD50 value of FAT 40543/A in rats was established as exceeding 2000 mg/kg body weight.