GOLDEN YELLOW SCJ 1006

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study performed 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.3 (Acute Toxicity (Dermal))

Version / remarks:

92/69/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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. 8 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: Individually housed 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 were examined and then retained in the NOTOX archives.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 1% aqueous carboxymethyl cellulose.

Details on dermal exposure:

TREATMENT
Method: Dermal application.
Shaving: One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
Application: The test substance formulation was applied to an area of approximately 25 cm² (5x5 cm) for males and 18 cm² (3.5x5 cm) for females by application on a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul, U.S.A.), with drops of petrolatum.
Frequency: Once, on day 1.
Dose level: (volume) 2000 mg/kg (10 ml/kg) body weight.
Application period: 24 hours, thereafter dressings were removed and residual test substance removed using a tissue moistened with tap water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (single application)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

OBSERVATIONS
Mortality/Viability checks: Twice daily.
Body weight recordings: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of treatment (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 occured

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. Lethargy in all animals on day 1 was resolved by day 2.

Gross pathology:

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

Other findings:

Signs of toxicity (local):
Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal 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. 402, "Acute Dermal Toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal".

FAT40543/A was administered to five rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Lethargy was observed in all animals at 4 hours after treatment and had resolved by day 2. Red staining of the skin, the treated area in particular, was observed in all animals and persisted in several animals throughout the observation period. Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination. The dermal LD50 value of FAT40543/A in rats was established as exceeding 2000 mg/kg body weight.