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acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experiment start date - 20 May 1999; Experiment end date - 10 June 1999; Study completion date - 22 June 1999.
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na
trisodium 3-amino-4-[2-(4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40574/B
- Physical state: solid
- Analytical purity: Approx 75%
- Lot/batch No.: WP 23/99
Specific details on test material used for the study:
Identity: FAT 40574/B
Batch: WP 23/99
Purity: Approx. 75 %
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006

Test animals

Details on test animals or test system and environmental conditions:
Age when treated: Females: 11 weeks; Males: 9 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, with target ranges for room temperature 22 ± 3 °C and relative humidity 40-70 % (values above 70% during cleaning process possible). Room environment was monitored continuously with hourly recordings. The room was illuminated by fluorescent light on a 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period.
Accommodation: Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
Diet: Pelleted standard Kliba 3433, batch no. 35/98, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation).
Water: Community tap water from Itingen, available ad libitum.

Administration / exposure

Type of coverage:
other: Bidistilled water
Details on dermal exposure:
Approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test article was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Application volume/kg body weight: 6.0 ml
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
Duration of exposure:
24 h
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
Mortality / Viability: Four times during test day 1 and once daily during days 2-15.
Body weights: On test day 1 (pre-administration), 8 and 15.
Clinical signs: Each animal was examined for changes in appearance and behavior four times during day 1, and once daily during days 2-15. A description of all abnormalities was recorded.
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhône Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg
sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities recorded. Thereafter, they were discarded.
No statistical analysis was used as no deaths occurred.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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: CLINICAL SIGNS: No clinical signs of toxicity were observed. BODY WEIGHTS: No changes on body weights noted.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
Signs of toxicity (local):
Test article remnants were observed in one animal between day 2 and day 13 and in two animals between day 2 until the end of the observation period. Slight scaling was noted until day 6 (two animals) and 7 (one animal).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
LD50 of FAT 40574/B was found to be greater than 2000 mg/kg body weight
Executive summary:

The purpose of this study was to assess the acute dermal toxicity of FAT 40574/B when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days. This study was conducted according to OECD test guideline 402 in a GLP-certified laboratory. A group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 40574/B at 2000 mg/kg by dermal application. The test article was suspended in vehicle (bidistilled water) at a concentration of 0.33 g/ml and administered at a volume of 6 ml/kg. The animals were examined for clinical signs four times during day 1 and once daily during days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. In all animals, test article remnants were observed on test day 2 and persisted in two animals until test day 13 and in the other animals until the end of the observation period. In three males, slight to moderate scaling was noted until test day 6 (two animals) and 7 (one animal). The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of FAT 40'574/B after single dermal administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred. LD50: greater than 2000 mg/kg body weight.

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