Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 21, 2001 to January 21, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed according to test guideline in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, this study is used for read-across thus avoiding duplicate tests.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
FAT 41'030/A

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
5.1 TEST SYSTEM
Test system Rat, HanBrl: WIST (SPF)
Rationale Recognized by the international guidelines as a recommended test system.
Source RCC Ud Biotechnology & Animal Breeding Division
Number of animals per group CH-4414 Füllinsdorf
Total number of animals 5 males or 5 females 5 males and 5 females
Age when treated Males: 9 weeks; Females: 11 weeks
Identification By unique cage card and corresponding color-coded spots on the tai!.
Acclimatization Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
5.2 HUSBANDRY
Room no. E 16; E23 from the 28.11-2001 to the end of the study
Conditions Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 ± 3°C and for relative humidity between 30-70%. 12 hours fluorescent light/12 hours dark, music du ring the light period.
Accommodation During acclimatization in groups of five per sex in Makroion type-4 cages with standard softwood bedding. Individually in Makroion type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
Diet: Pelleted standard Provimi Kliba 3433, batch no. 76/01 rat/mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC Ud, Itingen.
Water Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ud, Itingen.




Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: PEG 300
Details on dermal exposure:
Rationale Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weightvolume). The mixture was prepared using a glass stick.
The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
Identity PEG 300
Supplier Fluka Chemie AG, CH-9471
Batch number 424718/1 42701
Expiry date 10-AUG-2002
Storage conditions At room temperature (17-23 °C) in the original container away from direct sunlight
Safety precautions Routine hygienic procedures (gloves, goggles, face mask)
Duration of exposure:
24h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
other: contralateral skin
Details on study design:
On test day 1 , the test item 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.
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.
Statistics:
No statistical analysis was used.

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 deaths occurred during the study. No macroscopic findings were observed at necropsy. Skin colouration was observed until test day 14 or 15 in all animals. The body weight of the animals was within the range commonly recorded.
Mortality:
No deaths occurred during the study.
Clinical signs:
Test item residuals and red skin were observed in all females and two males on test day two until test day 15. In three males the clinical signs above were observed until test day 14.
Body weight:
The body weight of the animals was within the range commonly recorded.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 of the substance after single application is determined to be greater than 2000 mg/kg body weight under the available conditions.
Executive summary:

The study was conducted to determin the acute dermal toxicity of FAT 41030/A according to OECD guideline 402. A group of five male and five female HanBrl: WIST (SPF) rats was treated with FAT 41030/ A at 2000 mg/kg by dermal application. No deaths occurred during the study. Test item residuals and red skin were observed in all females and two males on test day two until test day 15. In three males the clinical signs above were observed until test day 14. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Based on the available results, median lethal dose of FAT 41030/A after single dermal administration to rats of both sexes, observed over aperiod of 14 days is greater than 2000 mg/kg body weight.