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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13-13-2001/3-01-2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
other: HanBrl:WIST (SPF)
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Duration of exposure:
24 h
Doses:
The test item 2000 mg/kg dose was diluted in the vehicle at a concentration of 0.5 g/mL and administered at as a volume of 4 mL/kg.
No. of animals per sex per dose:
5 females and 5 males
Control animals:
not required
Details on study design:
- Mortality/ Viability: Daily during acclimatization and twice daily during days 1-15.
- Body weights: On test days 1 (pre-administration), 8 and 15.
- Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
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.
Mortality:
No mortality occurred throughout the study.
Clinical signs:
Red skin and test item residuals were evident in all animals from test day 2 to days 7 or 11. Slight scales on the back were observed in wo males and two females from test day 8 until test day 11.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose of FAT 41034/A after single dermal administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg bw.
Executive summary:

A group of five male and five female HanBrl: WIST rats were treated with FAT 41'034/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered at a volume of 4 mL/kg. The animals were examined for clinical signs four times during test day1 and once daily during the test days 2 -15. Mortality/viability was recorded together with the clinical signs at the same time intervals on the test day1. During the test days 2 -15 it was recorded two times a day. BW were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred throughout the study. Red skin and test item residuals were evident in all animals from test day 2 to days 7 or 11. Slight scales on the back were observed in two males and two feamles from test day 8 until test day 11. The bw of the animals were within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. As a conclusion, the median lethal dose of FAT 41034/A after single dermal administration to rats of both sexes, observed over a period of 14 days was greater than 2000 mg/kg bw.