Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
Cas Number:
198480-21-6
Molecular formula:
C44 H46 N2 O3
IUPAC Name:
1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
The test item was diluted in PEG 300 at a concentration of 0.33 g/ml and administered at a volume of 6 ml/kg.
Doses:
2000 mg/kg
No. of animals per sex per dose:
A group of 5 male and 5 female
Details on study design:
The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded togheter with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day.
Body weight were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
Slight erythema and scales on the back were evident in two females and two males between test day two and twelve. All other animals were without clinical signs.
Body weight:
The body weight 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:
other: Not classified based on CLP criteria
Conclusions:
The median lethal dose of TSE8 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg b.w.