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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
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)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
EC Number:
926-072-1
Cas Number:
198479-63-9
Molecular formula:
C29H25NO2
IUPAC Name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Description: solid
Batch Number: 0010111968
Purity: 100%
stability of test item: Stable under storage conditions
Stability of test item in vehicle: Unknown, exluded from the statement of compliance
Expiry date: 18-oct-2002
Storage conditions: at room temperature (range of 20±3°C), away from direct sunlight
Safety precautions: Routine hygienic procedures (gloves, goggles, face mask), irritating to eyes, skin and respiratory system.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Duration of exposure:
14 days
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study.
Clinical signs:
Light scales on the back were observed in a male N. 1 on test days two and three and female N.7 on test day ten. Slight erythema maculate was evident in 3 males on test day 2 and in female N.7 on tets day 2 until test day 5. All other animals were without clinical signs.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of TSE 2 after single oral admini stration to rats of both sexes, observed over a period of 14 days is: LD50(rat): greater than 2000 mg/kg bw.

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