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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to recommended guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
4-[[4-( 4-Hyd roxyphenylmethyl)-1-piperidinyl]- 1-oxobuthyl]-a,a-dimethylbenzenacetic acid
IUPAC Name:
4-[[4-( 4-Hyd roxyphenylmethyl)-1-piperidinyl]- 1-oxobuthyl]-a,a-dimethylbenzenacetic acid
Constituent 2
Chemical structure
Reference substance name:
2-(4-{4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid
EC Number:
616-390-6
Cas Number:
76811-98-8
Molecular formula:
C32H37NO4
IUPAC Name:
2-(4-{4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Acclimatization: Minimum of five days before the treatment in the laboratory animal house where the experiment took place.

Housing: Daily observations were performed at the time of delivery of the animals and during the period of acclimatization. Animals were housed in
cages of standard dimensions with sawdust bedding (or equivalent). Cages were cleaned at least once per week. The animals were placed in an
air-conditioned (19-23°C) animal house kept at relative humidity between 45% and 65% in which non-recycled filtered air was changed approximately 10 times per hour. The artificial day/night cycle involved 12 hours light and 12 hours darkness with light on at 7.30 a.m.

Feeding: RM1 (E)-SQC SDS/DIETEX (quality controlled/radiation sterilised) was available ad libitum. The criteria for acceptable levels of contaminants in the feed supply were within the limits of the analytical specifications established by the diet manufacturer.

Drinking water: Drinking water was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is obtained every 6 months and sent to the Laboratoire Départemental d' Analyse du Cher- 216, Rue Louis Mallet- 18014 Bourges Cedex, France, for analysis. The criteria for acceptable levels of contaminants in the water supply were within the limits of the analytical specifications.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
FEX0-080 was applied to the back of the animal on a previously shaved area.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/males/2000 mg/kg
5/females/2000 mg/kg
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 mortality occurred during the study.
Clinical signs:
other: No clinical signs were observed during the course of the study. The results are presented in table 2.3, page 25 and table 2.4, page 26. The application of the test substance did not induce colouring of the application site and did not interfere with the g
Gross pathology:
No organ or tissue gross findings were seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute dermal toxicity.