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Administrative data

Description of key information

The dermal LD50 is > 2000 mg/kg (male/female rat).
The oral LD50 is > 5000 mg/kg (male/female rat).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A reliable secondary source, summarising terfenadine pharmaco-toxicological properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on 2012; therefore it covers the most updated literature on the substance.
Qualifier:
no guideline available
Principles of method if other than guideline:
The method is not specified
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks:
Terfenadine
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 toxicity
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
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.
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The substance is not considered toxic for oral and dermal acute exposure


Justification for selection of acute toxicity – oral endpoint
The value used is obtained from study on rat

Justification for selection of acute toxicity – dermal endpoint
This value is achieved from a study performed according to recommended guidelines.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for acute oral and dermal toxicity