Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-09-10 to 2007-09-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guidelines for the Testing of Chemicals, No. 402.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987-02-24

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

92/69/EC

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

EC Number:

616-651-4

Cas Number:

787582-75-6

Molecular formula:

C26H2 lF702

Constituent 2

Reference substance name:

APUQU-2-F

IUPAC Name:

APUQU-2-F

Details on test material:

Batch: E06000594
Purity: (GC): 99.9 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rat, Wistar HsdCpb: WU, males (m) and females (f)
Breeder: F. Winkelmann, DE-33178 Borchen
Age: approx. 9 - 10 weeks

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

paraffin oil

Details on dermal exposure:

Backs and abdomens of the rats shaved with electric hair clipper, not later than 1 h before treatment.
Directly before administration test material was moistened with liquid paraffin, spread on the shaven skin, area ca. 6x6 cm, covered with gauze patch, kept in place by self-adhesive fabric. After exposure period of 24 hours gauze and adhesive fabric were removed and any remaining test material wiped off carefully.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Test substance was tested for acute toxicity in 5 male and 5 female rats after dermal administration of 2000 mg/kg body weight. Directly before administration the test material was moistened with liquid paraffin, spread on the shaven skin and covered with a gauze patch, which was kept in place by self-adhesive fabric. After exposure time of 24 hours the gauze and adhesive fabric were removed, wiping off any remaining test material.

Statistics:

Body weight data were recorded with the validated PC-program "AKUDAT", statistical evaluations of body weight development carried out with "TOX 511A".

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths during the course of the study.

Clinical signs:

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg.

Body weight:

The body weight development was inconspicuous. All rats were weighed before treatment and on days 2, 4, 6, 8, 11, 13 and 15 of the experimental part.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Other findings:

None.

Any other information on results incl. tables

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study, so the lethal dose is expected to be > 2000 mg/kg bw. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.

Executive summary:

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study, so the lethal dose is expected to be higher than the limit dose tested. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.