2H-Pyran, 2-[4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-3',5'-difluoro[1,1'-biphenyl]-4-yl]-5-ethyltetrahydro-

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:

guideline 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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-{4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-3',5'-difluoro-[1,1'-biphenyl]-4-yl}-5-ethyloxane

EC Number:

616-651-4

Cas Number:

787582-75-6

Molecular formula:

C26H21F7O2

IUPAC Name:

2-{4'-[difluoro(3,4,5-trifluorophenoxy)methyl]-3',5'-difluoro-[1,1'-biphenyl]-4-yl}-5-ethyloxane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, DE-33178 Borchen
- Age at study initiation: approx. 9 - 10 weeks
- Weight at study initiation: 201 - 255 g
- Housing: separately
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 44 to 70 (The humidity was transiently outside the target range of 45 to 75%. This minor and short deviation did not influence the integrity or the outcome of the study)
- Photoperiod (hrs dark / hrs light): 12/12

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

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: at least 6 hours after administration and then checked daily; body weight: on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the course of the study.

Clinical signs:

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

Gross pathology:

The gross pathological examination revealed no organ alterations.

Other findings:

None.

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 dermal 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 according to OECD Guideline 402 under GLP conditions. 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.