1-ethoxy-2,3-difluorobenzene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-01-25 to 2000-02-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

29 Decembre 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-ethoxy-2,3-difluorobenzene

EC Number:

441-000-4

EC Name:

1-ethoxy-2,3-difluorobenzene

Cas Number:

121219-07-6

Molecular formula:

Hill formula: C8H8F2O

IUPAC Name:

1-ethoxy-2,3-difluorobenzene

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdCpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 217 g (range from 202 to 240 g)
- Housing: separately in Makrolon cages type III
- Diet: ad libitum, diet (Altromin Standard Diät TPF®N 1324)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 38 - 66
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs and abdomens, area of 6 x 6 cm
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 1.7 mL/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg

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: daily, weighing was performed on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The body weight data were recorded with the PC-program „AKUDAT". The statistical evaluations of the body weight were carried out with the PC-program „TOX 511 A", developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

All the rats survived the observation period.

Clinical signs:

other: No signs of intoxication and no signs of local irritation occurred after treatment.

Gross pathology:

All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, the test item has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single dermal administration to male and female rats.

Executive summary:

The test substance was tested for acute toxicity in rats after dermal administration of 2000 mg/kg body weight in accordance with OECD guideline 402. Groups of Wistar rats (5/sex) were dermally exposed to the test substance for 24 hours. The test material was a liquid and was spread on the shaven skin in an area of 6 x 6 cm covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). The gauze and adhesive fabric were removed after exposure time and any remaining test material was wiped off carefully. Animals were then observed for 14 days.

No signs of toxicity were detected in the rats after treatment with 2000 mg/kg. Weight development was not affected by the treatment. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Based on the result of this study, the test substance can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.