2,6-difluorobenzamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Non-GLP, near guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-difluorobenzamide

EC Number:

241-972-8

EC Name:

2,6-difluorobenzamide

Cas Number:

18063-03-1

Molecular formula:

C7H5F2NO

IUPAC Name:

2,6-difluorobenzamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Batch number: 722.35
ST number: ST86/206
Characterisation: no purity data available- commercial sample
Appearance: white powder

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 220 g (males) and 151 g (females)
- Housing: single sex groups of 2-3 in cages with stainless-steel wire-mesh floors and tops; each cage measured 38 x 25 x 18 cm
- Diet: PRD (Labsure animal Foods, Dorset, UK), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened powder

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal site
- % coverage: 60% of dorsal site
- Type of wrap if used: aluminium foil lined with gauze , fixed by a double overwrap of waterproof adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with warm dilute detergent solution and then dried
- Time after start of exposure: 24 h

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: Observations were recorded three times a day for the first three days and daily thereafter. The initial (i.e. day 1), day 7 and day 14 body weights were recorded;
- Necropsy of survivors performed: no;
- Other examinations performed: clinical signs and body weight.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: no effects

Gross pathology:

not investigated

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose of the test item after dermal application was found to be greater than 2000 mg/ka bw.

Executive summary:

The acute dermal toxicity of the test item was evaluated on the basis of a study similar to the OECD guideline 402.

There were no clinical signs and all rats had gained weight relative to their day 1 bodyweights ba the end of the 14 day observation perios. None of the rats died from which it was concluded that the acute dermal median lethal dose (LD50) of the test item, applied as a moistened powder, in rats was greater than 2000 mg/kg bw.