3-amino-4-methoxybenzanilide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EEC

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-4-methoxybenzanilide

EC Number:

204-388-4

EC Name:

3-amino-4-methoxybenzanilide

Cas Number:

120-35-4

Molecular formula:

C14H14N2O2

IUPAC Name:

3-amino-4-methoxy-N-phenylbenzamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, Kastengrund, SPF-breed
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male 197 g - 213 g, female 194 g - 206 g on day 1 (treatment)
- Fasting period before study: approximately 16 hours before treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Albtromin 1324)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: none, because bread under identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.5 g test substance + 0.5 ml physiolog. saline
- For solids, paste formed: yes
- prepared paste was arranged on 6 cm x 8 cm aluminium foil

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

TEST SITE
- approximately 30 cm2 of the back were shaved; prepared test substance paste on aluminium foil was placed on the dorsal skin and fixed
- Area of exposure: approximately 6 cm x 8 cm;
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 24 hours

- Duration of observation period following administration: 14 days starting with treatment day 0
- Frequency of observations and weighing:
mortality/viability: during the first 30 minutes and approximately 1, 2, 4 and 6 h after administration on day 0 and twice daily on days 1-14
clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 6 h after administration on day 0 and twice daily on days 1-14
body weights: on days 0 (prior to administration), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: none

Gross pathology:

No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

67/548/EEC: Acute dermal toxicity: no classification warranted
1272/2008/EC: Acute dermal toxicity: no classification warranted

Executive summary:

One group of five male HoeWISK (SPF71) rats and one group of five female HoeWISK (SPF71) rats were treated with the test item by dermal route administration at a dosage of 2000 mg/kg body weight. 0.5 g the test item was pasted in 0.5 ml vehicle (pyhsiolog. saline) .

The animals were examined twice daily during and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 4 and 6 hours after treatment on day 0 and once daily during test days 1 -14. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 4 and 6 hours after administration on test day 0 (with the clinical signs) and daily during days 1 -14. Body weights were recorded on day 0 (prior to administration) and on days 7 and 14. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period.

No macroscopic findings were recorded for the animals at scheduled necropsy.

The median lethal dose of the test item after single dermal administration to male and female rats, observed over a period of 14 days is:

LD50 (rat): greater than 2000mg/kg body weight