o-anisidine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 2 FEB 1988 to 16 FEB 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

o-anisidine

EC Number:

201-963-1

EC Name:

o-anisidine

Cas Number:

90-04-0

Molecular formula:

C7H9NO

IUPAC Name:

2-methoxyaniline

Details on test material:

- Name of test material (as cited in study report): o-Anisidin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-breed
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: males mean: 230 g; females mean: 208 g
- Housing: single caged in macrolon cages (type 3) in fully airconditioned rooms
- Diet: rats diet Altromin1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 cm x 8 cm
- Type of wrap if used: aluminium film and additionally elastic patch dressing

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.84 ml/kg bw

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 weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animals died during the 14 days observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - observed clinical signs: ataxia, lacrimation, eyelid constriction, ruffeled fur - day 1 post application: urine was orange - day 2 post application: no more clinical signs observed

Gross pathology:

- no macroscopically visible changes found

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Single dermal application of 2000 mg/kg bw test material o-Anisidin did not cause lethality in male and female Wistar rats thus resulting in a LD 50 > 2000 mg/kg bw. The test results are adequat to fulfil the endpoint requirements.

Executive summary:

Male and female Wistar rats were subjected to test acute dermal toxicity according to a standard acute method (OECD TG 402). The test material o-Anisidin was administered at limit dose 2000 mg/kg bw. Animals showed some clinical signs but no lethality was observed during the 14 days observation period, leading to a LD50 > 2000 mg/kg bw.