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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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:
- 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
Body weight:
- body weight development was not impaired
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.