Registration Dossier
Registration Dossier
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EC number: 228-782-0 | CAS number: 6358-64-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-02-02 to 1988-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP study following previous OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP compliance statement attache to full study report.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-chloro-2,5-dimethoxyaniline
- EC Number:
- 228-782-0
- EC Name:
- 4-chloro-2,5-dimethoxyaniline
- Cas Number:
- 6358-64-1
- Molecular formula:
- C8H10ClNO2
- IUPAC Name:
- 4-chloro-2,5-dimethoxyaniline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, Kastengrund, SPF breed
- Weight at start of study:
male animals: mean = 203 +/- 5 g (min: 196 g, max: 208 g)
female animals: mean = 194 +/- 6 g (min: 188 g, max: 201 g)
- Age at start of study:
male: approx. 7 weeks
female: approx. 9 weeks
- Randomization: according to protocol No 1406/87 and 60/88
- Housing: in air conditioned rooms, single cages
- Room temperature: 22 +/-3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Acclimatisation: min 5 days
- Diet: rat diet Altromin 1324, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Identification: Numbering of cages
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1g of the test item was moistened with 0.8mL of 0.9% NaCl
- Details on dermal exposure:
- - Area of coverage: 6x8 cm
- Washing: after 24 hrs of exposure with luke warm water - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Observation time after treatment: 14 days
- Weekly weighing of animals
- After observation time, sacrifice of animals, necropsy and gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None.
- Clinical signs:
- other: None.
- Gross pathology:
- No findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the present study 4-chloro-2,5-dimethoxyaniline is not classified as hazardous according to 83/467/EEC.
- Executive summary:
In the present study the acute dermal toxicity of 4 -chloro-2,5 -dimethoxyaniline was determined in a limit test with a concentration of 2000mg/kg bw using 5 male and 5 female Wistar rats. Neither mortality nor other adverse effects were observed following an exposure of 24hrs. Based on these findings 4 -chloro-2,5 -dimethoxyaniline is not classified as hazardous according to 83/467/EEC.
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