Registration Dossier
Registration Dossier
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EC number: 202-448-4 | CAS number: 95-76-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- ; limit 1000 not 2000 mg/kg bw , no females tested, reporting deficiencies
- GLP compliance:
- no
- Test type:
- other: limit test
- Limit test:
- yes
Test material
- Reference substance name:
- 3,4-dichloroaniline
- EC Number:
- 202-448-4
- EC Name:
- 3,4-dichloroaniline
- Cas Number:
- 95-76-1
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 3,4-dichloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 3,4-Dichloroanilin rein
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar TNO W 74
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 14 weeks
- Weight at study initiation: 197 g
- Fasting period before study: no
- Housing: 5 animals per Macrolon type III cage
- Diet: ad libitum, Altromin 1324
- Water: ad libitum, tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/ 12
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: liquid not specified
- Details on dermal exposure:
- according to Noakes and Sanderson, 1969, Brit. J. Industr. Med. 26: 59-63
- Duration of exposure:
- 4 or 24 h not specified
- Doses:
- 1000 mg/kg bw
- No. of animals per sex per dose:
- 10 male
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: repeated observation on day of application, twice a day thereafter
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- no data
Results and discussion
Effect levels
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Mortality:
- no mortality observed
- Clinical signs:
- other: no signs of toxicity
- Gross pathology:
- not applicable
Applicant's summary and conclusion
- Executive summary:
Löser, E., 1981
After acute dermal exposure of male Wistar rats to 1000 mg 3,4-dichloroaniline /kg bw no signs of toxicity were evident and no mortality was observed.
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