Registration Dossier
Registration Dossier
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EC number: 202-448-4 | CAS number: 95-76-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- ; no females tested
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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:
- IUCLID4 Test substance: no data
- Name of test material (as cited in study report): 3,4-Dichloroanilin rein
- Physical state: solid
- Analytical purity: 100 %
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: 9 weeks
- Weight at study initiation: approx. 176 g
- Housing: 5 per Macrolon cage type III
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.3 to 0.8 g/ 20 mL
- Amount of vehicle (if gavage): 2 mL/ 100 g
- Justification for choice of vehicle: non-toxic, good resorption - Doses:
- 0.3, 0.5, 0.6, 0.7 and 0.8 g/kg bw
- No. of animals per sex per dose:
- 10
- 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, all the other days twice a day
- Necropsy of survivors performed: yes some
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- Probit analysis according to Fink and Hund
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 570 mg/kg bw
- Mortality:
- dose 0.3 g/kg bw = 0/10
dose 0.5 g/kg bw = 2/10
dose 0.6 g/kg bw = 6/10
dose 0.7 g/kg bw = 9/10
dose 0.8 g/kg bw = 10/10 - Clinical signs:
- other: no signs observed in 0.3 g/kg bw group all other groups showed increasing signs of diarrhoea, chromodakryorrhoe, bloody snout, face down position, reduced spontaneous activity, narkosis, paralysis of hint extremities
- Gross pathology:
- no findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Like other chloroanilines, the primary toxic effect of 3,4-dichloroaniline is methaemoglobin formation. Taking into account that humans are much more sensitive to methaemoglobin producing substances than rats and that sufficient results of studies with cats, better suited to judge the level of toxicity for humans, are not available, 3,4-dichloroaniline is classified as Toxicity Category III.
- Executive summary:
Löser, E, 1981, study report, Bayer AG
In this study 3,4-dichloroaniline was administered to groups of 10 male Wistar TNO W74 rats by oral gavage in doses of 0.3,0.5, 0.6, 0.7 or 0.8 g/kg body weight. Clinical signs of toxicity and mortality were documented. In the 0.3 g/kg bw group no toxixity was evident. All other groups showed increasing signs of toxicity including diarrhoea, chromodakryorrhoe, bloody snout, face down position, reduced spontaneous activity, narkosis, paralysis of hint extremities. Dead animals were found in those groups on the second or third day post-application. The calculated LD50 was 0.57 g/kg bw.
According to this study 3,4-dichloroaniline should be classified as harmful if swallowed.
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