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Toxicological information

Acute Toxicity: oral

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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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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 %

Test animals

Species:
rat
Strain:
other: Wistar TNO W 74
Sex:
male
Details on test animals 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:
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
Body weight:
no data
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.