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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Body weight was determined only before the start of the study
Principles of method if other than guideline:
BASF-TEST: Young adult laboratory rats were purchased from breeder. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4,4'-Diaminodiphenylemethane
- Purity: >= 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF-breed: Wiga, Sulzfeld, Germany
- Weight at study initiation: male 195 g/ female 170 g
- Diet: Altromin-R, Lage, Germany, ad libitum
- Water: ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
4% suspension (W/V) in 0.5% carboxymethyl cellulose
Doses:
250, 400, 500, 640 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Mortality: after 1, 24, and 48 hours and after 7 and 14 days.
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
Determination of LD50 according to Litchfield and Wilcoxon

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
444 mg/kg bw
95% CL:
398 - 495
Mortality:
No mortalities were observed at 250 mg/kg bw.
At 400 mg/kg bw mortalities were observed 48 h after application.
At the 500 - 640 mg/kg bw mortalities were observed within the first 24 h (see table 1).
Clinical signs:
400 - 640 mg/kg bw:
- apathy
- ataxia
- abdominal position
- dyspnea
- after 5-7 days disappearance of clinical signs

250 mg/kg bw:
- slight apathy, at day 2 no findings
Body weight:
no data
Gross pathology:
Animals which died:
- acute, obstructive hyperaemia, acute dilation of the heart, slight oedema of the lungs, hydrothorax and bloody ulceration of the stomach
Sacrificed rats at 400 -500 mg/kg bw.:
-pinhead-sized, grey, and in part, aggregating bodies in the liver, and splenomegaly.
Sacrificed rats at 250 mg/kg bw.:
- no pathological effects

Any other information on results incl. tables

Table 1: Mortality of animals after treatment with Phenylbase.

250 mg/kg bw 400 mg/kg bw 500 mg/kg bw 640 mg/kg bw
male female male female male female male female
1 h 0/5 0/5 0/5 0/5 0/5 0/5 0/5 0/5
1 d 0/5 0/5 0/5 0/5 1/5 3/5 5/5 5/5
2 d 0/5 0/5 0/5 1/5 2/5 5/5 5/5 5/5
7 d 0/5 0/5 0/5 2/5 3/5 5/5 5/5 5/5
14 d 0/5 0/5 0/5 2/5 3/5 5/5 5/5 5/5

Applicant's summary and conclusion