Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute intraperitoneal toxicity (LD50 value) was determined by intraperitoneal administration of test substance (at six dose levels) in male rats. Animals were observed for mortality during the study period.
GLP compliance:
no
Remarks:
Pre-GLP
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate
- TSIN: RM 119
No other information on details on test material was provided in the study report.

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 250-300 g
No other information on test animals was provided in the study report.

ENVIRONMENTAL CONDITIONS: No details on the environmental conditions were provided in the study report.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
DMSO
Remarks:
10%
Details on exposure:
VEHICLE: DMSO (10%)
No other information on vehicle was provided in the study report.

DOSAGE PREPARATION: Not reported
Doses:
16, 31, 62, 125, 250 and 500 mg/kg bw
No. of animals per sex per dose:
5 males/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: Not reported
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 - < 31 mg/kg bw
Based on:
test mat.
Mortality:
Mortality observed at individual dose levels was as follows:
- 16 mg/kg bw: 1/5
- 31 mg/kg bw: 4/5
- 62 mg/kg bw: 5/5
- 125 mg/kg bw: 4/5
- 250 mg/kg bw: 4/5
- 500 mg/kg bw: 5/5
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
- Organ weights: Not reported
- Histopathology: Not reported
- Potential target organs: Not reported

Applicant's summary and conclusion

Conclusions:
The acute intraperitoneal LD50 of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate (A050) was determined to be >16 and <31 mg/kg bw when administered at dose levels of 16, 31, 62, 125, 250 and 500 mg/kg bw in male rats.
Executive summary:

The objective of this study was to determine the acute intraperitoneal toxicity of N,N-Bis(2 -Hydroxyethyl)-p-Phenylenediamine Sulfate (A050) when administered once intraperitoneally to male rats. 

A total of 30 male rats weighing 250-300 g were divided into six different treatment groups containing 5 rats each. The test substance was prepared in dimethyl sulfoxide (DMSO; 10%) and administered intraperitoneally at dose levels of 16, 31, 62, 125, 250 and 500 mg/kg bw.

During the study period animals were observed for mortality.

1/5, 4/5, 5/5, 4/5, 4/5 and 5/5 animals at dose levels of 16, 31, 62, 125, 250 and 500 mg/kg bw were found dead during the study, respectively.

Based on above, the acute intraperitoneal LD50 of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate (A050) was determined to be >16 and <31 mg/kg bw when administered once at dose levels of 16, 31, 62, 125, 250 and 500 mg/kg bw in male rats.