Registration Dossier
Registration Dossier
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EC number: 259-134-5 | CAS number: 54381-16-7
Acute Toxicity: other routes
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- 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 substance name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- EC Number:
- 259-134-5
- EC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Cas Number:
- 54381-16-7
- Molecular formula:
- C10H16N2O2.H2O4S
- IUPAC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Reference substance name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- 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.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system 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.
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