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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:
weight of evidence
Study period:
1975
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:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute oral toxicity or LD50 value was determined by oral administration of test substance to four dose groups of male rats. Animals were observed for mortality during the study period. The method followed in this study was comparable to the OECD guideline 401.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

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

Administration / exposure

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

MAXIMUM DOSE VOLUME APPLIED: Not reported

DOSAGE PREPARATION: Not reported
- Rationale for the selection of the starting dose: Not reported
Doses:
100, 200, 400 and 800 mg/kg bw
No. of animals per sex per dose:
5 males/ dose group
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
- Other examinations performed: Mortality

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
246 mg/kg bw
Based on:
test mat.
95% CL:
> 187 - < 325
Remarks on result:
other: LD50 was calculated by Weil Method (Biometrics, Sept. 1952)
Mortality:
Mortality observed at individual dose levels was as follows:
- 100 mg/kg bw: 0/5
- 200 mg/kg bw: 1/5
- 400 mg/kg bw: 5/5
- 800 mg/kg bw: 5/5
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported

Any other information on results incl. tables

Calculation of LD50 by the Weil Method (Biometrics, Sep. 1952)

Dose level (mg/kg bw)      Mortality

100                                          0/5

200                                          1/5

400                                          5/5

800                                          5/5

Constant ratio = 2.0

Da = Lowest dose level

d = log of constant

f = 0.3

Delta f = 0.2

v values = 0, 1, 5, 5

For K =3

Log M = log Da + d (f+1)

Log M =0 + 0.3010 (0.3+1)

Log M = 0 + 0.3010 (1.3)

Log M = 0.3913

Antilog of M = 246.2 (LD50)=246

 Log of confidence limits = log M ± 2d (delta f)

                                = 0.3913± 2 (0.3010) (0.2)

                               = 0.3913± 0.1204

                                =0.5117 ± 0.2709

Antilog 0.5117 = 324.8

Antilog 0.2709= 186.6

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute oral LD50 of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate was determined to be 246 mg/kg bw (95% CL: 187-325) when administered at dose levels of 100, 200, 400 and 800 mg/kg bw in male rats.
This test substance was therefore classified as OECD GHS Toxicity Category III (Toxic if swallowed).
Executive summary:

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

A total of 20 male rats weighing 250-300 g were divided into four different treatment groups containing 5 rats each. The test substance was prepared in dimethyl sulfoxide (DMSO; 10%) and administered orally at dose levels of 100, 200, 400 and 800 mg/kg bw.

During the study period animals were observed for mortality.

All the animals in dose groups 400 and 800 mg/kg bw died during the study period. During the study, one of 200 mg/kg bw died during the study period. No mortality was observed at dose level of 100 mg/kg bw throughout the observation period. Clinical signs were not reported in the study.

LD50 of test substance was calculated by the Weil Method (Biometrics, Sep. 1952) and was determined to be 246 mg/kg bw with 95% confidence limit of 187-325.

Based on above, the acute oral LD50 of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate was determined to be 246 mg/kg bw (95% CL: 187-325) when administered at dose levels of 100, 200, 400 and 800 mg/kg bw in male rats.