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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Data is from study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Studies on the acute oral toxicity of 4-nitro-1,3-phenylenediamine in female Wistar rats
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 4-nitro-m-phenylenediamine
- Molecular formula (if other than submission substance): C6H7N3O2
- Molecular weight (if other than submission substance): 153.14 g/mole
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-nitro-m-phenylenediamine
- Molecular formula (if other than submission substance): C6H7N3O2
- Molecular weight (if other than submission substance): 153.14 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF rats (Wistar strain TNO W 74, Ztichter: Winkelmann, Borchen)
- Age at study initiation: approximately 14 weeks old
- Weight at study initiation: average initial weight of 171 g.
- Fasting period before study: Not reported
- Housing: Conventional cages in Makrolon type III in a dust-free wood pellets in groups of 5 animals
- Diet (e.g. ad libitum): altromin R 1324, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Not reported
- Identification: The identification of the animals was performed by picric acid marker of the skin and cage labeling

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 ° C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle (artificial lighting 7-19 hours)

IN-LIFE DATES: From: To: Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The substance was formulated at room temperature in water and administered by means of a rigid metal gavage at constant volume administered (20 ml / kg body weight) to 10 female animals/dose administered once.
Doses:
1000, 1500, 2000, 2500, 3100 mg/kg bw
No. of animals per sex per dose:
Totel: 50
1000 mg/kg bw: 10 female
1500 mg/kg bw: 10 female
2000 mg/kg bw: 10 female
2500 mg/kg bw: 10 female
3100 mg/kg bw 10 female
Control animals:
not specified
Details on study design:
On the day of application and in the following 14-day observation period, the animals were repeatedly inspected twice a day (once on weekends and holidays), for the nature, onset, duration and intensity of the clinical symptoms and possibly death.
Deaths and conclusion of the test animals slaughtered were randomly dissected
During the application and at the end of the 14 day observation period, the animals were weighed individually about living.
Statistics:
The calculation of the LD50 with the confidence interval for p <0.05 was carried out with the programmed probit analysis by Fink and Hund

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 650 mg/kg bw
Based on:
test mat.
95% CL:
1 380 - 1 800
Remarks on result:
other: 50 % mortality observed
Mortality:
when treated with 3100 mg/kg bw, all animals died
when treated with 2500 mg/kg bw, 9 female rats were died.
when treated with 2000 mg/kg bw, 7 female rats were died.
when treated with 1500 mg/kg bw, 5 female rats were died.
when treated with 1000 mg/kg bw, No mortality were observed.
Clinical signs:
Anesthesia, tremors, shaggy coat, stomach side position, reduction of the general condition, sedation were observed in treated female rats.
Body weight:
weight loss were observed in treated female rats.
Gross pathology:
No macroscopically specific findings were observed in treated rats died during the experiment and some at the end of the experiment killed animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 was considered to be 1650 mg/kg (1380-1800) when SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine orally by gavage.
Executive summary:

In a acute oral toxicity study, SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine in the concentration of 1000, 1500, 2000, 2500, 3100 mg/kg bw orally by gavage. All animals died at 3100 mg/kg bw, 9 female rats were died at 2500 mg/kg bw, 7 female rats were died at 2000 mg/kg bw, 5 female rats were died at 1500 mg/kg bw and No mortality were observed at 1000 mg/kg bw. In addition, Anesthesia, tremors, shaggy coat, stomach side position, reduction of the general condition, sedation and weight loss were observed in treated female rats. No macroscopically specific gross findings were observed treated female rats. Therefore, LD50 was considered to be 1650 mg/kg (1380-1800) when SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine orally by gavage.