Registration Dossier

Administrative data

Description of key information

The compound, 2-nitro-p-phenylenediamin, was administered orally in an oil-in-water emulsion by stomach tube to groups of ten fasted Charles River CD rats (five males and five females per group).The LD50's were calculated by the method of Weil (1952).
The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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: Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study for the test compound was conducted on groups of ten fasted Charles River CD rats. The LD50's were calculated by the method of Weil
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River- Weight at study initiation: 200-300g- Fasting period before study: fasted- Housing: No data- Diet (e.g. ad libitum): No data- Water (e.g. ad libitum): No data- Acclimation period: No data
Route of administration:
oral: gavage
Vehicle:
other: Oil-in water emulsion
Details on oral exposure:
No data
Doses:
No data
No. of animals per sex per dose:
five males and five females
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days (or other?): No dataFrequency of observations and weighing: No dataNecropsy of survivors performed: yes/no: YesOther examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data
Statistics:
The LD50 and its 95% confidence limits were calculated from the mortality data by the method of Weil (1952).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 080 mg/kg bw
Based on:
test mat.
95% CL:
2 130 - 4 460
Remarks on result:
other: 50 % mortality

Acute Toxicity of Hair Dyes

 

LD50 in rats

Compound

Oral (mg/kg)

95% confidence limits

2-Nitro-pphenylenediamine

3080

2130-4460

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.
Executive summary:

In a acute oral toxicity study, Charles River CD rats were treated with 2-nitro-p-phenylenediamin in Oil-in water emulsion. The LD50's were calculated by the method of Weil (1952).The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 080 mg/kg bw
Quality of whole database:
Data is from peer reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: Oral

In a study conducted by Burnettet al, (1977), acute oral toxicity was evaluated in Charles River CD rats by using 2-nitro-p-phenylenediamin in Oil-in water emulsion. The LD50's were calculated by the method of Weil (1952).The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.

In a study conducted by Lloydet al, (1977), acute oral toxicity was evaluated in CFY male and female rats by using 2-nitro-p-phenylenediamin orally. Mortality was observed at 1800 mg/kg bw. Signs of reaction to treatment, observed shortly after dosing are lethargy and piloerection. Other reactions elicited by test compound included increased salivation, ataxia, fine body tremors, changes in respiratory rate, diuresis and diarrhea. In addition, red staining of the internal organs were observed. Therefore, LD50 and its 95% confidence limits was 1800 (1500 - 2300) mg/kg bw when CFY male and female rats were treated with 2-nitro-p-phenylenediamin.

In a Final Report on the Safety Assessment of 2-Nitro-p-Phenylenediamine given by COSMETIC INGREDIENT REVIEW PANEL (1985), acute oral toxicity was evaluated in male rats by using 2-nitro-p-phenylenediamin orally in water and observed for 8 days. 50 % mortality was observed at 2100 mg/kg bw. Therefore, LD50 was considered to be 2100 mg/kg bw when male rats treated with 2-nitro-p-phenylenediamin orally.

In the above similar report, acute oral toxicity was evaluated in male and female rats by using 2 nitro p phenylenediamine orally in oil-in water emulsion LD50 was found to be 3080 mg/kg bw when male and female rats were treated with 2 nitro p phenylenediamine.

Based on the Danish (Q) SAR Database (2016), estimated acute oral LD50 value of substance 2-nitro-p-phenylenediamine was considered to be1700 Mg/kg in rat.

Thus, one the basis of above data, test chemical 2 nitro p phenylene diamine (5307-14-2) as per the CLP classification was likely to be non hazardus by oral route.


Justification for selection of acute toxicity – oral endpoint
The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material.

Justification for classification or non-classification

2 - nitro p phenylene diamine (5307-14-2) as per the CLP classification was likely to be non hazardus by oral route.