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Description of key information

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6).The studies are as mentioned below:

1.Acute oral toxicity study was done in mouse using test chemical. No mortality was observed at dose 10000 mg/kg bw.Hence,LD50 was considered to be >10000 mg/kg body weight,when mouse was treated with test chemical orally.

2.Acute oral toxicity study was done in 5 male and 5 female Sprague Dawley using test chemical. The test material dissolved in water and administered by oral gavage route in dose concentration 2000 mg /kg bw. The dose was selected on the basis of preliminary study. All the animals were observed 1, 2and 4 hours after dosing and thereafter daily for 14 days.Body weights were recorded on days 1, 8 and 15 of the study. Macroscopic examination of main organs was performed after autopsy. No histological examinations were performed.No mortality was observed at dose 2000mg/kg bw.The only clinical sign was a pink discoloration of the skin, apparent from 1 hour to 7 days after dosing.Body weight gain was considered normal for the age and strain of rat. At autopsy an orange coloration of the mammary tissue and /or abdominal fat, attributed to the staining properties of the substance and not considered to be a toxic effect. The distribution and persistence of staining indicates that the substance has the potential to accumulate, at least at the high dose used in this acute study.Hence,LD50 was considered to be>2000mg/kg body weight. When male and female rats were treated with test chemical orally.

Thus, based on the above summarised studies,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)is not likely to be toxic atleast at the dose of >10000 mg/Kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two acute oral toxicity studies as-
1.and 2. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no
Species:
other: 1. mouse 2. rat
Strain:
other: 1.not specified 2.Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
other: 1. not specified 2.oral: gavage
Vehicle:
other: 1.not specified 2.water
Details on oral exposure:
No data available
Doses:
1.10000 mg/kg bw
2.2000 mg/kg bw
No. of animals per sex per dose:
1.no data available
2.Total:10
Male :5
Female:5
Control animals:
not specified
Details on study design:
1. No data available
2.Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 1, 2and 4 hours after dosing and thereafter daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights were observed. Histopathology: No histological examinations were performed.
Statistics:
No data available
Preliminary study:
1.No data available
2.The dose group was selected on the basis of a preliminary range-finding study in which rats were given the test compound in water at dose levels from 100 to 2000 mg/kg bw, one death was reported at 1000 mg/kg bw but the only reported clinical signs were dose-related pink skin tone due to the compound and the death was considered to be unrelated to treatment
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Mortality:
1.No mortality was observed at dose 10000 mg/kg bw
2.No mortality was observed at dose 2000 mg/kg bw
Clinical signs:
1.No data available
2. The only clinical sign was a pink discoloration of the skin, apparent from 1 hour to 7 days after dosing.
Body weight:
1.No data available
2.Body weight gain was considered normal for the age and strain of rat.
Gross pathology:
1.No data available
2.At autopsy an orange coloration of the mammary tissue and /or abdominal fat, attributed to the staining properties of the substance and not considered to be a toxic effect
Other findings:
1.No data available
2.The distribution and persistence of staining indicates that the substance has the potential to accumulate, at least at the high dose used in this acute study
Interpretation of results:
other: not classified
Conclusions:
The test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline (85750-13-6) is not likely to be toxic atleast in the dose of >10000 mg/Kg bw.
Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6).The studies are as mentioned below:

1.Acute oral toxicity study was done in mouse using test chemical. No mortality was observed at dose 10000 mg/kg bw.Hence,LD50 was considered to be >10000 mg/kg body weight,when mouse was treated with test chemical orally.

2.Acute oral toxicity study was done in 5 male and 5 female Sprague Dawley using test chemical. The test material dissolved in water and administered by oral gavage route in dose concentration 2000 mg /kg bw. The dose was selected on the basis of preliminary study. All the animals were observed 1, 2and 4 hours after dosing and thereafter daily for 14 days.Body weights were recorded on days 1, 8 and 15 of the study. Macroscopic examination of main organs was performed after autopsy. No histological examinations were performed.No mortality was observed at dose 2000mg/kg bw.The only clinical sign was a pink discoloration of the skin, apparent from 1 hour to 7 days after dosing.Body weight gain was considered normal for the age and strain of rat. At autopsy an orange coloration of the mammary tissue and /or abdominal fat, attributed to the staining properties of the substance and not considered to be a toxic effect. The distribution and persistence of staining indicates that the substance has the potential to accumulate, at least at the high dose used in this acute study.Hence,LD50 was considered to be>2000mg/kg body weight. When male and female rats were treated with test chemical orally.

Thus, based on the above summarised studies,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)is not likely to be toxic atleast at the dose of >10000 mg/Kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative database

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

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6).The studies are as mentioned below:

1.Acute oral toxicity study was done in mouse using test chemical. No mortality was observed at dose 10000 mg/kg bw.Hence,LD50 was considered to be >10000 mg/kg body weight,when mouse was treated with test chemical orally.

2.Acute oral toxicity study was done in 5 male and 5 female Sprague Dawley using test chemical. The test material dissolved in water and administered by oral gavage route in dose concentration 2000 mg /kg bw. The dose was selected on the basis of preliminary study. All the animals were observed 1, 2and 4 hours after dosing and thereafter daily for 14 days.Body weights were recorded on days 1, 8 and 15 of the study. Macroscopic examination of main organs was performed after autopsy. No histological examinations were performed.No mortality was observed at dose 2000mg/kg bw.The only clinical sign was a pink discoloration of the skin, apparent from 1 hour to 7 days after dosing.Body weight gain was considered normal for the age and strain of rat. At autopsy an orange coloration of the mammary tissue and /or abdominal fat, attributed to the staining properties of the substance and not considered to be a toxic effect. The distribution and persistence of staining indicates that the substance has the potential to accumulate, at least at the high dose used in this acute study.Hence,LD50 was considered to be>2000mg/kg body weight. When male and female rats were treated with test chemical orally.

Thus, based on the above summarised studies,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)is not likely to be toxic atleast at the dose of >10000 mg/Kg bw.

Justification for classification or non-classification

Based on the above experimental studies on 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline(85750-13-6)cannot be classified for acute oral toxicity.