9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium acetate

Endpoint summary

Description of key information

Acute oral toxicity: The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

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 from various test chemicals

Justification for type of information:

Data is summarized based on the available information from various read across test 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 2 acute oral toxicity studies as - WoE 2 and WoE 3
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.

GLP compliance:

not specified

Test type:

other: Acute oral toxicity

Limit test:

yes

Specific details on test material used for the study:

No data available

Species:

other: 2. Rat 3. Mice

Strain:

other: 2. Sprague-Dawley 3.Not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

2.TEST ANIMALS
- Source:
No data
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
No data
- Age at study initiation:
No data
- Weight at study initiation:
No data
- Fasting period before study:
No data
- Housing:
No data
- Diet (e.g. ad libitum):
Rat pellets
- Water :
Distilled water ad libitum
- Acclimation period:
No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
No data
- Humidity (%):
No data
- Air changes (per hr):
No data
- Photoperiod (hrs dark / hrs light):
No data

IN-LIFE DATES: From: To:No data
3.Not specified

Route of administration:

other: 2. Oral gavage 3.Not specified

Vehicle:

not specified

Details on oral exposure:

2.Maximum dose volume applied: 5000 mg/kg bw
3.Not specified

Doses:

2.5000 mg/kg bw
3.10300 mg/kg bw

No. of animals per sex per dose:

2.5000 mg/kg bw: 10 rats
Control: 10 rats
3.Not specified

Control animals:

yes

Details on study design:

2.- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined after 2 hours and daily for 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
3.No data available

Statistics:

No data available

Preliminary study:

No data available

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality observed

Remarks:

2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

10 300 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality observed

Remarks:

3

Mortality:

2.Death was observed in one animal at 48 hours and in a second animal at 72 hours.
3.50% mortality was observed in treated mice at dose 10300 mg/kg bw

Clinical signs:

other: 2.All animals exhibited a mild to moderate lethargic response accompanied with ataxia, dyspnea, abnormal righting reflex, muscular weakness, piloerection and diarrhea. This condition persisted for approximately seventy-two (72) hours. 3.No data available

Gross pathology:

2.Gross pathology of survivors revealed that all target organs (heart. lungs, spleen. kidneys, liver and gastro-intestinal tract) appeared normal with the exception of a mild renal vascularization.
3.No data available

Other findings:

2.Autopsies of expired animals revealed hyperemic lungs, nephritic kidneys, peripheral lobular hemorrhage of the liver and hemorrhagic gastro-intestinal tract.
3.No data available

Interpretation of results:

other: Not classified

Conclusions:

In a acute oral toxicity study, the LD50 value was considered to be >5000 mg/kg bw when test animals were treated with test chemical.

Executive summary:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for test chemical. The studies are summarized as below –

The acute oral toxicity study was performed on rats to determine the toxic nature of the test chemical. 10 Sprague-Dawley rats were treated with test chemical at a concentration of 5000 mg/kg bw by oral intubation route. All animals exhibited a mild to moderate lethargic response accompanied with ataxia, dyspnea, abnormal righting reflex, muscular weakness, piloerection and diarrhea. This condition persisted for approximately seventy-two (72) hours. The average weight gain of the surviving test animals was 67.3 grams and that of control animals was 70.4 grams and the average weight loss of expired test animals was 19.0 grams. Gross pathology of survivors revealed that all target organs (heart. lungs, spleen, kidneys, liver and gastro-intestinal tract) appeared normal with the exception of a mild renal vascularization. Death was observed in one animal at 48 hours and in a second animal at 72 hours. Autopsies of expired animals revealed hyperemic lungs, nephritic kidneys, and peripheral lobular hemorrhage of the liver and hemorrhagic gastro-intestinal tract. Therefore based on the above observations, LD50 was considered to be >5000 mg/kg bw when 10 Sprague-Dawley rats were treated with test chemical orally.

In another acute oral toxicity study,mice were treated with test chemical at a concentration of 10300 mg/kg bw orally. No mortality was observed in treated mice. Therefore,LD50 was considered to be10300 mg/kg bw when mice were treated with test chemical orally.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimish 2 and from authoritative database

Additional information

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for test chemical. The studies are summarized as below –

The acute oral toxicity study was performed on rats to determine the toxic nature of the test chemical. 10 Sprague-Dawley rats were treated with test chemical at a concentration of 5000 mg/kg bw by oral intubation route. All animals exhibited a mild to moderate lethargic response accompanied with ataxia, dyspnea, abnormal righting reflex, muscular weakness, piloerection and diarrhea. This condition persisted for approximately seventy-two (72) hours. The average weight gain of the surviving test animals was 67.3 grams and that of control animals was 70.4 grams and the average weight loss of expired test animals was 19.0 grams. Gross pathology of survivors revealed that all target organs (heart. lungs, spleen, kidneys, liver and gastro-intestinal tract) appeared normal with the exception of a mild renal vascularization. Death was observed in one animal at 48 hours and in a second animal at 72 hours. Autopsies of expired animals revealed hyperemic lungs, nephritic kidneys, and peripheral lobular hemorrhage of the liver and hemorrhagic gastro-intestinal tract. Therefore based on the above observations, LD50 was considered to be >5000 mg/kg bw when 10 Sprague-Dawley rats were treated with test chemical orally.

In another acute oral toxicity study,mice were treated with test chemical at a concentration of 10300 mg/kg bw orally. No mortality was observed in treated mice. Therefore,LD50 was considered to be10300 mg/kg bw when mice were treated with test chemical orally.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity and comes under "Not Classified" category.