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Diss Factsheets

Administrative data

Description of key information

The acute oral toxicity dose (LD50) was considered to be >5000 mg/kg bw, when groups of 5 male and 5 female Wistar rats were treated with the given test chemical via oral gavage route.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Weight of evidence approach based on the available data of the read-across chemicals.
Justification for type of information:
Weight of evidence approach based on the available data of the 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 Acute oral study for read across chemicals.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
other:
Remarks:
2. Wistar 3. Not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
2. TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent,
- Weight at study initiation: weight-range of 137 - 159 g for males; and 126 - 143 g for females.
- Fasting period before study: Rats were deprived of food for 16 hours before dosing.
- Housing:Animals were housed throughout in suspended polypropylene cages with grid mesh floors.
- Diet (e.g. ad libitum): pelleted rodent diet, ad libitum
- Water (e.g. ad libitum):tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 degree ± 2 degree C
- Photoperiod (hrs dark / hrs light): 12-hour lighting cycle during a minimum period of seven days.

3.No data available
Route of administration:
other: 2. Gavage 3. Not specified
Vehicle:
other: 2. aqueous solution 3.Not specified
Details on oral exposure:
2. VEHICLE
- Concentration in vehicle: 50% w/v
- Amount of vehicle (if gavage):10 ml/kg

3. No data available
Doses:
2. 5000 mg/kg bw
3. 7460 mg/kg bw
No. of animals per sex per dose:
2. groups of 5 male and 5 female rats
3. No data available
Control animals:
not specified
Details on study design:
2.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were closely observed throughout the first hour for signs of reaction to the administered material, followed by examination at regular intervals for the remainder of the day. Subsequently, until termination, they were examined at least daily. The time-course of reaction to treatment and subsequent recovery was assessed subjectively by visual appraisal of the animals and, more objectively, by examination of the bodyweight changes 7 and 14 days after dosing.
- Necropsy of survivors performed: yes, all animals that died were subjected to thorough necropsy with the objective of locating target tissues damaged by the test material. Animals which survived to Day 15 were killed and similarly examined to assess any residual or delayed pathology.
- Other examinations performed: Signs of reaction and mortalities were recorded during a 14-day observation period.

3. No data available
Statistics:
not specified
Preliminary study:
2. Two rats of each sex were employed in preliminary range finding studies at the maximum required dosage of 5000 mg/kg.No signs of reaction to treatment were observed during a preliminary study. Bright orange coloured faeces were present on Days 2 and 4. Necropsy on Day 15 revealed no abnormalities,except for orange-colouration of the kidneys.
3. No data available
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Remarks:
2
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 7 460 mg/kg bw
Based on:
test mat.
Remarks on result:
other: : 50% mortality was observed at dose 7460 mg/kg bw
Remarks:
3
Mortality:
2. No mortality was observed at 5000 mg/kg bw.
3. 50% mortality was observed at dose 7460 mg/kg bw
Clinical signs:
other: 2. The overt signs of reaction to treatment comprised piloerection at 1-2.5 hours after treatment and a decrease in motor activity over the period 0.5 - 6 hours, in all animals. The presence of bright-red pigmented faeces from the day of dosing to Day 3 p
Gross pathology:
2. Terminal necropsy on Day 15 revealed no significant lesions that could be attributable to treatment; however, the renal cortices were stained slight orange, showing some deposition of material.
3. No data available
Other findings:
2. Under the conditions of this study, test chemical was absorbed sufficiently to produce, in all animals, minor signs of reaction to treatment. Staining of the renal cortices afforded evidence of urinary excretion.
3. No data available
Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be >5000 mg/kg bw, when groups of 5 male and 5 female Wistar rats were treated with the given test chemical via oral gavage route.
Executive summary:

The acute oral toxicity study was conducted in wistar rats by using test chemical at the dose concentration of 5000 mg/kg bw. The given test chemical (Procion Orange H-ER, ORG/98, Code B6100 Z0593, a powder) was prepared for administration as a 50% w/v aqueous solution but dosages were expressed gravimetrjcally. Dosages were determined according to the fasted body weight of the animals, which were dosed orally at approximately 11.00 hours with a dosage volume of 10 ml/kg. In preliminary range finding studies, 2 rats of each sex were employed at the maximum required dosage of 5000 mg/kg. No signs of reaction to treatment were observed during a preliminary study. Bright orange coloured faeces were present on Days 2 and 4. Necropsy on Day 15 revealed no abnormalities, except for orange-colouration of the kidneys. In main study, the animals were closely observed throughout the first hour for signs of reaction to the administered material, followed by examination at regular intervals for the remainder of the day. Subsequently, until termination, they were examined at least daily. The time-course of reaction to treatment and subsequent recovery was assessed subjectively by visual appraisal of the animals and, more objectively, by examination of the bodyweight changes 7 and 14 days after dosing. All animals that died were subjected to thorough necropsy with the objective of locating target tissues damaged by the test material. Animals which survived to Day 15 were killed and similarly examined to assess any residual or delayed pathology. Signs of reaction and mortalities were recorded during a 14-day observation period. No mortality was observed at 5000 mg/kg bw. The overt signs of reaction to treatment comprised piloerection at 1-2.5 hours after treatment and a decrease in motor activity over the period 0.5 - 6 hours, in all animals. The presence of bright-red pigmented faeces from the day of dosing to Day 3 probably indicated poor absorption of the dose. Animals gained weight normally over the period of observation. Terminal necropsy on Day 15 revealed no significant lesions that could be attributable to treatment; however, the renal cortices were stained slight orange, showing some deposition of material. Under the conditions of this study, test chemical was absorbed sufficiently to produce, in all animals, minor signs of reaction to treatment. Staining of the renal cortices afforded evidence of urinary excretion. Hence, the LD50 value considered to be >5000 mg/kg bw, when groups of 5 male and 5 female Wistar rats were treated with the given test chemical via oral gavage route.

In another study, Acute oral toxicity study was done in rats using test material. 50%  mortality was observed at dose 7460 mg/kg bw. Hence,LD50 value was considered to be 7460 mg/kg bw,when rats were treated with test chemical orally.

Based on the above two studies it is concluded that LD50 value of the test chemical is >2000 mg/kg bw and not classified in Nature.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
K2

Additional information

Acute oral toxicity:

The acute oral toxicity study was conducted in wistar rats by using test chemical at the dose concentration of 5000 mg/kg bw. The given test chemical (Procion Orange H-ER, ORG/98, Code B6100 Z0593, a powder) was prepared for administration as a 50% w/v aqueous solution but dosages were expressed gravimetrjcally. Dosages were determined according to the fasted body weight of the animals, which were dosed orally at approximately 11.00 hours with a dosage volume of 10 ml/kg. In preliminary range finding studies, 2 rats of each sex were employed at the maximum required dosage of 5000 mg/kg. No signs of reaction to treatment were observed during a preliminary study. Bright orange coloured faeces were present on Days 2 and 4. Necropsy on Day 15 revealed no abnormalities, except for orange-colouration of the kidneys. In main study, the animals were closely observed throughout the first hour for signs of reaction to the administered material, followed by examination at regular intervals for the remainder of the day. Subsequently, until termination, they were examined at least daily. The time-course of reaction to treatment and subsequent recovery was assessed subjectively by visual appraisal of the animals and, more objectively, by examination of the bodyweight changes 7 and 14 days after dosing. All animals that died were subjected to thorough necropsy with the objective of locating target tissues damaged by the test material. Animals which survived to Day 15 were killed and similarly examined to assess any residual or delayed pathology. Signs of reaction and mortalities were recorded during a 14-day observation period. No mortality was observed at 5000 mg/kg bw. The overt signs of reaction to treatment comprised piloerection at 1-2.5 hours after treatment and a decrease in motor activity over the period 0.5 - 6 hours, in all animals. The presence of bright-red pigmented faeces from the day of dosing to Day 3 probably indicated poor absorption of the dose. Animals gained weight normally over the period of observation. Terminal necropsy on Day 15 revealed no significant lesions that could be attributable to treatment; however, the renal cortices were stained slight orange, showing some deposition of material. Under the conditions of this study, test chemical was absorbed sufficiently to produce, in all animals, minor signs of reaction to treatment. Staining of the renal cortices afforded evidence of urinary excretion. Hence, the LD50 value considered to be >5000 mg/kg bw, when groups of 5 male and 5 female Wistar rats were treated with the given test chemical via oral gavage route.

In another study, Acute oral toxicity study was done in rats using test material. 50%  mortality was observed at dose 7460 mg/kg bw. Hence,LD50 value was considered to be 7460 mg/kg bw,when rats were treated with test chemical orally.

Based on the above two studies it is concluded that LD50 value of the test chemical is >2000 mg/kg bw and not classified in Nature.

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 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.