Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate

Endpoint summary

Description of key information

The test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

sub-chronic 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 publication

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Subchronic toxicity study was performed to evaluate the toxic nature of the test compound disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate upon repeated application by the oral route of exposure.

GLP compliance:

no

Limit test:

yes

Species:

pig

Strain:

other: SPF pigs of Danish Landrace

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

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

IN-LIFE DATES: From: To: No data available

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: No data available

DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available

VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

77 days

Frequency of treatment:

daily

Remarks:

Doses / Concentrations:
1000 & 1500mg/kg
Basis:
actual ingested

No. of animals per sex per dose:

2 male and female

Control animals:

yes

Details on study design:

Details on study design
- Dose selection rationale: No data available
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available

Positive control:

No data

Observations and examinations performed and frequency:

Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes- daily
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined:

HAEMATOLOGY: Yes
- Time schedule for collection of blood: From truncus jugularis 2 days prior to and 5, 19 and 68 days following the start of the dosing period.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined.

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined:
- Battery of functions tested: No data sensory activity / grip strength / motor activity / other: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

No data

Statistics:

No data

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Description (incidence and severity):

No significant effect observed

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

No significant effect observed

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

No data

Dose descriptor:

NOAEL

Effect level:

1 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No any significant toxic effects on the examined liver and blood parameters.

Critical effects observed:

not specified

Conclusions:

In conclusion, there is no any significant toxic effects on the examined liver and blood parameters were observed at dose level. Therefore the NOAEL value is 1500mg/kg/day.

Executive summary:

Sub chronic repeated dose toxicity test was carried out with 2 male and 2 female SPF pigs of Danish Landrace to evaluate the toxic nature of the test compound Fast Yellow AB upon repeated application by the oral route of exposure. All pigs are dosed with 1000mg/kg or 1500mg/kg by gavage for total 77 days. Hematological examinations were performed at intervals and organ histopathology was performed at necropsy. No effects were detected and no Heinz bodies were found in the red blood cells. There were no significant toxic effect on the clinical & hematological parameters and on the examined liver and blood parameters. Therefore the No Observed Adverse Effect Level (NOAEL) value was reported to be 1500mg/kg/day. Thus the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 500 mg/kg bw/day

Study duration:

subchronic

Species:

pig

Quality of whole database:

Data is from K2 peer reviewed publication

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity: Oral

Data from the test chemical studies and read across data have been reviewed to determine the toxic nature of the test compound upon repeated exposure by the oral route. The summary is as mentioned below:

Sub chronic repeated dose toxicity test was carried out by Sondergaard et al (1977) with 2 male and 2 female SPF pigs of Danish Landrace to evaluate the toxic nature of the test compound Fast Yellow AB upon repeated application by the oral route of exposure. All pigs are dosed with 1000mg/kg or 1500mg/kg by gavage for total 77 days. Hematological examinations were performed at intervals and organ histopathology was performed at necropsy. No effects were detected and no Heinz bodies were found in the red blood cells. There were no significant toxic effect on the clinical & hematological parameters and on the examined liver and blood parameters. Therefore the No Observed Adverse Effect Level (NOAEL) value was reported to be 1500mg/kg/day. Thus the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.

Based on the available data summarized, the test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

Data is from peer reviewed publication

Justification for classification or non-classification

Based on the available data summarized, the test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.