Registration Dossier
Registration Dossier
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EC number: 252-652-2 | CAS number: 35642-64-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from EFSA journal.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the food colour Red 2G (E128) based on a request from the Commission related to the re-evaluation of all permitted food additives
- Author:
- European Food Safety Authority
- Year:
- 2 007
- Bibliographic source:
- The EFSA Journal (2007) 515, 1-28
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The subchronic repeated dose toxicity study of Red 2G (CAS No.- 3734-67-6) in mice was conducted to evaluate adverse effects by oral route.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 223-098-9
- EC Name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3734-67-6
- Molecular formula:
- C18H13N3Na2O8S2
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- C.I. Acid Red 1
- IUPAC Name:
- C.I. Acid Red 1
- Details on test material:
- - Name of test material (as cited in study report): Red 2G- Molecular formula (if other than submission substance): C18H15N3O8S2.2Na- Molecular weight (if other than submission substance): 509.426 g/mol- Substance type: Organic- Physical state: No data avaialble - Impurities (identity and concentrations): Purity: 85.9%Impurity: Water insoluble material 0.06%, Ether extractable material 0.01%, Subsidiary dye 1.0%, Arsenic, Lead <5ppm, Copper <5ppm
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Three months.
Doses / concentrations
- Remarks:
- 0, 0.01, 0.1, 1, or 2% Red 2G (equivalent to 14, 143, 1429, or 2858 mg/kg bw).
- No. of animals per sex per dose:
- Five groups of 15 male and 15 female mice were used.
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
- Time schedule: Not specified
- Cage side observations checked in table [No.?] were included. Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY: Not specified
- 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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined:Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 5 animals per group
- Parameters checked in table [No.?] were examined. Not specified
CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood:Not specified
- Animals fasted: Not specified
- How many animals:Not specified
- Parameters checked in table [No.?] were examined.Not specified
URINALYSIS: Not specified
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined.Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations:Not specified
- Dose groups that were examined:Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other:Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations:Not specified
- How many animals:Not specified
- Dose groups that were examined:Not specified
- Parameters checked in table [No.?] were examined.Not specified - Sacrifice and pathology:
- Five mice of each sex at each dose level were killed at 26, 55 and 96 days.
GROSS PATHOLOGY: Not specified
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 0.1, 1.0 and 2.0% a dose-related decrease in Hb, RBC and PCV was seen, with some compensation for red cell loss at three months. A dose-related increase in reticulocytes, Heinz bodies, anisocytosis, polychromasia, poikilocytosis and marrow reaction was seen.
Splenomegaly was observed in both sexes at 2% and in females at 1%. - Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A temporary effect on the relative spleen weight was seen at 0.1 and 1.0% in both sexes at 26 and 55 days.
Relative liver weights were increased in females at 1% and 2% at day 26, and at 2% at days 55 and 96.
Significant increases in kidney weight were also noted, being temporary at days 26 and 55 at the doses of 0.01, 0.1 and 1.0% but in females present at 2.0% at 96 days. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Haemosiderin was increased in the liver (Kupffer cells) at 1% and 2%. In the spleen haemosiderin was increased at 2% at all test days, and at the other concentrations increased with treatment and duration.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 143 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- other: No adverse effects were evident.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study,the no-observed adverse effect level (NOAEL) of Red 2G (CAS No.- 3734-67-6) in this subchronic study in mice was observed to be 143.0 mg/kg bw.
- Executive summary:
The subchronic repeated dose toxicity study of Red 2G (CAS No.- 3734-67-6) in mice was conducted to evaluate the adverse effects by oral route. Five groups of 15 male and 15 female mice were given diets containing 0, 0.01, 0.1, 1, or 2% Red 2G (equivalent to 14, 143, 1429, or 2858 mg/kg bw) for three months. 5 animals per group were haematologically investigated and fully autopsied at days 26, 55, and 96. A dose- dependent increase in the incidence of Heinz bodies was observed. Splenomegaly was observed in both sexes at 2% and in females at 1%. Relative liver weig hts were increased in females at 1% and 2% at day 26, and at 2% at days 55 and 96. Haemosiderin was increased in the liver (Kupffer cells) at 1% and 2%. In the spleen haemosiderin was increased at 2% at all test days, and at the other concentrations increased with treatment and duration. No adverse effects on growth or food consumption were evident. Thus under the condition of the study, the no-observed adverse effect level (NOAEL) of Red 2G (CAS No.- 3734-67-6) in this subchronic study in mice was observed to be 143.0 mg/kg bw.
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