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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Chronic
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Summary of toxicological data of certain food additives
Author:
WHO
Year:
1977
Bibliographic source:
WHO FOOD ADDITIVES SERIES NO. 12, INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION, 18-27 April 1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
A repeated dose oral toxicity study of RED 2G in rats.
GLP compliance:
not specified
Limit test:
no
Justification for study design:
No data available

Test material

Constituent 1
Chemical structure
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
Details on test material:
- Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): RED 2G
- Molecular formula : C16H12N2O4S.Na
- Molecular weight : 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
No data available
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Cooked sausage
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test material was mixed in a cooked sausage.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): Cooked sausage-
Storage temperature of food: No data availble
VEHICLE
- Justification for use and choice of vehicle (if other than water): Cooked sausage
- Concentration in vehicle: 0, 24 or 114 ppm
-Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Details on mating procedure:
No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Daily
Details on study schedule:
No data available
Doses / concentrations
Remarks:
Doses / Concentrations: 0, 24 or 114 ppm (equal to 0, 2.4 or 11.4 mg/kg bw/day)
No. of animals per sex per dose:
Total: 144 animals
Control: 24 males, 24 females
24 ppm; 24 males, 24 females
114 ppm: 24 males, 24 females
Control animals:
yes, concurrent vehicle
Details on study design:
No data available
Positive control:
No data available

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): weekly
- 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

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

OTHER:After 10-11 days of study initiation, the presence of Heinz bodies was controlled. A liver function test (bromosulfthalein retention test) was carried out after 9 weeks, and after 12 weeks the refractive index of the urine was measured. Prior to sacrifice, a detailed hematological investigation was done.
Oestrous cyclicity (parental animals):
No data available
Sperm parameters (parental animals):
No data available
Litter observations:
No data available
Postmortem examinations (parental animals):
SACRIFICE yes
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]

GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]At post-mortem, the weights of the spleen, kidneys, liver, heart and testes were determined. 

HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.: No data
Postmortem examinations (offspring):
No data available
Statistics:
No data available
Reproductive indices:
No data available
Offspring viability indices:
No data available

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
No effect on growth of treated rats were observed as compared to control. Loss of hair in treated rats were observed.
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No effects on growth was observed.
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):
Blood test revealed no evidence of toxicity.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
No effect on liver function test (bromosulfthalein retention test) were observed in treated rats as compared to control.
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
When treated 114 ppm, increased erythropoiesis, increased splenic red pulp hemosiderin and increased splenic red pulp reticular impregnation with iron were observed in treated rats as compared to control.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
114 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No adverse effect on reproductive organ weight.
Remarks on result:
other: No effects on reproductive organ weight

Target system / organ toxicity (P0)

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Results: F1 generation

Effect levels (F1)

Remarks on result:
not determinable

Overall reproductive toxicity

Reproductive effects observed:
not specified
Treatment related:
not specified
Relation to other toxic effects:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 114 mg/kg bw for male rats when male and female rats were treated with RED 2G for 13 weeks.
Executive summary:

In a repeated dose oral toxicity study, male and female rats were treated with RED 2G (3734 -67-6) in the concentration of 0, 24 or 114 ppm in cooked sausage. No effect on growth of treated rats were observed. Loss of hair in many treated rats were observed. No effect on liver function test (bromosulfthalein retention test) were observed in treated rats as compared to control. Similarly, no effect on spleen, kidneys, liver, heart or testes weight were observed in treated rats as compared to control. Increased erythropoiesis, increased splenic red pulp haemosiderin and increased splenic red pulp reticular impregnation with iron were observed in treated rats as compared to control. In addition, no effect was observed on testes weight of male rats. Therefore, NOAEL was considered to be 114 ppm for male rats when male and female rats were treated with RED 2G orally in diet for 13 weeks.