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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: Chronic
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

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:
Chronic repeated dose oral toxicity study of RED 2G in rats
GLP compliance:
not specified

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:
C18H15N3O8S2.2Na
IUPAC Name:
disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 2
Reference substance name:
Red 2G
IUPAC Name:
Red 2G
Details on test material:
- Name of test material (as cited in study report): RED 2G- Molecular formula (if other than submission substance): C16-H12-N2-O4-S.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

Test animals

Species:
rat
Strain:
not specified
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:
No data available
Details on mating procedure:
Details on study schedule- F1 parental animals not mated until [...] weeks after selected from the F1 litters.- Selection of parents from F1 generation when pups were [...] days of age.- Age at mating of the mated animals in the study: [...] weeks(Explain how study was performed on perents and offspring separately whatever information we have): No data available- M/F ratio per cage::No data available - Length of cohabitation::No data available - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data available - After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.:No data available - Further matings after two unsuccessful attempts: [no / yes (explain)]:No data available - After successful mating each pregnant female was caged (how)::No data available - Any other deviations from standard protocol:: Reproductive organ weight was weighted.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:0, 24 and 114 ppm (0, 2.4 and 11.4 mg/kg bw/day)Basis:
No. of animals per sex per dose:
Total:1440 mg/kg bw/day: 24 mal;e , 24 female 2.4 mg/kg bw/day: 24 mal;e , 24 female11.4 mg/kg bw/day: 24 mal;e , 24 female
Control animals:
yes, concurrent vehicle
Details on study design:
No data available
Positive control:
No data available

Examinations

Parental animals: Observations and examinations:
Clinical sign, body weight, Food intake, haematology, clinical chemistry and refractive index of the urine were examined.
Oestrous cyclicity (parental animals):
No data available
Sperm parameters (parental animals):
No data available
Litter observations:
No data available
Postmortem examinations (parental animals):
Organ function and weight, and histopathology were examined.
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
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
not specified

Reproductive function / performance (P0)

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

Details on results (P0)

Mortality: No data availableClinical signs: No effect on growth of treated rats were observed as compared to control. Loss of hair in many treated rats were observed.Body weight and food consumption: No data availableTest substance intake: No data availableReproductive function: estrous cycle: No data availableReproductive function: sperm measures: No data availableReproductive performance: No data availableOrgan weightsNo effect on spleen, kidneys, liver, heart and testes weight were observed in treated rats as compared to control. Gross pathology: No data availableHistopathology: Whne treated with 11.4 mg/kg bw/day, 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. other findingsClinical chemistry: No effect on liver function test (bromosulfthalein retention test) were observed in treated rats as compared to control.

Effect levels (P0)

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

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified

Effect levels (F1)

Remarks on result:
not determinable

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 11.4 mg/kg bw/day for male rats when male and female rats were treated with RED 2G.
Executive summary:

In Chronic repeated dose oral toxicity study, male and female rats were treated with RED 2G in the concentration of 0, 24 and 114 ppm in cooked sausage. No effect obn 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 and 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 but no effect were observed on testes of male rats. Therefore, NOAEL was considered to be 11.4 mg/kg bw/day for male rats when male and female rats were treated with RED 2G orally in deit for 13 weeks.