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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
multi-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
secondary source
Title:
A Multigeneration Study in Rats of D&C Red 33 in the Diet
Author:
International Research and Development Corporation
Year:
2007
Bibliographic source:
Scientific Committee on Consumer Products (SCCP), OPINION ON Acid Red 33, COLIPA n° C22, 2007 page no -19

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Principles of method if other than guideline:
Multigeneration Study of D&C Red 33 in rats
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
EC Number:
222-656-9
EC Name:
Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Cas Number:
3567-66-6
Molecular formula:
C16H13N3O7S2.2Na
IUPAC Name:
disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
Constituent 2
Reference substance name:
D&C Red 33
IUPAC Name:
D&C Red 33
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): D&C Red 33- Molecular formula (if other than submission substance): C16H11N3Na2O7S2- Molecular weight (if other than submission substance): 467 g/mole- Substance type: Organic- Physical state: Powder- Impurities (identity and concentrations): No data available

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: No data available - Age at study initiation: (P) x wks; (F1) x wks: No data available - Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g: No data available - Fasting period before study: No data available - Housing: No data available - Diet (e.g. ad libitum): Purina Rodent Chow 5002, ad libitum- 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

Administration / exposure

Route of administration:
oral: feed
Type of inhalation exposure (if applicable):
not specified
Vehicle:
other: Purina Rodent Chow 5002
Details on mating procedure:
Details on study scheduleF0: 20 animals per sex per dose levelF1a: mating on day 100F1b and F1c: mating at least 10 day laterF2a: mating of 20 F1 animals randomly selectedF3: mating of 20 F2b litters - 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:: F0 parental animals were mated twice (each group 20 males and 20 females), to produce two litters and the F1 parents were mated to produce three litters and the F2 parents were mated once to produce the F3a litters.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
110 days and more
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:0, 0.25, 2.5, 7.5 and 25.0 mg/kg bw/day Basis:
No. of animals per sex per dose:
Total: 600F0 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 femaleF1 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 femaleF2 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 female
Control animals:
yes, concurrent vehicle
Details on study design:
No data available
Positive control:
No data available

Examinations

Parental animals: Observations and examinations:
Survival, clinical sign, Body weight and food consumption were examined.
Oestrous cyclicity (parental animals):
No data available
Sperm parameters (parental animals):
No data available
Litter observations:
Survival, clinical sign, Body weight and food consumption were examined.
Postmortem examinations (parental animals):
Histopathology were examined.
Postmortem examinations (offspring):
Histopathology were examined.
Statistics:
No data available
Reproductive indices:
Fertility indices, gestation anomalies, viability and survival of the pups were examined.
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:
not specified
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:
no effects observed

Details on results (P0)

Mortality: No effect on survival of treated rats were observed as compared to control. Clinical signs: When treated with 25 mg/kg bw/day, discoloration (pink or reddish) of the urine were observed in treated male and female rats as compared to control.Body weight: No effect on body weight of treated rats was observed as compared to control. Food consumption:No effect on food consumption of treated rats was observed as compared to control. Test substance intake: No data available Reproductive function: estrous cycle: No data available Reproductive function: sperm measures: No data available Reproductive performance: No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in treated rats as compared to control. Organ weightsNo data available Gross pathology: No data available Histopathology: No histopathological changes were observed intreated rats as compared to control.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
no effects observed

Details on results (F1)

Mortality: No effect on survival of treated F1 and F2 pups were observed as compared to control. Clinical signs: When treated with 25 mg/kg bw/day, discoloration (pink or reddish) of the urine were observed in F1 and F2 treated male and female pups as compared to control.Body weight: No effect on body weight of F1 and F2 treated male and female pups were observed as compared to control.Food consumption: No effect on food consumption of treated F1 and F2 rats were observed as compared to control. Test substance intake:No data available Reproductive function: estrous cycle@ No data available Reproductive function: sperm measures: No data available Reproductive performance: No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in treated rats as compared to control. Organ weightsNo data available Gross pathology:No data available Histopathology: In F2a generation, 1 pup had exencephaly, spina bifida and great vessel anomalies which was considered an incidental finding.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 25 mg/kg bw/day when Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33.
Executive summary:
In a Multigeneration Study,Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33 in the concentration of 0, 0.25, 2.5, 7.5 and 25.0 mg/kg bw/day orally in deit. No effect on survival of F0, F1 and F2 generation were observed. Discoloration (pink or reddish) of the urine were observed in F0, F1 and F2 treated male and female rats as compared to control. Similaly, no effect on body weight and food consumption of treated F0, F1 and F2 rats were observed as compared to control.No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in F0, F1 and F2treated rats as compared to control. In addition no effect on histopathology of F0 and F1 trated rats were observed. In F2a generation, 1 pup had exencephaly, spina bifida and great vessel anomalies which was considered an incidental finding.Therefore,NOAEL was considered to be 25 mg/kg bw/day when Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33.