Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Done to guideline and GLP and acceptable for assessment

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
Dosing was on days 6-16 of pregnancy
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Analytical purity:98.5%
- Other: Blended commerical sample, purity 98.5%, from 4 manufacturers spray dried with gum Arabic at a concentration of 17.56 %

Test animals

Species:
rat
Strain:
other: CrL:COBS (CD) BR rats
Details on test animals and environmental conditions:
Not reported

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
Microencapsulation in Gum Arabic was used to prevent decreased food intake due to inappetence. Bioavailability was demonstrated in separate study (Hawkins et al., 1990).
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
Not reported
Duration of treatment / exposure:
Days 6-15 of pregnancy
Frequency of treatment:
daily
Duration of test:
20 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
83.1, 265.9 & 799.1 mg/kg
Basis:
other: Mean daily intakes during days of dosing
Remarks:
Doses / Concentrations:
0, 1000, 3000 & 5000 ppm resulting in intakes of about 83, 266 & 799 mg/kg day
Basis:
nominal in diet
No. of animals per sex per dose:
Not reported
Control animals:
other: Yes. Gum Arabic

Examinations

Maternal examinations:
Not reported
Ovaries and uterine content:
Not reported
Fetal examinations:
Not reported
Statistics:
Not reported
Indices:
Not reported
Historical control data:
Not reported

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
No effects at any dose

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
5 000 ppm (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
5 000 ppm (nominal)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No effects at any dose

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
There was no evidence of maternal or fetal toxicity at any dose level after dietary administration.