Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
Deviations:
yes
Remarks:
- lacking methodological detail, fewer than 30 females used per dose level, & no positive or vehicle control for subacute test.
GLP compliance:
no
Remarks:
- study pre-dates GLP.
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sorbitol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Assigned to test groups randomly: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
A control group received 10 mL/kg; however, the vehicle that this group received was not reported.
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Not reported
Duration of treatment / exposure:
Acute = single administration.
Subacute = once/day for 5 days.
Frequency of treatment:
Acute = single administration.
Subacute = once/day for 5 days.
Post exposure period:
Acute = 8 weeks.
Subacute = 7 weeks.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 30, 2500, or 5000 mg/kg bw
Basis:
actual ingested
- for both acute and subacute studies.
No. of animals per sex per dose:
Acute = 16-20 pregnant females (number of males not reported).
Subacute = 17-20 pregnant females (number of males not reported).
Control animals:
yes
Positive control(s):
triethylenemelamine
- Doses / concentrations: 0.2 mg/kg bw

Examinations

Details of tissue and slide preparation:
Not reported
Evaluation criteria:
Not reported
Statistics:
Chi square test and Armitage test.

Results and discussion

Test results
Sex:
female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

It should be noted that neither vehicle nor positive controls were used in the subacute study.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative