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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP report reported in the LAB risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Composition of test material, percentage of components: <1% C9, 16% C10, 43% C11, 40% C12, 1% C13, <1% C14; avg C11.26

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on oral exposure:
Test material was given daily in the diet for 4 weeks.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2500, 5000, 7500, 20000 ppm (0, 125, 250, 375, 1000 mg/kg bw/day)
Basis:
nominal in diet
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
body weight and food consumption
Sacrifice and pathology:
Histopathology was not done.

Results and discussion

Results of examinations

Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
Reduction in body weight and food consumption were observed at all exposure levels. No gross pathological changes were noted. Histopathology was not carried out. The lowest dose tested was 2500 ppm, which corresponds to 125 mg/kg bw.

Effect levels

Dose descriptor:
LOAEL
Effect level:
2 500 ppm
Basis for effect level:
other: Reduction in body weight and food consumption.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOAEL was less than the lowest dose tested (2500 ppm, equivalent to 125 mg/kg bw/day).
Executive summary:

This study examined the effects of dietary exposure of rats to the test substance. Groups of rats were given diets containing 0, 2500, 5000, 7500, or 20000 ppm test substance for 28 days. Animals were observed for food consumption and body weight changes. At the end of the study, the animals were sacrificed and examined for gross pathology. Reduced food consumption and body weight gain was noted at all dose levels. The NOAEL was < 2500 ppm in the diet. The LOAEL was 2500 ppm in the diet. No abnormalities were seen in the gross pathology examinations.