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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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Reliability of original study is 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no guideline available
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Duration of treatment / exposure:
5-weeks
Doses / concentrationsopen allclose all
Dose / conc.:
100 ppm
Remarks:
nominal in water
Dose / conc.:
500 ppm
Remarks:
nominal in water
Dose / conc.:
2 500 ppm
Remarks:
nominal in water
No. of animals per sex per dose:
10 male and 10 female rats
Control animals:
yes

Results and discussion

Results of examinations

Description (incidence and severity):
Growth was reduced only in male rats administered 2500 ppm.
Description (incidence):
mortality was not affected by treatment.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
Food was not affected by treatment
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
water intake was not affected by treatment
Haematological findings:
no effects observed
Description (incidence and severity):
Up to 2500 ppm, no damage to blood or organs have been observed.
No kidney effects have been observed in blood and urine analysis, and histopathological studies.
Urinalysis findings:
no effects observed
Description (incidence and severity):
No kidney effects have been observed in blood and urine analysis, and histopathological studies.
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
General behaviour was not affected by treatment
Gross pathological findings:
effects observed, non-treatment-related
Description (incidence and severity):
Pathology and anatomy analysis revealed no other damage to other organs related to the test item.
Description (incidence and severity):
No liver effects have been observed in clinic, anatomy, pathology and histopathology studies up to 2500 ppm.
No kidney effects have been observed in blood and urine analysis, and histopathological studies.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
500 ppm
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
Dose descriptor:
NOAEL
Effect level:
2 500 ppm
Based on:
test mat.
Sex:
female
Basis for effect level:
clinical signs
body weight and weight gain
food consumption and compound intake
water consumption and compound intake
haematology
clinical biochemistry
behaviour (functional findings)
organ weights and organ / body weight ratios
gross pathology
histopathology: non-neoplastic

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Concentrations of 100 and 500 ppm were therefore well tolerated by males, while concentrations up to 2500 ppm were tolerated without negative effects by female rats.
Executive summary:

The toxic potential of the substance after a repeated exposure via the oral route was evaluated. Ten male and ten female Wistar rats were exposed to four dose levels (0 -100 -500 -2500 ppm) for 5 weeks.

Food and water intake, general behaviour and mortality were not affected by treatment. Growth was reduced only in male rats administered 2500 ppm.

Up to 2500 ppm, no damage to blood or organs have been observed.

No liver effects have been observed in clinic, anatomy, pathology and histopathology studies up to 2500 ppm.

No kidney effects have been observed in blood and urine analysis, and histopathological studies.

Glucose and cholesterol concentrations in plasma and sodium, potassium, calcium, inorganic phosphate and chlorine products in serum were in the normal range in all dose groups.

Pathology and anatomy analysis revealed no other damage to other organs related to the test item.

NOAEL (male) = 500 ppm

NOAEL (female) = 2500 ppm