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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic 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: Comparable to guideline study with acceptable restrictions (no data on GLP status, name of organs examined not stated, reduced clinical chemistry)

Data source

Reference
Reference Type:
publication
Title:
Toxicity of disodium sebacate
Author:
Greco A.V., Mingrone G., Mastrimattei A. E., Finotti E., Castagneto M.
Year:
1990
Bibliographic source:
DRUGS EXPTL. CLIN . RES. XVI (10) 531 -536

Materials and methods

Principles of method if other than guideline:
The test animals were continuously fed a diet containing the test substance for 6 months. During the feeding period, animals were checked for signs of toxicity and substance-dependent mortality. Gross pathological findings of the animals too were also monitored and recorded before, during and at the end of the observation period. Body weight were taken every 15 days. All surviving animals were sacrificed on day 181, necropsied and histological examination of the different organs was performed.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Disodium sebacate (DSS)
IUPAC Name:
Disodium sebacate (DSS)
Constituent 2
Reference substance name:
Disodium sebacate
EC Number:
241-300-3
EC Name:
Disodium sebacate
Cas Number:
17265-14-4
IUPAC Name:
disodium sebacate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Average weight at study initiation:
Male: 174.6 ± 6.3 g; 176.8 ± 13.2 g
Female: 142.2 ± 7.13 g; 141.7 ± 7.54 g
Two groups of twenty Wistar rats (ten males and ten females) were fed for 6 months a pellet diet containing IDSS at two different dosages : 500 mg/kg b.w. for the first group and 1000 mg/kg b.w. for the second group.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: pellet diet containing the test substance
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6 months
Frequency of treatment:
continuously
Doses / concentrations
Remarks:
Doses / Concentrations:
500; 1000 mg/kg bw
Basis:
nominal in diet
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
The growth curve of rats was drawn based on the body weight at 15-day intervals.

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: every 15 days

ORGAN: yes
- Time schedule for examination: at death or after sacrifice.
- Organs examined: no data

CLINICAL CHEMISTRY and HAEMATOLOGY: Yes
- Parameters checked: plasma, glucose, BUN, serum creatinin, SGOT, SGPT, Hb.
Sacrifice and pathology:
Surving animals were sacrificed 181 days after begin of feeding and macro- and microscopic examinations of the organ were performed.
Statistics:
The DSS concentration used and percentage of mortality were respectively plotted on abscissa and ordinate of a logarithmic paper according to Miller and Tainter The best fitting straight line of the plotted points allows calculation of the LD50 which is the dosage value at 50% of mortalit . The standard error (s.e.) was estimated by this formula : (doses 84% - 16%) x square root of 2N, where N is the number of animals contributing to the values plotted.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Details on results:
MORTALITY:
No death were observed during the chronic toxicity study.

CLINICAL SIGNS:
The general conditions of the animals determined by physical examination and general observation did not show qualitative toxic signs.

FOOD AND WATER CONSUMPTION:
Food and water consumption were normal, as confirmed by the analysis of body weight gains which were not different from those values obtained from the controls.

HISTOPATHOLOGY:
No histological alterations were observed in any of the tissues and organs examined

CLINICAL CHEMISTRY:
Biological parameters (plasma glucose, BUN, serum creatinine, SGOT, SGPT and Hb) were similar to those of the controls

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (nominal)
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
After oral administration of disodium sebacate on rats for a 6 months period, no mortality and clinical signs were observed. Based on a read across (category approach), undecanedioic acid is not expected to show subchronic oral toxicity.