Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: toxicokinetic information derived from other studies
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Overview based on existing toxicity data.

Data source

Reference
Reference Type:
other: Compilation of available data.
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Principles of method if other than guideline:
Overview based on existing toxicity data.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Succinic acid
EC Number:
203-740-4
EC Name:
Succinic acid
Cas Number:
110-15-6
Molecular formula:
C4H6O4
IUPAC Name:
butanedioic acid

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

The toxicokinetic behaviour of succinic acid was estimated from available data for the purpose of registration of the substance.

Absorption, distribution: No systemic effects were observed in the acute oral toxicity studies even at high doses. Only unspecific systemic effects (reduced body weight, emaciation) were detected in the repeated dose studies at high doses. Therefore it is concluded that an absorption after peroral administration of the submitted substance takes place, at least at high doses. No information on the distribution was obtained, as only unspecific effects were noted.

The logPow is very low (-0.59) and together with the acidic groups of the molecule does not favour an oral or an inhalation absorption of the substance, whereas the low molecular mass of 118 would point to a better absorption. An inhalation absorption is probably of low relevance because of the low vapour pressure of 0.000025331 Pa.

Metabolism:

Succinic acid is an element of the citric acid cycle and is metabolised to fumaric acid.

No relevant differences occurred in the mutagenicity studies with and without the addition of a metabolising system. Therefore no indication of the importance of the metabolism of the test substance was obtained from these studies.

 

Bioaccumulation: A potential for bioaccumulation is unlikely, based on the low partition coefficient. No statement on the bioaccumulation can be derived from the comparison of the effective doses in the acute and the repeated dose oral toxicity study, when also considering the different extent of the investigations in both studies.

Excretion: No relevant data are available, which provide evidence on the route of excretion.