Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Weight of evidence
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Weight of evidence
Title:
Toxicokinetics
Author:
Sustainability Support Services (Europe) AB
Year:
2013
Bibliographic source:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: estimation
Vehicle:
unchanged (no vehicle)

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Considering the use of 5-nitrosalicylic acid, as a dye and medicinal intermediate; the most likely route of exposure is expected to be dermal. However, considering that in an industrial environment the use of gloves is prevalent, dermal absorption shall be limited.


Details on distribution in tissues:
5-nitrosalicylic acid is soluble in water as well as methanol. Thus, it is highly likely that this substance, if absorbed is likely to be distributed to the other parts of the living system through the blood and lipids. But given its low bio-concentration factor (BCF) of 3.2, 5-nitrosalicylic acid shall not bio-accumulate in the living system and is likely to be excreted out of the body.


Details on excretion:
5-nitrosalicylic acid is soluble in water as well as methanol. Thus, it is highly likely that this substance, if absorbed is likely to be distributed to the other parts of the living system through the blood and lipids. But given its low bio-concentration factor (BCF) of 3.2, 3-oxoglutaric acid shall not bio-accumulate in the living system. As a general rule, the chemicals that do not bio-accumulate are likely to be excreted out of the body either through urine, bile or faeces.

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: no or low bio-accumulation potential based on the properties
Based upon the physico-chemical properties and bio-concentration factor of 5-nitrosalicylic acid, it has been deduced that the chemical has potentially no or low bio-accumulative property and shall be eliminated from the body system through urine, bile or feaces posing no danger to the living organism.

Executive summary:

Based upon the physico-chemical properties and bio-concentration factor of 5-nitrosalicylic acid, it has been deduced that the chemical has potentially no or low bio-accumulative property and shall be eliminated from the body system through urine, bile or feaces posing no danger to the living organism.