Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8.1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, May 2008)
GLP compliance:
no
Remarks:
Not relevant for assessment

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Details on the test material used in the studies assessed are presented in the respective endpoint study records.

Results and discussion

Any other information on results incl. tables

TOXICOKINETIC BEHAVIOUR

The substance is a white solid and the molecular weight is 119.08 g/mol. The low vapour pressure value (5.8 x 10-15Pa at 25°C) and predicted negative explosive and oxidising properties shows that the substance is non volatile therefore inhalation is not a significant route of exposure. The substance has a low log octanol/water partition coefficient value (Log10Pow-3.84) and high water solubility 57.0 to 59.1%

w/w).

 

The available acute dermal and repeated dose reproductive screening studies showed limited evidence of absorption, metabolism and excretion

 

The test item is non-mutagenic, non-genotoxic and non-clastogenic. The test item is not a skin sensitizer however it is considered a mild irritant.

 

Absorption

Results of the repeated dose reproductive screening study in rats showed evidence to support the gastric absorption of the test item. Although the test item is lipophobic in nature the high water solubility (57.0 to 59.1%) and small molecular size of the substance could allow absorption through passive diffusion. This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood.

 

Absorption may also take place via the skin due to small molecular size and water solubility. Although the substance is not a skin sensitizer there is evidence of mild dermal irritation. Therefore damage to the skin surface may allow for increased penetration of the substance through the skin.

 

The low vapour pressure value (5.8 x 10-15Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.

 

Distribution

 

Systemic distribution is evident from the repeated dose reproductive screening study as a result of the organ changes observed.

 

Once absorbed, the substance may be distributed in serum due to the water solubility and may therefore be distributed systemically.

Metabolism

 

The results of the repeated dose reproductive screening study did not show evidence of any enhanced metabolism.

The results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising system.

Excretion

 

The results of the repeated dose reproductive screening study would suggest that the most likely route of excretion is the kidney due to the likely systemic distribution and water solubility of the test item. Any test item that is not absorbed will be excreted in the faeces.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: See summary in conclusions sectionThe available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin.Once absorbed, the substance would be distributed in the serum and urine is the significant route of excretion.
Executive summary:

The test item is an inorganic substance. The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physico-chemical properties of the substance. Once

absorbed, the substance would result in distribution in the serum. Urinary excretion is considered to be the significant route for the substance.