Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
Written assessment
Type of information:
other: Written assessment
Adequacy of study:
other information
Study period:
January 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Written assessment
Justification for type of information:
At the current level of registration, a written assessment is suitable.

Data source

Reference
Reference Type:
other: Written assessment
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Objective of study:
other: Written assessment of ADME
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Written assessment based on available study data.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
EC Number:
201-044-5
EC Name:
2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
Cas Number:
77-62-3
Molecular formula:
C29H40O2
IUPAC Name:
2-{[2-hydroxy-5-methyl-3-(1-methylcyclohexyl)phenyl]methyl}-4-methyl-6-(1-methylcyclohexyl)phenol
Test material form:
solid: particulate/powder
Details on test material:
Name: 2,2’-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
CAS Number: 77-62-3
Batch/Lot number: WWP4J0001
Appearance: White to cream powder
Purity: Considered as 100% (>95%)
Manufacture date: 04 September 2014
Expiry date: 03 September 2018
Storage conditions: Controlled room temperature (15-25 °C, below 70 RH%)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
See attached background material below.
Details on distribution in tissues:
See attached background material below.
Details on excretion:
See attached background material below.

Metabolite characterisation studies

Details on metabolites:
See attached background material below.

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
See attached background material below.

Applicant's summary and conclusion

Conclusions:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
Executive summary:

In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.