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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: adduct formation
Type of information:
other: publication
Adequacy of study:
supporting study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The data concern a literature study; GLP conditions or Guidelines for testing are not mentioned.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991
Report date:
1990

Materials and methods

GLP compliance:
not specified
Type of assay:
other: adduct formation

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
28 days
Frequency of treatment:
once daily

Results and discussion

Additional information on results:
As many as 28 consecutive daily doses of [14C]MOCA at 28.1 µgmol/kg body wt (5 µgCi/day) were administered and rats were euthanized at weekly intervals for 7 weeks. MOCA adduct formation for globin and serum albumin was evaluated by determination of [14C]MOCA covalent binding. The covalent binding associated with globin showed a linear increase over the 28-day exposure period with 342 fmol/mg globin 24 hr after the final dose. More extensive covalent binding was detected for albumin with 443 fmol/mg albumin after the final dose, but increases were not linear. After cessation of dosing, the albumin adduct levels decreased rapidly (t1/2 = 4.6 days) in relation to globin adduct levels (tl/2 = 16.1 days). The MOCA-gIobin adduct tl/2 is consistent with that determined after a single 281 µgmol/kg oral dose of MOCA. Significant differences related to route of administration were detected for 24-hr globin covalent binding with ip > po > dermal. Distribution of undifferentiated [14C]MOCA was highest in the liver at 24 hr with tissue levels for liver> kidney> lung> spleen> testes> urinary bladder. Induction of cytochrome P450 enzymes by administration of phenobarbital (100 mg/kg/day/3 days) resulted in a significant (P < 0.05) increase in MOCA-gIobin adduct formation detected with 33.5 pmol/mg globin for induced rats versus 13.6 pmol/mg globin for control rats.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
Upon administration of 14C MOCA to male rats for 28 consecutive days, adduct formation with globin and albumin was observed.