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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V to Directive 67/548/EEC as amended by Annex IVD to Council Directive 96/54/EC,J MHLW, METI, ME (21 November 2003), YAKUSHOKUHATSU No. 1121002, SEIKYOKU No. 2, KANPOKIHATSU No. 031121002,Organisation for Economic Co-operation and Development, Testi
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Details on analytical verification of doses or concentrations:
Group 1-Control-Dose 0mg/kg/day
Group 2-M3MC-Carboxylate-3mg/ml
Group 3-M3MC-Carboxylate-30mg/ml
Group 4-M3MC-Carboxylate-200mg/ml

Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Administration of M3MC-Carboxylate by oral gavage to rats for 4 weeks at a dose level of 1000 mg/kg/day resulted in a number of clinical signs, reduced bodyweight gain, increased water consumption and treatment related findings on the liver and stomach and these findings
taken in combination were considered to be adverse and 1000 mg/kg/day could not be classed as the No Observed Adverse Effect Level (NOAEL).
Among animals treated at 150 mg/kg/day, there was some indication of treatment related disturbance in urinary pH and forelimb grip strength, however, these changes were minor and considered of no toxicological importance. Thus, it is concluded that a dose level of 150 mg/kg/day is classed as the NOAEL.
Executive summary:

Administration of M3MC-Carboxylate by oral gavage to rats for 4 weeks at a dose level of 1000 mg/kg/day resulted in a number of clinical signs, reduced bodyweight gain, increased water consumption and treatment related findings on the liver and stomach and these findings taken in combination were considered to be adverse and 1000 mg/kg/day could not be classed as the No Observed Adverse Effect Level (NOAEL). Among animals treated at 150 mg/kg/day, there was some indication of treatment related disturbance in urinary pH and forelimb grip strength, however, these changes were minor and considered of no toxicological importance. Thus, it is concluded that a dose level of 150 mg/kg/day is classed as the NOAEL.