Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test material

Constituent 1
Reference substance name:
oleic-acid based IQAC, DMS quaternised
IUPAC Name:
oleic-acid based IQAC, DMS quaternised
Constituent 2
Chemical structure
Reference substance name:
Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates
EC Number:
931-745-8
Cas Number:
1335203-21-8
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates
Constituent 3
Chemical structure
Reference substance name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
EC Number:
937-237-2
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Quotation from NICNAS report (p.26/27)

9.4.3 Repeat Dose Dermal Studies in Rabbits (TSCATS 1988)

In a repeat dose dermal study, rabbits, 5/sex, received topical application of 2 mL per kg bwt per day of Varisoft 475 at dose levels of 3 or 27 mg active compound per kg bwt per day for 13 weeks (91 days). Animals at both doses had slight to moderate erythema, oedema and desquamation. There were no treatment related changes in body weight. No treatment related changes were observed in clinical pathology, bone marrow smears, organ weights, microscopic changes in skin or histopathological changes to internal organs. The reported NOEL for systemic toxicity was 27 mg active compound per kg bwt per day. In other repeat dose studies of 14 day or 91 day duration (no other details provided), no effects other than skin irritation were reported for Varisoft 475 (FSQSC 1988). The NOELs from the studies on Varisoft 475 are tabulated below.

 

Exposure Duration

 

Highest Dose Tested

NOEL (systemic effects)

14 days 7 hours, 5 days/week*

 

600 mg/kg bwt

600 mg/kg bwt/day

91 days 7 hours, 5 days/week**

 

27 mg/kg bwt

27 mg/kg bwt/day

91 days 7 hours, 5 days/week*

 

300 mg/kg bwt

300 mg/kg bwt/day

91 days 7 hours, 5 days/week*

400 mg/kg bwt

400 mg/kg bwt/day

 

*Source: (FSQSC 1988)

** Source: (TSCATS 1988)

Applicant's summary and conclusion