Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Repeated dose toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1989
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source only (rabbit is not the standard species)

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Menthenamine (COLIPA, 1989)
Author:
Zondlo, M.M.
Year:
1992
Bibliographic source:
J. Am. Col. Toxicol. 11, 531-558

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Review article only. No guideline indicated. For details on method see IUCLID5 materials and methods section.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methenamine
EC Number:
202-905-8
EC Name:
Methenamine
Cas Number:
100-97-0
Molecular formula:
C6H12N4
IUPAC Name:
1,3,5,7-tetraazatricyclo[3.3.1.1³,⁷]decane
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
not indicated.

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on exposure:
Two ml of 0.20% methenamine (equivalent to 1.3 mg/kg bw/d assuming a mean body weight of 3 kg) were applied in distilled water to one group of rabbits.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
5 days a week
Doses / concentrations
Remarks:
Doses / Concentrations:
0.20% methenamine (equivalent to 1.3 mg/kg bw/d assuming a mean body weight of 3 kg)
Basis:
nominal per unit area
No. of animals per sex per dose:
6 males
Control animals:
yes, concurrent no treatment
Details on study design:
Two groups of rabbits (strain unspecified), 6 males per group, were used in this repeated dose dermal toxicity test. Two ml of 0.20% methenamine (equivalent to 1.3 mg/kg bw/d assuming a mean body weight of 3 kg) were applied in distilled water to one group of rabbits; the other group served as a control. The methenamine treated animals received applications of test solution during 5 days a week for a period of 6 weeks; the applications were given without occlusive patches.
Positive control:
no positive control

Examinations

Observations and examinations performed and frequency:
General behavior, hair growth, and body weight gain, erythema, edema, scratching, or variation of the cutaneous fold.
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
General behavior, hair growth, and body weight gain were comparable in both the controls and methenamine treated groups applying about 1.3 mg/kg bw/day. No erythema, edema, scratching, or variation of the cutaneous fold were observed in the methenamine treated animals treated with a 0.2 % solution of methenamine when compared to the controls.

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 1.3 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
other: no adverse effects observed.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
General behavior, hair growth, and body weight gain were comparable in both the controls and methenamine treated groups. No erythema, edema, scratching, or variation of the cutaneous fold were observed in the methenamine treated animals treated with a 0.2 % solution of methenamine when compared to the controls.
Executive summary:

Two groups of rabbits (strain unspecified), 6 males per group, were used in this repeated dose dermal toxicity test. Two ml of 0.20% methenamine (equivalent to 1.3 mg/kg bw/d assuming a mean body weight of 3 kg) were applied in distilled water to one group of rabbits; the other group served as a control receiving the vehicle (water) only. The methenamine treated animals received applications of test solution during 5 days a week for a period of 6 weeks; the applications were given without occlusive patches. General behavior, hair growth, and body weight gain were comparable in both the controls and methenamine treated groups. No erythema, edema, scratching, or variation of the cutaneous fold were observed in the methenamine treated animals treated with a 0.2 % solution of methenamine when compared to the controls.