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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: old public available literature, non GLP, non Guideline

Data source

Reference
Reference Type:
publication
Title:
Carcinogenicity and toxicity tests of Hexamethylenetetramine in mice and rats
Author:
Della Porta, G.
Year:
1966
Bibliographic source:
Food Cosment. Toxicol. 3, 362-363

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The study was conducted in 1966 before OECD Guidelines existed. Public available literature. No guideline indicated but similar to OECD limit test, but with two doses. For details on method see IUCLID5 materials and methods section.
GLP compliance:
no
Test type:
other: no data
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:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
adult rats were used.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
An 80% aqueous solution was administered by oral intubation.
Doses:
10 g/kg and 20 g/kg
No. of animals per sex per dose:
five animals per group (sex not indicated)
Control animals:
not specified
Details on study design:
Two groups of five rats were given 10 g/kg and 20 g/kg of methenamine as an 80% aqueous solution by oral intubation.
Statistics:
not indicated.

Results and discussion

Preliminary study:
no data on preliminary study
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Sex:
not specified
Dose descriptor:
other: NOAEL
Effect level:
>= 20 000 mg/kg bw
Mortality:
no mortality observed.
Clinical signs:
other: not indicated
Gross pathology:
not indicated
Other findings:
not indicated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of methenamine is > 20000 mg/kg bw after single oral administration to rats.
Executive summary:

In an acute oral toxicity study, 2 groups of adult Wistar rats (5 animals per dose) were given a single oral dose of methenamine (80 %) in water at doses of 10000 and 20000mg/kg bw.

Oral LD50 > 20000 mg/kg bw

All animals survived.

Hexamethylenetetramine is of practically no toxicity based on the LD50 in rats.