Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-06-05 to 1984-09-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline Study, non GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

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[3.3.1.1~3,7~]decane
Details on test material:
- Name of test material (as cited in study report): Hexamethylentetramin
- Physical state: White solid
- Lot/batch No.: Lot from 1984-01-20

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 6-7 months
- Weight at study initiation: 2.05 to 2.3 kg
- Housing: single housing (stainless steal cage, model Asta)
- Diet: Standard diet, ssniff (Soest, Gemany)
- Water: ad libitum
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Humidity (%): 50-60 %
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as negative control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
only very weak secretion observed after 1 h.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Methenamine is not irritation to the rabbit eye.
Executive summary:

In a primary eye irritation 0.1 g methenamine was instilled into the conjunctival sac of the eye of 6-7 months old White Russian rabbits (male and female). Animals then were observed for 72 hrs. Effects were scored according to the method of Draize.

No irritation was observed during the observation period (cornea, iris, conjunctiva and chemosis scores 0). Only a very weak secretion was observed after 1 h.

In this study, methenamine is not an eye irritant.