Registration Dossier
Registration Dossier
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EC number: 202-905-8 | CAS number: 100-97-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-05-16 to 1984-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 5 months
- Weight at study initiation: 2.0 - 2.7 kg
- Housing: single housing (stainless steal cages, model Asta)
- Diet: Standard diet ssniff
- 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
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated right flank of the animals
- Amount / concentration applied:
- 0.5 g moistened with 0.12 ml water
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- not indicated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no responses detected
- Other effects:
- no other effects observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Methenamine is not irritating to the rabbit skin.
- Executive summary:
In a primary dermal irritation study, 5 months old White Russian rabbits (male and female) were dermally exposed to 0.5 g of methenamine moistened with
0.12 ml water for 4 hours to the rabbits neck. Animals then were observed for 72 h. Irritation was scored by the method of Draize.
No erythema and edema was observed during the observation period (Scores 0).
In this study, methenamine is not a dermal irritant.
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