Registration Dossier
Registration Dossier
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EC number: 202-905-8 | CAS number: 100-97-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-10-22 to 1997-01-21
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/32/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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:
- rat
- Strain:
- other: HsdCpb: WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: males 8 weeks, females 12 weeks
- Weight at study initiation: Males 267-288 g, females 227-256 g
- Housing: single housing, Macrolon cages, type II
- Diet: standard diet ad libitum (ssniff R-Z, complete diet for rats - breeding, ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 47-53 %
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: between shoulder and sacral region
- Type of wrap if used: bandage and patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Concentration: 2000 mg/kg bw - Duration of exposure:
- 24 hrs
- Doses:
- male and female: 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for the first 4 to 6 hours after application and then once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality, behaviour, body weight, gross necroscopy - Statistics:
- LD50 determination
Results and discussion
- Preliminary study:
- no preliminary study
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Mortality:
- no mortality occurred.
- Clinical signs:
- other: The only clinical finding was a yellowish discoloured application site in all male and female rats. The finding started on day 1 after application and was still present at the end of the 14-day observation period.
- Gross pathology:
- At necroscopy no alterations were detected.
- Other findings:
- No other findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of methenamine after dermal application in the rats is > 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study, groups of young adult HsdCpb: WU rats (5/sex) were dermally exposed to methenamine (99.3 %) in water for 24 hours to the shaved shoulder region at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50
Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Combined > 2000 mg/kg bw
No mortality occurred. The only clinical finding was a yellowish discoloured application site in all male and female rats. The finding started on day 1 after application and was still present at the end of the 14-day observation period. At necroscopy no alterations were detected. Methenamine is thus considered as non toxic, when applied to the skin of rats.
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