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Registration Dossier
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EC number: 213-254-4 | CAS number: 932-64-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP test performed according to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- EC Number:
- 213-254-4
- EC Name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- Cas Number:
- 932-64-9
- Molecular formula:
- C2H2N4O3
- IUPAC Name:
- 1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material : 3-NITRO-1 ,2,4-TRIAZOL-5-0NE (NTO)
- Substance type: energetic explosive
- Physical state: light green to white crystalline solid with no odor
- Purity ca.99%
Constituent 1
- Specific details on test material used for the study:
- Lot number: DDP12K0091-0002
Expiry: 31 December 2022
Purity: 100%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: well known breeder
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation:
- Fasting period before study: Not fasted
- Housing: individually housed in cages made of polypropylene or polycarbonate with a stainless steel mesh lid with wood based bedding.
- Diet (e.g. ad libitum): Standard laboratory rodent diet (RM1(E) SQC expanded pellet
- Water (e.g. ad libitum): Water was available ad libitum throughout the study
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Photoperiod (hrs dark / hrs light): 12 h light/12 h of dark
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure:5 cm x 5 cm of skin
- % coverage: 10% of the total body surface area
- Type of wrap if used:porous gauze held in place with a non-irritating dressing and further covered by a waterproof dressing, encircled firmly around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.5 mL/kg
- Concentration (if solution): 1340 mg/mL in 0.5% methylcellulose
- Constant concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Day 1 (prior to dosing), Day 8 and Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight macroscopic pathology, dermal responses
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: No treatment-related sign of toxicity. Local signs comprised test substance staining and isolated cases of transient bandage reaction
- Gross pathology:
- No findings
- Other findings:
- No
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value for NTO to Sprague-Dawley rat was greater than 2 g/kg.
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