Registration Dossier

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:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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%
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 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:
No treatment-related sign of toxicity. Local signs comprised test substance staining and isolated cases of transient bandage reaction
Body weight:
No effects
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.