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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a detailed method. None GLP.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Twenty-five young adult (≈ 68 days) Sprague-Dawley male rats were used in the 5 g/kg test group. After the treatment, all animals were observed daily for 30 days for aberrant physiological and behavioral responses.
GLP compliance:
not specified
Limit test:
yes
Specific details on test material used for the study:
Batch No.: not specified
Purity: not specified
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: ≈ 68 days
- Weight at study initiation: 290-330 g

No additonal data
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/cc of corn oil
- Justification for choice of vehicle: This vehicle was used to solubilize the mixture in an innocuous medium.

No additional data
Doses:
5 g/kg
No. of animals per sex per dose:
25 male rats per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 30 days
- Frequency of observations and weighing: After treatment , all animals were observed daily for 30 days for aberrant physiological and behavioral responses.

No additional data
Statistics:
None stated
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
In general, all rat behavioral, clinical, and physiological responses after administration appeared normal.
Body weight:
No information provided
Gross pathology:
No information provided
Other findings:
No information provided
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value for NTO to Sprague-Dawley rat was greater than 5 g/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

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Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Lot number: DDP12K0091-0002
Expiry: 31 December 2022
Purity: 100%
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:
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
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

The oral LD50 for NTO in rats is >5000mg/kg and the dermal LD50 for NTO in rats is >2000mg/kg therefore NTO is not classified under CLP