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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 or test system 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:
other: In general, all rat behavioral, clinical, and physiological responses after administration appeared normal.
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

Link to relevant study records
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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
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 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:
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:
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
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