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Diss Factsheets

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) (CAS no. 7394-38-9), in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight.

The test item is not classified with oral acute toxicity according to the CLP regulation 1272/2008/EC.

The study concerning the acute inhalation toxicity does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

The study concerning the acute dermal toxicity does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitation).

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
Study period:
10 - 29 October 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Data generated according to internationally accepted testing guideline performed according to GLP, but further details on the test item are lacking in the report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
Sprague-Dawley Crl:CD® (SD) IGS BR rat
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.
The test material was administered orally undiluted.
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.
The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No signs of sytemic toxicity
Body weight:
Female: weekly increase of 19 to 32 g
Male: weekly increase from 32 to 68 g
Gross pathology:
No abnormalities detected
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight.
The test item is therefore not classificated with acute oral toxicity according to the CLP regulation 1272/2008/EC.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley Crl:CD® (SD) IGS BR rat (SPL Standard Test Method 512.07). The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method Bl tris Acute Oral Toxicity (Oral - Acute Toxic Class Method).

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.

The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths or signs of systemic toxicity noted during the study.

The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight. The test item is therefore not classificated with acute oral toxicity according to the CLP regulation 1272/2008/EC.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification