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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
EC Number:
230-989-6
EC Name:
p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
Cas Number:
7394-38-9
Molecular formula:
C7 H5 N O4 . C6 H15 N O3
IUPAC Name:
p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
solid - liquid: aqueous solution

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Sprague-Dawley Crl:CD® (SD) IGS BR rat
Sex:
male/female

Administration / exposure

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.

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.