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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 - 14 October 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study can be used to draw a conclusion on the non corrosive/ non-irritating properties to skin of the tested substance. The report consists of a summary of the conducted study including detailed raw data without detailed information on the procedure followed.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
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:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml

VEHICLE
- not required

Duration of treatment / exposure:
4 hour
Observation period:
1, 24, 48 and 72 hours after administration
Number of animals:
3
Details on study design:
TEST SITE
the test material was administered to the intact skin

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after administration.

SCORING SYSTEM:
- Method of calculation: prinmary irritation index, according to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
To evaluate the classification of the substances according to CLP Regulation, the raw data were reinterpreted.
The mean value from gradings at 24, 48 and 72 hours after patch removal calculated in at least 2 of 3
tested animals were the following:
- erythema/eschar: score 0/6=0 (3 out of 3 animals)
- oedema: 0/6=0 (3 out of 3 animals)
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results allows clear decision that the substance p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) is not corrosive and not irritating to skin according to the regulation 1272/2008/EC after reinterpretation of the raw data.
Executive summary:

A study was performed to assess the irritation potential of the test material p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal lrritation/Corrosion" and Method 84 of Commission Directive 92l69lEEC (which constitutes Annex V of Council Directive 67l54SlEEC).

The results may be used as a basis for classification and labelling according to the Regulation 1272/2008/EC after reinterpretation of the raw data.

A single 4-hour semi-occluded application (0.5 ml) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

The mean value from gradings at 24, 48 and 72 hours after patch removal calculated were the following:

- erythema/eschar: score 0/6=0 (3 out of 3 animals)

- oedema: 0/6=0 (3 out of 3 animals)

No evidence of skin irritation/corrosion was noted. The test material is not corrosive and not irritant to skin according to the regulation 1272/2008/EC.