p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study 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 sensitisation)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

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.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

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.

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

Species:

rabbit

Strain:

New Zealand White

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)

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

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.