5-nitroisophthalic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Assesment of a possible irritating or corrosive potential of the skin

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-nitroisophthalic acid

EC Number:

210-568-3

EC Name:

5-nitroisophthalic acid

Cas Number:

618-88-2

Molecular formula:

C8H5NO6

IUPAC Name:

5-nitroisophthalic acid

Test material form:

solid

Details on test material:

IUPAC name: 5-Nitrobenzene-1,3-dicarboxylic acid
Mol. formula: C8H5NO6
Molecular Weight: 211.128 gm/mol
Smiles: OC(=O)c1cc(cc(c1)[N+](=O)[O-])C(=O)O
InChI: InChI=1S/C8H5NO6/c10-7(11)4-1-5(8(12)13)3-6(2-4)9(14)15/h1-3H,(H,10,11)(H,12,13)

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Male: 2.79 gm
Female: 2.85 gm
- Housing: Cage made of stainless steel with wire mesh walk floors. (Floor area: 40cm x 51cm)
- Diet (e.g. ad libitum):
- Water : 250 ml tap water/animal/day
- Acclimation period: Atleast 8 days before the study. Same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): Fully air conditioned
- Photoperiod (hrs dark / hrs light): 12h/12h (6.00-18.00 hours/18.00-6.00 hours)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50% aqueous formulation (W/W)
THE TEST PATCH (2.5 CM X 2.5 CM) IS COVEREO WITH AN ABOUT 0.5 MM LAYER OF THE 50% SUSPENSION (THUS ABOUT 0.5 G OF THE SUSPENSION IS APPLIED; BECAUSE OF THE NATURAL MOISTURE OF TNE SKIN, DISTILLED WATER IS USED TO PREPARE THE SUSPENSIONS SO THAT THE TEST CAN BE CARRIED OUT UNDER AS PHYSIOLOGICAL CONDITIONS AS POSSIBLE.

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes after the removal of the test patch.
24, 48 and 72 hours after the beginning of the application

Number of animals:

Total: 3
Male: 1
Female: 2

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back or flanks
- % coverage: (2.5cm x 2.5 cm)
- Type of wrap if used: Porous dressing (Four layers of absorbent gauze+porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 72 hrs

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 30-60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application.

SCORING SYSTEM:
- Method of calculation:

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation potential observed

Other effects:

No other effects observed.

Any other information on results incl. tables

Table: Body weight data

Animal	1	2	3
Animal no.	0075	0100	0085
Body weight (kg)	2.79	2.72	2.97
Sex	Male	Female	Female

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

No clinical signs of Erythema and Edema were observed during the observation period, thus indicating that the test chemical is not irritating to skin of rabbits.

Executive summary:

Acute skin irritation test, according to OECD guidelines 404 for testing of chemicals, was conducted on the intact dorsal skin of the Vienna white rabbit for test substance. 50% aqueous solution of the test substance was applied in an area of 2.5 cm x 2.5cm on the upper third of the back of the test animals. The test animals were exposed for 4 hours and readings were taken 30 -60 minutes after the removal of test patches and 24 H, 48 H. 72 H, after the beginning of application. Untreated skin sites of the same animal were treated as negative control. Observations were made for appearance of any symptoms of Erythema and Edema on the tested skin sites. However, none of the observations taken at different intervals showed any clinical signs of Erythema and Edema. Based on the results, the test substance was considered as not irritating to skin.