3-hydroxy-3'-nitro-2-naphthanilide

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-3'-nitro-2-naphthanilide

EC Number:

205-209-2

EC Name:

3-hydroxy-3'-nitro-2-naphthanilide

Cas Number:

135-65-9

Molecular formula:

C17H12N2O4

IUPAC Name:

3-hydroxy-N-(3-nitrophenyl)-2-naphthamide

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff;® K-H (V2333), ad libitum, and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

0.5 g mixed with 0.35 mL physiological saline

Duration of treatment / exposure:

exposure period was 4 hours
after the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water

Observation period:

72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

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

SCORING SYSTEM: according to the score of DRAIZE
- Method of calculation: mean of 24/48/72 h for each rabbit

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 day

Remarks:

(at 30-60 min: score 1)

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 day

Remarks:

(at 30-60 min: score 1)

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1 day

Remarks:

(at 30-60 min: score 1)

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility inapplicable due to missing effects

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility inapplicable due to missing effects

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility inapplicable due to missing effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

The test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008.

Conclusions:

Mean scores (mean of the 24, 48, 72 h readings) of animal # 1 / 2 / 3:

Erythema: 0.0 / 0.0 / 0.0
Edema: 0.0 / 0.0 / 0.0

not irritant, not corrosive

Executive summary:

The substance was tested for primary dermal irritation in the rabbit according to OECD guideline 404. The hair in the dorsal region of three New Zealand albino rabbits was removed with an electric clipper. Each animal was treated with 0.5 g of the test item pasted with 0.35 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

One hour after removal of the patches the treated skin of the animals showed a very slight erythema. One day after removal of the patches all irritations were reversible.

Based on these results it can be stated the test item is not irritant to skin.

Therefore, the test item has not to be classified for skin irritation/corrosion according to Regulation (EC) No 1272/2008