[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Standard guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C.I. Solvent Brown 53

IUPAC Name:

C.I. Solvent Brown 53

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 2.0-2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

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:

other: sesame oil

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50 % suspension

VEHICLE
- Amount(s) applied (volume or weight with unit): 500µL

Duration of treatment / exposure:

4 hours

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cellulose patch on a piece of surgical plaster

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

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4-72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

a transient, very slight erythema was recorded at the end of exposure only

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study test item is not irritating to skin.

Executive summary:

PROCEDURE

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g of the test item pasted with 0.5 ml sesame oil DAB 10.

The substance was administered over the whole surface of a 2.5 x 2.5 em 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.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE

All other changes of the skin were recorded.

RESULTS

30 - 60 minutes after decontamination two animals showed very slight erythema. 24 hours after decontamination all signs of irritation disappeared.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar all animals: 0.0

Oedema formation all animals: 0.0

Conclusion

Based on the results of this study the test item is not irritating to skin.