Reaction products of 2-amino-4,6-dinitrophenol, 4-amino-5-hydroxy 2,7-naphthalenedisulfonic acid, 4-nitrobenzenamine and resorcinol, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25th of November to 2nd of December, 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to internationally accepted guideline.

Justification for type of information:

Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01 of Acid Brown 191

IUPAC Name:

Similar substance 01 of Acid Brown 191

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Kleintierrarm Madoerin AG, CH 4414 Fuellinsdorf I Switzerland
Age at start of treatment: males: 14 weeks, females: 15 weeks
Body weight at start of treatment: male 2.6, female 2.4-2..8
Identification: by unique cage number and corresponding ear tags
Acclimatization: four days under test conditions after veterinary examination.
HUSBANDRY
Room No.: 138
Standard Laboratory Conditions.
Air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40—70%, 12 hour, artificial fluorescent light/12 hours dark, music/light period.
AccommodationIndividually in stainless steel cages equipped with an automatic cleaning and drinking system ( Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830Emmendingen / FRG).
Diet
Pelleted standard Kliba 341, Batch 40/88 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
Analysis for contaminants have been performed.
Water
Community tap water from Itingen, ad libitum.
Analysis for contaminants have been performed.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of the test articleThe test article was applied moistened with distilled water. The moistened test article was warmed up to 40° C degrees centigrade and than cooled down again.The vehicle used, was found to be the most qualified to assure an optimum technical application procedure of the test article.

Duration of treatment / exposure:

4 hours

Observation period:

Viability, mortality: daily
Body weight: day 1 of test (application day) and at termination of test on a Mettler PK 16 balance.
The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.

Number of animals:

1 male2 females

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration.On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi—occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system.The observation was terminated 72 hours after application of the test article.All rabbits were killed by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The substance showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

In the area or application, a brown staining of the treated skin by pigment or coloring of the test article was observed. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Any other information on results incl. tables

Data are summarized in tabular form, showing for each individual animal the irritation scores for erythema and edema at 60 minutes, 24, 48 and 72 hours after patch removal, any lesions, a description or the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed. The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the irritant properties of a material, and they are viewed as reference values. The use of a semi-occlusive dressing is a severe test and the results are not directly comparable to human exposure conditions.

Mean values and standard deviations were calculated whenever possible.

Applicant's summary and conclusion

Interpretation of results:

other: not classified as skin irritant according to the CLP Regulation (EC) No. 1272/2008

Conclusions:

Non irritant/corrosive for the skin

Executive summary:

Method

The irritation/corrosion property was tested on the substance according to the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and the EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion), in GLP.

Observations

Under the conditions of this experiment, the substance was found to cause a primacy irritation score of 0.00 when applied to intact rabbit skin.

Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.

In the area of application, a brown staining of the treated skin by pigment or coloring of the test article was observed.

No corrosive effect had occurred on the skin at any measuring interval.

Results

According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value of the scores for each type of lesion, calculated ftc each animal separately, is the mean 24:-72 hours: 0.00 score in one male and two females.