Strontium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)azo]-2- naphthoate 5/2 hydrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 December 2007- 21 December 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

484-490-5

EC Name:

-

Molecular formula:

Hill formula:C21 H12 N2 O6 S Sr 5/2(H2O) CAS formula: C21 H14 N2 O6 S . Sr

IUPAC Name:

strontium(2+) 3-hydroxy-4-[(1E)-2-(1-sulfonatonaphthalen-2-yl)diazen-1-yl]naphthalene-2-carboxylate

Test material form:

solid: granular

Details on test material:

Red Powder.
Batch-070711
Purity>=96.4 %
Storage-Room temperature in the dark.
Stable under storage conditions.
Epiry date-11 July 2011

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Horst, The Netherlands.
- Age at study initiation: 6 weeks old
- Weight at study initiation: at least 1.0 kg.
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany) approximately 100 grams per day. Hay (Tecnilab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum):Free access to tap water.
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0 °C (actual range: 20.7 - 21.7 °C), a relative humidity of 30-70 % (actual range: 26 - 59 %) and 12 hours artificial fluorescent light and 12 hours darkness per day.


IN-LIFE DATES: From:07 December 2007 To:-21 December 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Since the test substance did not mix with water, the powdery test substance was moistened with watery ethanol (50% v/v) (water, Elix, Millipore SAS., Molsheim, France; ethanol, Merck, Darmstadt, Germany)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Each animal was treated by dermal application of 0.5 grams of the test substance.
- Concentration (if solution):The test substance was moistened with 1 ml of the vehicle.

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

Number of animals:

3 animals

Details on study design:

TEST SITE
the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 x 15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations. Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 1 mL of the vehicle and applied to the skin of one flank, using a metalline patch of 2 x 3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water, watery ethanol (50 % v/v) (water, Elix, Millipore SAS., Molsheim, France; ethanol, Merck, Darmstadt, Germany) and watery acetone (50 % v/v) (water, Elix, Millipore SAS., Molsheim, France; acetone, VWR Prolabo, Leuven, Belgium). On Day 3, the skin of one animal was cleaned of residual test substance using watery ethanol and watery acetone.

OBSERVATION TIME POINTS
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

SCORING SYSTEM:
- Method of calculation: Scoring system for Erythema and eschar formation and Oedema formation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Mean value based on three animals.

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

Mean value based on three animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since no oedema was observed throughout the observation period and no erythema was observed after 72 hours, it was considered that no severe erythema was present during the first 48 hours after exposure. Therefore, the results were considered sufficient for classification and labelling purposes.

Based on these results, R507-2 does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).

Executive summary:

Primary skin irritation/corrosion study with R507-2 in the rabbit (4-hour semi-occlusive application).

 Three rabbits were exposed to 0.5 grams of R507 -2, moistened with 50 % watery ethanol by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

 

 

No oedema in the treated skin of the rabbits was caused by 4 hours exposure to 0.5 g of

R507-2. No erythema was noted at 72 hours after exposure.Red staining of the treated skin by the test substance prevented scoring for erythema at 1, 24 and 48 hours after exposure.

 

Following exposure and throughout the observation period, red staining of the treated skin by the test substance was observed.

 

 

Since no oedema was observed throughout the observation period and no erythema was observed after 72 hours, it was considered that no severe erythema was present during the first 48 hours after exposure. Therefore,the results were considered sufficient for classification and labeling purposes.

 

Based on these results, R507-2 does not have to be classified and has no obligatory labeling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC.