Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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:

Savinyl Red 3BLS

IUPAC Name:

Savinyl Red 3BLS

Constituent 2

Reference substance name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)

IUPAC Name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)

Constituent 3

Reference substance name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)

EC Number:

275-959-3

EC Name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)

Cas Number:

71735-61-0

Molecular formula:

C40H38CoN6O10S2.Na

IUPAC Name:

Cobaltate(1-), bis[4-(hydroxy-kO)-3-[2-[2-(hydroxy-kO)-1-naphthalenyl]diazenyl-kN1]-N-(3-methoxypropyl)benzenesulfonamidato(2-)]-, sodium (1:1)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Information as provided by the Sponsor. A Certificate of Analysis supplied by the Sponsor is given in Annex 1 (see attachment 1)
Identification: Savinyl Red 3BLS
Other name: Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-me¬thoxypropyl)benzenesulphonamidato(2 )]cobaltate (1-)
C.I. Index: Solvent Red 91 (S. R. 91)
CAS number: 71735-61-0
Batch: AAM0021341
Physical state/Appearance: very dark red powder
Purity: 93.2% (w/w)
Expiry Date: 13 October 2021
Storage Conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animal Information
Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Limited, Leicestershire, UK. At the start of the study the animals weighed 2.65 or 3.13 kg and were 12 to 52 weeks old. After an acclimatization period of at least 5 days each animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.
Animal Care and Husbandry
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: test material was moistened with 0.5 ml of distilled water.

Controls:

no

Amount / concentration applied:

0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

2

Details on study design:

On the day before the test each of a group of two rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal: 75365 Male

Time point:

other: Mean at 24, 48 and 72 hours

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal: 75371 male

Time point:

other: mean at 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

other: Oedema Formation

Basis:

animal: 75365 male

Time point:

other: mean of 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

other: Oedema Formation

Basis:

animal: 75371 male

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The individual scores for erythema/eschar and edema are given in Appendix 1.
Very slight erythema and very slight edema were noted at both treated skin sites immediately after patch removal. Well defined erythema and very slight or slight edema were noted at both treated skin sites 1 hour after patch removal and at the 24 Hour observation. Well defined erythema and very slight edema were noted at one treated skin site and very slight erythema and very slight edema were noted at the other treated skin site at the 48 Hour observation. Very slight erythema, with or without very slight edema, were noted at both treated skin sites at the 72 Hour observation.
Light brown discoloration of the epidermis was noted at both treated skin sites 1 and 24 hours after patch removal.
Both treated skin sites appeared normal at the 7 Day observation.

Other effects:

Body Weight
Individual body weights and body weight change are given in Appendix 2.
Both animals showed expected gain in body weight during the study

Any other information on results incl. tables

Appendix1     Skin Irritation Scores

Individual Scores for Skin Irritation

Rabbit Number and Sex	Observation Time (following patch removal)	Erythema/Eschar Formation	Edema Formation
75365Male	Immediate	1	1
75371Male		1	1
75365Male	1 Hour	2Br	2
75371Male		2Br	1
75365Male	24 Hour	2Br	2
75371Male		2Br	1
75365Male	48 Hour	2	1
75371Male		1	1
75365Male	72 Hour	1	1
75371Male		1	0
75365Male	7 Days	0	0
75371Male		0	0

Br=  Light brown discoloration of the epidermis

Appendix 1 (continued)       Skin Irritation Scores

Mean Values after 24, 48 and 72 Hours

Rabbit Number and Sex	Number of available data points	Erythema/Eschar Formation	Edema Formation
75365Male	3	1.7	1.3
75371Male	3	1.3	0.7

Assessment According to Regulation (EC) No. 1272/2008

Evaluated Intervals	Erythema/Eschar Formation	Edema Formation
24 Hours	Not classified	Not classified
48 Hours
72 Hours

 

Appendix 2     Individual Body Weights and Body Weight Change

Rabbit Number and Sex	Individual Body Weight (kg)		Body Weight Change (kg)
	Day 0	Day 7
75365Male	3.13	3.33	0.20
75371Male	2.65	2.87	0.22

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008.

Executive summary:

The skin irritation potential of the test item was investigated according to a method compatible with OECD test guideline No. 404 and Method B4. 0.5 g of the test item was applied to the intact skin of two young adult New Zealand White rabbits. Scoring of skin irritation effects was performed approximately 1, 24, 48 and 72 hours and 7 days after test item application. 

The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after application) for erythema and edema. The individual mean scores for erythema were 1.3 or 1.7 and 0.7 or 1.3 for edema. 

The application of the test item onto

the skin resulted in well-defined erythema, very slight or slight edema and light brown discoloration of the epidermis. These effects were reversible and were no longer evident 7 days after treatment in both animals (end of the observation period). No corrosion was observed at any of the measuring intervals. No clinical signs of toxicity were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit skin.

According to the findings in this study, the test item

does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008.