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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2012-06-12 to 2012-06-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability is rated 1 because the study followed the standard guideline of reference OECD 404, which describes a procedure designed to evaluate this endpoint. The results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
EC Number:
700-761-5
Molecular formula:
not applicable
IUPAC Name:
tetrakis{9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium} C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate]
Details on test material:
- Name of test material (as cited in study report): Sepisol Fast Red SN
- Substance type: Organic Salt - UVCB
- Physical state: Red Powder
- Analytical purity: > 99%
- Lot/batch No.: 029244
- Expiration date of the lot/batch: 2020-10-19
- Stability under test conditions: Stable
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks old
- Weight at study initiation: between 2.20 kg and 2.46 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): Ad libitum - Tap-water from public distribution
- Water (e.g. ad libitum): Ad libitum - Foodstuff (SDS-C15)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test item as supplied, moistened beforehand with distilled water


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
Exposure of 4 hours
Observation period:
Observation at 1, 24, 48 and 72 hrs after removal of the patch
Number of animals:
1 rabbit + 2 other rabbits.
Details on study design:
TEST SITE
- Area of exposure: 6 cm² per patch. an untreated area on the opposite flank served as control.
- Type of wrap if used: a strip of surfical adhesive tape under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water and liquid paraffin
- Time after start of exposure: at the end of the exposure period, i.e after 4h.

SCORING SYSTEM: Grading of Skin Reactions as displayed in the OECD No. 404, dated April 24th, 2002.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Other effects:
A pink coloration, not preventing local observations, was noted between days 0 and 3 in all animals.

Any other information on results incl. tables

Individual skin reactions and average scores after 4 -hour exposure

OBSERVATIONS

INDIVIDUAL DATA

Total of individual data

Skin reaction

Observation time

Animal n°

Weight (kg)

Animal n°

Weight (kg)

Animal n°

Weight (kg)

A2132

(application date : 2012-06-12)

Start: 2.33

A2174

(application date : 2012-06-19)

Start: 2.34

A2177

(application date : 2012-06-19)

Start: 2.20

End: 2.46

End: 2.42

End: 2.32


Erythema and eschar

1 hour (D0)

0

0

0

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours*

0

0

0

0

Mean(24 to 72 hrs)

0.0

0.0

0.0

/

Oedema formation

1 hour (D0)

0

0

0

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours*

0

0

0

0

Mean(24 to 72 hrs)

0.0

0.0

0.0

/

Other reactions

1 hour (D0)

0

24 hours

0

48 hours

0

72 hours*

0

Mean(24 to 72 hrs)

0.0

0.0

0.0

/

* As no persistent reaction was observed 72 hours after the treatment, the study was ended.

²: pink coloration, not preventing local observations.

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, in these experimental conditions, enable to conclude that the test item SEPISOL FAST RED SN must not be classified, according to the criteria for classification, packging and labelling of dangerous substances and preparations in compliance with the E.E.C. directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.

In accordance with the regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item SEPISOL FAST RED SN was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established from the OECD guideline No. 404 dated April 24th, 2002 and the test method B.4 of the Council regulation No. 440/2008 of 30 May 2008.

No cutaneaous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours). A pink coloration, not preventing erythema assessment, was noted between days 0 and 3 in all animals.

The results obtained, in these experimental conditions, enable to conclude that the test item SEPISOL FAST RED SN must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.

In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.