reaction product of: C.I. Leuco Sulfur Black 1 with (3-chloro-2-hydroxypropyl)trimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14. Aug. 1995 to 17. Aug. 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

424-510-1

EC Name:

-

Cas Number:

220150-59-4

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

Reaction products of Phenol, 2,4-dinitro-, sulfurized, leuco derivatives and (3-chloro-2-hydroxypropyl)trimethylammonium chloride

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

CRL:KBL(N2W)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Age at study initiation: 16 weeks
- Weight at study initiation: male: 2.6 kg; females: 2.4 to 2.6 kg
- Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing
- Diet: ad libitum; pelleted standard Kliba 341, batch 90/95 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (contaminant analysis included in report)
- Water: ad libitum; community tap water from Itingen (bacteriological, chemical and contaminant analyses results included in report)
- Acclimation period: four days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3
- Humidity: 30 to 70 %
- Air changes: 10 to 15 minutes
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

10 cm x 10 cm area by electric clipper

Vehicle:

water

Remarks:

moistened only

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Males: 1
Females: 2
Total: 3

Details on study design:

TEST SITE
- Area of exposure: dorsal area measuring 10 cm x 10 cm
- % coverage: not specified
- Type of wrap if used: surgical gauze measuring 3 cm x 3 cm

REMOVAL OF TEST SUBSTANCE
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after the removal of the test item

SCORING SYSTEM:
- Colouration, body weight, corrosion and toxic symptom observations
- Irritation scores (both erythema score and oedema score):

ERYTHEMA AND ESCHAR FORMATION (Maximum possible score: 4)
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

OEDEMA FORMATION (Maximum possible score: 4)
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

CORROSION
No irreversible alterations or corrosive effects observed.

IRRITATION
No irritation signs and symptoms observed.

Other effects:

COLOURATION
The test article caused pale black staining of the treated skin until termination of the study. However, in the absence of signs of irritation, this finding was considered to be insignificant.

BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP criteria (EC 1272/2008)

Conclusions:

The test item was not found to be a skin irritant or a skin corrosive.

Executive summary:

Skin irritation potential was evaluated in an experimental study according to the OECD Guideline 404 (1992) and EU method B.4 (1992). 0.5 g of undiluted, solid test item was applied to the shaved, dorsal area of three rabbits for a duration of 4 hours. Observations were recorded at 1, 24, 48 and 72 hours after removal of test substance. Irritation scores (mean 24, 48 and 72 hours) were 0.0 for both erythema and oedema in all test subjects. In the area of application, pale black staining of the treated skin was observed in all test subjects. No corrosive effect was observed. The test substance is not corrosive or irritating to the skin.