[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 26, 2012 to August 21, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to the OECD 404 and EU B4 Method with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000) including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Molecular formula:

not applicable, UVCB

IUPAC Name:

Condensation products of cyclopentanone and pentaldehyde, fractionation pitch

Details on test material:

- Name of test material (as cited in study report): Condensation products of cyclopentanone and pentaldehyde, fractionation pitch
- Physical state: Red-brownish liquid
- Analytical purity: UVCB.
- Expiration date of the lot/batch: 11 May 2013.
- Radiochemical purity (if radiolabelling):
- Stability under storage conditions: Stable.
- Storage condition of test material: At room temperature in the dark.
- Other:
Density: 0.95 g/cm3 (25°C).
pH: 8-10 at concentration of 5%.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: at least 6 weeks old.
- Weight at study initiation: at least 1.0 kg.
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, Uden, The Netherlands) were available during the study period.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC.
- Humidity (%): 40-70%.
- Air changes (per hr): approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From: July 26, 2012 To: August 02, 2012.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after the removal of the dressings and test substance.

Number of animals:

3 Males.

Details on study design:

TEST SITE
- Area of exposure: 2x3 cm.
- Type of wrap if used: Micropore tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v) (water: Elix, Millipore S.A.S., Molsheim, France; ethanol: Merck, Darmstadt, Germany).
- Time after start of exposure: 4 hours

SCORING SYSTEM:

Erythema and eschar formation:
No erythema.........................................................0
Very slight erythema (barely perceptible).......1
Well-defined erythema.......................................2
Moderate to severe erythema...........................3
Severe erythema (beet redness) *....................4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.

Oedema formation:
No oedema............................................................................................................................................................0
Very slight oedema (barely perceptible)..........................................................................................................1
Slight oedema (edges of area well-defined by definite raising)...................................................................2
Moderate oedema (raised approximately 1 millimeter).................................................................................3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)..............4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Irritation:
Four hours exposure to 0.5 mL of Condensation products of cyclopentanone and pentaldehyde, fractionation pitch resulted in very slight erythema and/or very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals.
Corrosion:
There was no evidence of a corrosive effect on the skin.

Other effects:

Coloration / Remnants:
Brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of the skin reactions.
Toxicity / Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table1: Individual skin irritation scores.

Following exposure, Brown staining of the treated skin area was noted after removal of the test substance.

 

Animal		300^1				299				301
Time after exposure		Erythema (0-4)	Oedema (0-4)	comments		Erythema (0-4)	Oedema (0-4)	comments		Erythema (0-4)	Oedema (0-4)	comments
1 hour		1	0	a		1	1	a		1	1	a
24 hours		0	0	-		0	0	-		0	0	-
48 hours		0	0	-		0	0	-		0	0	-
72 hours		0	0	-		0	0	-		0	0	-

¹Sentinel.

Comments:

a.     Brown staining of the skin by the test substance.

 

Table2: Mean value irritation scores.

Animal		Mean 24, 48 and 72 hrs
		Erythema		Oedema
300		0.0		0.0
299		0.0		0.0
301		0.0		0.0

 

Table3: Animal specifications.

Animal		Sex		Age at start		Body weights (grams)
				(weeks)		prior to application	at termination
300		♂		10-12		2451	2521
299		♂		11-13		2329	2406
301		♂		11-13		2239	2360

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance does not have to be classified.

Executive summary:

The primary skin irritation/corrosion of the substance was determinated according to OECD 404 guideline with GLP. Slight irritation was observed in all three animals (both score: oedema and erythema) in the treated skin areas after four hours with the score 1, this result was fully reversible within 24 hours after exposure in all animals.

There was no evidence of a corrosive effect on the skin.

 

Brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of the skin reactions.

 

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

  

Based on these results Condensation products of cyclopentanone and pentaldehyde, fractionation pitch 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 (2011),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.