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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-12 to 2010-05-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2008
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): KEMFLUID EQ
- Substance type: Fatty acids, C10-20 and C16-18-unsatd., reaction products with triethanolamine, di-Me sulphate-quaternized
- Physical state: yellowish solid paste
- Composition of test material, percentage of components: 100 % (solvent - free)
- Lot/batch No.: 42
- Expiration date of the lot/batch: 26.07.2010
- Storage condition of test material: room temperature, dry and dark
- Other: pH approx. 3 (5 % in IPA/H2O)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Age at study initiation: not data
- Weight at study initiation: 2028, 1951 and 1978 g
- Housing: housing in single steel cages
- Diet (e.g. ad libitum): Altromin 2023 Maintenance diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from municipal source, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): dimmed daylight

IN-LIFE DATES: From: To: 2010-04 -07 to 2010-05 -04

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The right flank remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1 hour and 24, 48, 72 hours 7, 14 and 21 days after application of the test substance.
Number of animals:
3 animals, 1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: Samples of 0.5 g of the test substance have been put on a gauze pad and spread over an area of 2 cm x 3 cm; the gauze pad then was applied to the skin.
- % coverage: One gauze pad of 4 cm x 5 cm size (Askina® Brauncel, B. Braun Petzold GmbH, Melsungen, Germany) with test substance was applied to the left flank of one animal. It was held in place by strips of Micropore (3M company, St. Paul, USA). The semi-occlusive dressing was bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure skin was cleaned carefully with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: as stipulated by OECD guideline 404, 2002

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Symptoms of skin irritation (erythema and edema) were observed until 7 days after application. Well-defined erythema and slight edema formation
(grading 1 or 2 in each case) were observed within 72 hours after patch removal in two animals. In one animal only very slight, barely perceptible
erythema and edema occurred. 7 days after patch removal, very slight erythema and edema (grading 1) were still existent in two animals, which was
reversible after 14 days. In addition, slight desquamation was observed in all three animals at observations at 72 hours, 7 days and 14 days after
application. 21 days after application, all three animals were without any sign of skin irritation.

Other effects:
No symptoms of toxicity caused by the test substance or any unusual finding were observed.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/2/1

0/0/0

24 h

2/2/1

1/1/0

48 h

2/2/1

2/2/1

72 h

2/2/1

2/2/1

7 days

1/1/0

1/1/0

14 days

0/0/0

0/0/0

Average 24h, 48h, 72h

2/2/1

1.67/1.67/0.67

Reversibility*)

c/c/c

c/c/c

Average time (unit) for reversion

14 days

14 days

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Desquamation persists at the 14 day observation, but was fully reversible at study day 21.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met