Registration Dossier
Registration Dossier
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EC number: 947-361-9 | CAS number: -
Skin irritation / corrosion
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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized
- EC Number:
- 931-203-0
- Cas Number:
- 157905-74-3
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
- 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 or test system 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
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