Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
13 Apr - 30 Apr 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters
- Physical state: clear amber liquid
- Analytical purity: 100%
- Lot/batch No.: 1548
- Expiration date of the lot/batch: 28 January 2011 (allocated by NOTOX, 1 year after receipt of the test substance)
- Storage condition of test material: RT in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: 7-14 weeks
- Weight at study initiation: 1602 - 2455 g
- Housing: Animals were individually housed in labelled 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: Pelleted, Global Diet 2030 (Harlan Teklad®, Mucedola, Milanese, Italy), approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 18.6 – 19.3)
- Humidity (%): 40-70 (actual range: 43 - 73)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 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: 6 cm² on the dorsal area of the skin
- Type of wrap if used: metalline patch of 2x3 cm mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage (Lohmann GmbH, Neuwied, Germany (Metalline) and 3M, St. Paul, Minnesota, U.S.A. (Micropore and Coban))

REMOVAL OF TEST SUBSTANCE
- Washing: 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: 4h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Edema (score = 1) were seen in all animals 1 h after exposure only.
Irritant / corrosive response data:
Four hours exposure to 0.5 mL of Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters resulted in very slight erythema (fully reversible within 48 h) and very slight edema (fully reversible within 24 h) in the treated skin areas of the three rabbits. The skin irritation resolved within 48 hours after exposure in all animals. There was no evidence of a corrosive effect on the skin.




Other effects:
Sticky remnants of the test substance were present on the skin immediately after removal of the test substance and dry remnants of the test substance were present at the 1 hour observation time point. No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified