Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester. 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:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
scarified skin was also tested
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
yes
Remarks:
scarified skin was also tested
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetraoctanoate de Pentaerythritol
- Analytical purity: not reported
- Storage condition of test material: room temperature in sterile bottle

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CARON-St GermainLaxis, 77950 Maincy, France
- Sex: male
- Weight at study initiation: about 2.5 - 3 kg
- Housing: in individual polysterene cages of standardized dimensions with perforated floor
- Diet: ALIMENT EXTRALABO C15 Ets Pietrement (77482 Provins), ad libitum
- Water: tap water provided in sterilized makrolon bottles equipped with stainless steel pipettes, ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 50 - 80
- Air changes (per hr): 3000 m³
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, 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
Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 4, 24, 48 and 72 h and 4 and 7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: left side (intact) and right side (scarified9) of the animal
- Site preparation: before the test, the skin sites were shaved with shears in order to cover a surface of about 14x14 cm. While the left side was intact, three parallel scarifications about 2.5 cm long were created on the right site.
- Type of wrap if used: sterile gauze patch (2.5x2.5 cm) held in place by adhesive strips (10 cm wide; Urgocrepe Fournier)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any trace of substance was eliminated with distilled water or, if necessary, with 5% SDS solution followed by careful rinsing
- Time after start of exposure: 4 h

SCORING SYSTEM:
Acc. to method outlined in the Official French Gazette of 21 Feb 1982, Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out 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: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: intact skin
Irritant / corrosive response data:
While one animal showed an slight edema reaction on the intact and scarified skin 4 hours after application, another animal had a slight edema reaction on the intact skin 24 h after application. From 48 h on, all animals showed no skin reactions.

Any other information on results incl. tables

Results:

Time Animal Intact skin
Erythema Edema Necrosis Corrosion Desquamation
4 h 1070 0 0 0 0 0
1071 0 0 0 0 0
1072 0 1 0 0 0
24 h 1070 0 0 0 0 0
1071 0 1 0 0 0
1072 0 0 0 0 0
48 h 1070 0 0 0 0 0
1071 0 0 0 0 0
1072 0 0 0 0 0
72 h 1070 0 0 0 0 0
1071 0 0 0 0 0
1072 0 0 0 0 0
4 days 1070 0 0 0 0 0
1071 0 0 0 0 0
1072 0 0 0 0 0
7 days 1070 0 0 0 0 0
1071 0 0 0 0 0
1072 0 0 0 0 0
mean 24 - 72 h 1070 0 0 0 0 0
1071 0 0.3 0 0 0
1072 0 0 0 0 0
mean 0 0.1      

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