Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to GLP and state of the art and actual methods and is therefore considered reliable, relevant and adequate.
Justification for type of information:
The DBEA dossier contains old in vivo studies , which are not allowed today. Therefore a justification needs to be added in the end point data summary.
The new legal requirements (21 June 2016) require an in vitro skin irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 T/y tonnage band. Therefore there is no need to repeat the study using the alternative test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Proviplast 0142 (bis(2-butoxyethyl)adipate)
- Chemical Name: Bis(2-butoxyethyl)adipate
- Substance type: liquid
- Physical state: clear liquid with a very faint odour
- Analytical purity:98,83%
- Composition of test material, percentage of components: see confidential details
- Purity test date: 2011-07-11
- Lot/batch No.:11701913 SA
- Expiration date of the lot/batch: 2012-12-14
- Storage condition of test material: store in tightly closed containers between -20 and +40°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from the animal house facility of IIBAT, Padappai-601 301, Kancheepuram district, Tamil Nadu, India
- State at study initiation: nulliparous and non pregnant
- Weight at study initiation: 2099-2153g
- Housing: individually in standard stainless steel rabbit cages
- Diet (e.g. ad libitum): standard pellet feed was provided ad libitum
- Water (e.g. ad libitum): UV treated water was provided ad libitum
- Acclimation period: five days prior to experiment in the test room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20.6 and 22.1°C
- Humidity (%): between 58 and 63%
- Air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark

IN-LIFE DATES: From: 19.08.2011 To: 30.08.2011

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
-pH of substance: 7.53
Duration of treatment / exposure:
4h exposure period
Observation period:
72 hours
Number of animals:
3 females (nulliparous and non pregnant)
Details on study design:
TEST SITE
- Area of exposure: about 6 square cm on both sides of the dorsal surface of the trunk of the animal (left side)
- % coverage: 6 square cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was removed, using water without altering the existing response or the integrity of the epidermis
- Time after start of exposure: at the end of the 4h exposure period

SCORING SYSTEM: The dermal responses (erythema and oedema) were scored at 60 minutes, and then at 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
other: primary dermal irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0.25
Max. score:
4
Irritation parameter:
other: primary dermal irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
From the above results, it was concluded that the test substance bis(2-butoxyethyl)adipate, Proviplast 0142, was slightly irritant to the skin of New Zealand White rabbits under the eperimental conditions tested.
Executive summary:

Acute dermal irritation/corrosion potential of Proviplast 0142, bis(2 -butoxyethyl)adipate, was tested in female New Zealand White rabbits. A volume of 0.5 ml of test substance was evenly applied as such to the 6cm2 clipped skin area on the left side of the rabbits under a gauze patch. The right untreated side was kept as control area. At the end of 4th, the gauze patch was removed and application site was wiped with water without altering the integrity of the epidemis to remove the residual test substance, first in one animal and later repeated to confirm in 2 additional animals. The test site was covered with semi occlusive gauze patch. Animals were observed for erythema and oedema at 60 minutes, 24, 48 and 72h following the removal of gauze patch. Initial and confirmatory test animals exhibited very slight erythema at 60 minutes and completely cleared at 24h observation period. The acute demal irritation (Primary Irritation) Index was calculated as 0.25 (including the 1h observation) and 0 (excluding the 1h observation). No dermal reaction was seen in untreated area of initial and confirmatory test animals.

Hence, it was concluded that the test substance Proviplast 0142 (bis(2 -butoxyethyl)adipate) was slightly irritating to the skin of New Zealand white rabbits under the experimental conditions tested, however below threshold of classification.