Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
augustus 2011-september 2011
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 405 (Acute Eye 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: in tightly closed containers between -20 and +40°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: from the animal house facility of IIBAT, Padappai-601, 301 Kancheepuram district, Tamil Nadu, India
- Age at study initiation:
- Weight at study initiation: 2167-2260 g
- Housing: individual in standard stainless steel rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days prior to the experiment in the test room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20.6 and 22.1°C
- Humidity (%): between 57 and 63%
- Air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): The test room was provided with 12h light and 12h dark condition controlled by an automatic timer.

IN-LIFE DATES: From:2011-08-22 To: 2011-09-02

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye instillation of test substance in the left eye; right eye control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
-pH of substance: 7.53
Duration of treatment / exposure:
24 hours following installation
Observation period (in vivo):
72 hours following the installation
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eyes of test animals were washed
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: Draize's method (conjunctiva, cornea and iris)

TOOL USED TO ASSESS SCORE: ophtalmoscope

EXAMINATION: the animals were examined at 1, 24, 48 and 72h after instillation of the test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The maximum mean score for ocular lesions observed in the experiment was 4.00 only at 1 hour. The ocular lesions decreased and the mean score became 0 at 24, 48 and 72 hours after instillation. Hence, under the experimental conditions the test substance, bis(2-butoxyethyl)adipate (Proviplast 0142), was mnimally irritating to the eyes of the New Zealand white rabbits.
Executive summary:

Acute eye irritation/corrosion potential of bis(2 -butoxyethyl)adipate was tested in female New Zealand white rabbits. In the initial test 0.1 ml of test substances was instilled into the conjunctival sac of the left eye of one rabbit, followed by confirmation in 2 additional rabbits. The right eye of the rabbits served as the control. The eyes of initial and confirmatory test animals were examined and ocular lesions were graded after instillation of the test substance at 1, 24, 48 and 72h. The ocular irritation potential was evaluated bu Draize's method. Test substance treated eye (left) of initial and confirmatory test animals exhibited conjunctival lesions at 1 hour, and cleared at 24h of the observation period.

The maximum mean score for ocular lesions observed in the experiment was 4.00 +/- 0.0 only at 1 hour after instillation. Hence, under the experimental conditions the test substance, bis(2 -butoxyethyl)adipate, was minimally irritating to the eyes of the New Zealand white rabbits, however below the threshold of classification.