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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with internationally recognised test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisobutyl hexahydrophthalate
EC Number:
275-069-5
EC Name:
Diisobutyl hexahydrophthalate
Cas Number:
70969-58-3
Molecular formula:
C16H28O4
IUPAC Name:
bis(2-methylpropyl) cyclohexane-1,2-dicarboxylate
Details on test material:
- Name of test material : DIBE (diisobutylhexahydrophthalate)
- Physical state: Liquid
- Lot/batch No.: T60211/349
- Expiration date of the lot/batch: December 2013
- Storage condition of test material: room temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 41 - 43 weeks
- Weight at study initiation: 4.3 - 5.2 kg
- Housing: single housing in polycarbonate/stainless steel cages
- Diet (e.g. ad libitum): Stanrab (P) SQC from Special Diet Services available ad libitum
- Water (e.g. ad libitum): Municipal supply available ad libitum
- Acclimation period: at least 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2013-01-27 To: 2013-02-12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted (as supplied)

VEHICLE
- Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm area of skin clipped free of hair on the dorsal and lateral parts of the trunk of the animals
- % coverage: Not applicable to test method
- Type of wrap if used: Surgical gauze tape 25 x 25 mm (soaked with test substance) held in place by non-irritating tape. The application area was then immobilised with an elastic adhesive dressing acting as a semi-occlusive barrier

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scale according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: n/a
Irritant / corrosive response data:
No erythema or oedema was recorded in all animals approximately 1 hour after treatment. Well defined erythema (score 2) was observed in all animals approximately 24, 48 and 72 hours after dosing. Animals showed slight erythema (score 1) at observation performed on Day 8 of the study. Recovery occurred in all animals at the end of the observation period (Day 15).

AVERAGE SCORE
- Erythema: 2.0
- Edema: 0.0
Other effects:
There was no indication of a systemic effect

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time of each animal from the test

Time point

Erythema

Oedema

Max. score: 4

Max. score: 4

60 minutes

0/0/0

0/0/0

24 hours

2/2/2

0/0/0

48 hours

2/2/2

0/0/0

72 hours

2/2/2

0/0/0

7 days

1/1/1

0/0/0

14 days

0/0/0

0/0/0

Average 24, 48 and 72 hours

2.0

0.0

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No systemic effects were observed. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.
Executive summary:

Dermal irritation following a 4 hour exposure period has been assessed in accordance with OECD/EU test methods.

No systemic effects were observed. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.

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