Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl 2-ethylhexyl adipate
EC Number:
261-234-9
EC Name:
Benzyl 2-ethylhexyl adipate
Cas Number:
58394-64-2
Molecular formula:
C21H32O4
IUPAC Name:
benzyl 2-ethylhexyl adipate
Constituent 2
Chemical structure
Reference substance name:
Bis(2-ethylhexyl) adipate
EC Number:
203-090-1
EC Name:
Bis(2-ethylhexyl) adipate
Cas Number:
103-23-1
Molecular formula:
C22H42O4
IUPAC Name:
bis(2-ethylhexyl) adipate
1
Chemical structure
Reference substance name:
Dibenzyl adipate
EC Number:
219-516-4
EC Name:
Dibenzyl adipate
Cas Number:
2451-84-5
Molecular formula:
C20H22O4
IUPAC Name:
dibenzyl adipate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.1 - 3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The opposite site of the back served as control.
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 h
Observation period:
up to 14 days
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: semi-osslusive

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

SCORING SYSTEM:
according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time points
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
not determinable
Irritant / corrosive response data:
'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

A study for irritant / corrosive potential on the rabbit's skin was conducted with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' in accordance witz the OECD Guideline for testing of chemicals No. 404. Based on the obtained results 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the skin.