Registration Dossier

Administrative data

Description of key information

'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' causes no irritating effects on the skin of rabbits nor on the eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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
Vehicle:
unchanged (no vehicle)
Controls:
other: The opposite untreated eye served as control.
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
once
Observation period (in vivo):
up to 21 days
Number of animals or in vitro replicates:
3
Details on study design:
100 µl test compound was instilled into the conjunctival sac of one eye of each of three rabbits after gently pulling the lowere lid away from the eyeball. The lids were then gently held together for avout one second. The other eye remained untreated and served as control. The treated eye was washed out tith physiological saline 24 hours after the instillation of the test compound . The animals were observed for 21 days.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = o at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
The 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' can be regarded as not irritating to the eye.
Interpretation of results:
GHS criteria not met
Executive summary:

A study for irritant / corrosive potential on the rabbit's eye was conducted with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' in accordance with the OECD Guideline for testing of chemicals No. 405.

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 eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin and eye irritation /corrosion

A study for irritant / corrosive potential on the rabbit's skin and eye was conducted with 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' in accordance with the OECD Guideline for testing of chemicals No. 404 and 405. 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 and not irritating to the eye.

Overall, the studies are GLP compliant and of high quality (Klimisch score = 1). Therefore, there is no reason to believe that the above described results would not be applicable to humans.


Justification for selection of skin irritation / corrosion endpoint:
This is the only available study: guideline study and GLP with Klimisch score 1.

Justification for selection of eye irritation endpoint:
This is the only available study: guideline study and GLP with Klimisch score 1.

Justification for classification or non-classification

'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' causes no irritating effects on the skin of rabbits nor on the eye of rabbits.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.