Registration Dossier

Administrative data

Description of key information

Two irritation studies are available, one for skin irritation/corrosion and one for eye irritation/corrosion. Both studies used rabbits as the test species and conformed to the relevant guidelines, specifically, EU Method B4 and EU Method B5. Both studies were considered to be the key studies.

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
Study period:
7 December 1993 - 14th December 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl acetate
- Physical state: Clear liquid
- Analytical purity: 99.6%
- Lot/batch No.: T521/41/0
- Expiration date of the lot/batch: April 1994
- Storage condition of test material: Room temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 13 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum):ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%.
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period

IN-LIFE DATES: From: 7 December, 1993 To: 14 December, 1993
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 m1

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: 100%
- Type of wrap if used: gauze pad covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Local dermal irritation was assessed using the standard Draize numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The numerical values given to the dermal reactions elicited by Benzyl acetate are shown in the table below.
Very slight to well-defined with or without very slight oedema developed in two animals. These reactions had resolved by Day 4 or 8.
No dermal reactions were seen in the third animal.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

No additional information

Interpretation of results:
GHS criteria not met
Conclusions:
A single semi-occlusive application of Benzyl acetate to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

A study was performed to assess the skin irritation potential of Benzyl acetate to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for a maximum of eight days. A single semi-occlusive application of Benzyl acetate to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. All reactions had resolved by Day 4 or 8. According to Regulation (EC) No. 1272/2008, no classification is warranted.

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
Study period:
20 December 1993 - 11 January 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl acetate
- Physical state:Clear liquid
- Analytical purity: 99.6%
- Lot/batch No.: T52/14/10
- Expiration date of the lot/batch: April 1994
- Storage condition of test material:Room temperature in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 11 to 15 weeks
- Weight at study initiation: 2.6 to 3.4 kg
- Housing: individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%.
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period.

IN-LIFE DATES: From: 20 December 1993 To: 11 January 1994
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml
Duration of treatment / exposure:
no rinsing of the treated eyes
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM:
Ocular irritation was assessed using the prescribed numerical system:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis (Iids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: handheld light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The numerical values given to the ocular reactions elicited by Benzyl acetate are shown in the table below. No corneal damage or iridial inflammation was observed. Temporary well-defined conjunctival reactions only were seen. The eyes were normal two days after instillation.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
OCULAR RESPONSES

Rabbit number and sex

Region of eye

One hour

Day after instillation

1

2

3

4

7

2891 M

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

Redness

2

1

0

0

0

0

Chemosis

1

0

0

0

0

0

2921 M

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

Redness

2

0

0

0

0

0

Chemosis

1

0

0

0

0

0

2922 M

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

Redness

1

0

0

0

0

0

Chemosis

1

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of Benzyl acetate into the rabbit eye elicited transient well-defined conjunctival irritation only. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

A study was performed to assess the eye irritation potential of Benzyl acetate to the rabbit. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation. A single instillation of Benzyl acetate into the eye of the rabbit elicited transient well-defined conjunctival irritation only. All reactions had resolved two days after instillation. According to Regulation (EC) No. 1272/2008, no classification is warranted.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

A study, conducted by Parcell (1994), was performed to assess the skin irritation potential of Benzyl acetate to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for a maximum of eight days. A single semi-occlusive application of Benzyl acetate to intact rabbit skin for four hours elicited very slight to well-defined dermal reactions. All reactions had resolved by Day 4 or 8. According to Regulation (EC) No. 1272/2008, no classification is warranted.

Eye Irritation:

A study conducted by Parcell (1994) was performed to assess the eye irritation potential of Benzyl acetate to the rabbit. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation. A single instillation of Benzyl acetate into the eye of the rabbit elicited transient well-defined conjunctival irritation only. All reactions had resolved two days after instillation.

According to Regulation (EC) No. 1272/2008, no classification is warranted.

Justification for classification or non-classification

Skin Irritation:

Based on the results of the available study, according to Regulation (EC) No. 1272/2008, no classification is warranted.

Eye Irritation:

Based on the results of the available study, according to Regulation (EC) No. 1272/2008, no classification is warranted.