Benzyl benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and Test Guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl benzoate

EC Number:

204-402-9

EC Name:

Benzyl benzoate

Cas Number:

120-51-4

Molecular formula:

C14H12O2

IUPAC Name:

benzyl benzoate

Constituent 2

Reference substance name:

RIFM II

IUPAC Name:

RIFM II

Test material form:

other: clear liquid

Details on test material:

No details presented in study report
RIFM/II = TAC 84/2-21 = benyl benzoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A Smith , Warlingham, Surrey
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in anodised aluminium caging with grid flooring
- Diet (e.g. ad libitum): Dalgety-Spillers pelleted rabit diet ref. 680 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 42-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 April 1985 To: 23 April 1985

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL applied to dorsum of each of four rabbits

Duration of treatment / exposure:

4 hour exposure

Observation period:

7 days

Number of animals:

4

Details on study design:

Four rabbits were treated simultaneously with four test materials (two per flank placed distally and caudally on the shaved dorsum). 0.5 mL of undiluted test material was applied to a square of surgical lint whicwas held in situ on the rabbit by means of an encircling elasticated adhesive bandage. The dressing was removed after four hours (treated sites were swabbed with cotton wool and warm water to remove residual material immediately after removal of the dressing) and treated sites assessed after 1, 24, 48, 72 and 168 hours for signs of dermal change that was scored using the standard Draize assessment scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: completely resolved within 7 days for 3 of the 4 rabbits

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Three of the four treated sites showed evidence of slight erythema within an hour of the dressing removal. For two of these rabbits well defined erythema developed over the following 72 hours with slight reactions remaining for the third rabbit. slight erythema persisted for seven days in one animal but was showing a degree of amelioration over the study time course although not fully resolved by termination. No reactions developed in one rabbit throughout the study.
Very slight oedema was observed for three rabbits but the reactions did not progress in severity and resolved with 48 or 168 hours.

Other effects:

None observed

Any other information on results incl. tables

Dermal reactions with benzyl benzoate

Rabbit number	1 hr	24 hr	48 hr	72 hr	168 hr
591
Erythema Oedema	0 0	0 0	0 0	0 0	0 0
596
Erythema Oedema	1 1	2 1	2 0	1 0	0 0
598
Erythema Oedema	1 1	1 1	1 0	1 0	0 0
600
Erythema Oedema	1 1	2 1	2 1	2 1	1 0
Mean		Erythema = 1.2 Oedema = 0.4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Generally slight or very slight erythema or oedema was apparent in three of four treated rabbits, with reactions persisting for three days but typically resolved by day 8. Mean scores for erythema and oedema assessed over the 24 to 72 hour assessments were less than 2.0 and did not trigger classification thresholds for benzyl benzoate.

Executive summary:

Four rabbits were each treated with four test materials on four dorsal locations, for an exposure period of 4 hours. After removal of the semi-occlusive dressing the sites were swabbed with cotton wool and warm water to remove test material residues. Dermal assessments were recorded 1, 24, 48, 72 and 168 hours after removal of the dressing. Generally slight or very slight erythema or oedema was apparent in three of four rabbits treated with benzyl benzoate, with reactions persisting for three days but typically resolved by day 8. Mean scores for erythema and oedema assessed over the 24 to 72 hour assessments were less than 2.0 and did not trigger classification thresholds for benzyl benzoate.