Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The restriction is due to the use of the read across approach: the test was performed not with 3-PPB but with Benzyl benzoate, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Clear liquid
Details on test material:
No details presented in study report
RIFM/II = TAC 84/2-21 = benzyl benzoate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.2
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.