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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
Study period:
21 to 24 April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2c: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003 - 1976
Deviations:
yes
Remarks:
only the 24- and 72h- examination were performed (the 48h -examination time is lacking) and some parameters like the age of animals at study initiation were not reported.
Principles of method if other than guideline:
Method: other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibenzylbenzene, ar-methyl derivative
EC Number:
258-649-2
EC Name:
Dibenzylbenzene, ar-methyl derivative
Cas Number:
53585-53-8
Molecular formula:
C21H20
IUPAC Name:
dibenzylbenzene, ar-methyl derivative
Test material form:
liquid
Details on test material:
Test was performed with dibenzyltoluene, new name: dibenzylbenzene, ar-methyl derivative

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, France (76410 Saint-Aubin-les-Elbeuf)
- Age at study initiation: not reported
- Weight at study initiation: 2.3 +/- 0.1 kg
- Housing: individually in polystyrene cage (0.55 mm x 0.35 mm x 0.32 mm)
- Diet (e.g. ad libitum): commercial diet
- Water (e.g. ad libitum): ad libitum in 1500- or 2000-mL feeding bottle
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 50+/-20
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The right and left flanks were shaved 24 h before treatment. In addition the left flank was incised.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 and 72 hours (and 7 days later if necessary).
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square for the left flank, not reported for the right flank
- % coverage: not reported
- Type of wrap if used: a gauze square is maintained on the zone of application by an impermeable plastic band, an elastic tubular band and fragments of adhesive wraps


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, the residual was wiped with a dry gauze patch
- Time after start of exposure: 24 h


SCORING SYSTEM: skin erythema and oedema were noted from 0 (no observation) to 4 (severe)

OTHER EXAMINATIONS:
- Clinical signs: daily observed
- Mortality: daily observed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: animals 1,2,3,4
Time point:
other: 24h/72h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Both scores on right and left flank are added
Irritation parameter:
erythema score
Basis:
other: animals 1,2,3,4
Time point:
other: 24 /72h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Left flank (shaved and incised)
Irritation parameter:
edema score
Basis:
other: animals 1,2,3,4
Time point:
other: 24h /72h
Score:
0
Max. score:
0
Reversibility:
other: no sign
Remarks on result:
other: Left flank (shaved and incised)
Irritation parameter:
erythema score
Basis:
other: animals 1,2,3,4
Time point:
other: 24h/ 72h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Right flank (shaved but not incised)
Irritation parameter:
edema score
Basis:
other: animals 1,2,3,4
Time point:
other: 24h /72h
Score:
0
Max. score:
0
Reversibility:
other: no sign
Remarks on result:
other: Right flank (shaved but not incised)
Irritant / corrosive response data:
Slightly irritant
Other effects:
CLINICAL SIGNS: No observed effects.
MORTALITY: No deaths occured.

Any other information on results incl. tables

It is noted that cuteanous lesions observed at 24 hours diminished progressively as from then to the 72 -hour readings.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU and CLP-GHS
Conclusions:
The substance was found to be slightly irritating to rabbits skin with some slight erythema (maximum score 1). The observed cutaneous reactions were decreased at 72h observation time when compared to the 24h observation time.
Consequently, the substance should not be classified as irritating to skin according to EC criteria for classification of dangerous substances.
Executive summary:

The dermal irritation potential of Dibenzylbenzene, ar-methyl derivative was determined in rabbits according to ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n° 003 (1976). Twenty-four hours before treatment; the flanks of six male New-Zealand rabbits were carefully shaved and the left sides were slightly scarified. Dibenzyltoluene was applied at the dose-level of 0.5 g per flank and was held in contact with the scarified and the intact skin for 4 hours by a semi-occlusive dressing.

Slight erythema was observed 24 and 72 hours after the removal of the dressing however the observed cutaneous reactions were decreased at the 72h observation time when compared to the 24h observation time.

Consequently, the substance was found to be slightly irritant but should not be classified as irritating to skin according to EC criteria for classification of dangerous substances.