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Registration Dossier
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EC number: 258-649-2 | CAS number: 53585-53-8
Skin irritation / corrosion
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- 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
- 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
Constituent 1
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:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- GHS criteria not met
- 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.
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