Registration Dossier
Registration Dossier
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EC number: 258-649-2 | CAS number: 53585-53-8
Endpoint summary
Administrative data
Description of key information
The available information demonstrates that Dibenzylbenzene, ar-methyl derivative is only slightly irritating to the skin and not irritating to the eyes or on respiratory tract in animal experiments.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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 - 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. - 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.
Reference
It is noted that cuteanous lesions observed at 24 hours diminished progressively as from then to the 72 -hour readings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 to 24 April 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003
- Deviations:
- yes
- Remarks:
- some parameters, like the age of animals at study initiation, were not reported. Only the 24- and 72-h examination were performed (the 48-h examination was lacking).
- Principles of method if other than guideline:
- Method: other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New-Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: not reported
- Weight at study initiation: 2 - 2.5 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
IN-LIFE DATES: From: 21 April To: 24 April 1981 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- The eyes were not rinsed after administration of the test substance
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
- SCORING SYSTEM: treated eyes were scored for conjunctival lesions and discharge, iris lesions and corneal lesions. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- not irritating
- Other effects:
- No clinical signs were mentioned.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this eye irritation study, the substance should not be classified as irritating to eyes according to the criteria for classification laid down in Directive 67/548/EEC.
- Executive summary:
The eye irritation potential of the substance was determined in rabbits according to method No. 003 of ETAD (Ecological and toxicological of the Dyestuffs manufacturing Industry) from 1976.
A single application of 0.1 ml of dibenzyltoluene in its original form was placed into the cunjonctival sac of the eye of six male New-Zealand rabbits. The eye was not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation.
A few ocular reactions (conjunctival chemosis and enanthema) were observed among the animals however these findings were slight (maximum score of 1) and totally reversible within 48 -72h . Thus, the substance should not be classified as irritating to eyes according to the criteria for classification laid down in Directive 67/548/EEC.
Reference
- Iris was unaffected at any observation time.
- Corneal opacity was noted in one rabbit 24h after instillation. It persisted at 48h but vanished at 72h.
- Conjunctival findings: Redness was observed in all rabbits 1h after instillation (two had a score of 1 and four had a score of 2). At 24h, only one animal still presented a score 1 redness. Afterwards, it was no more observed.
- A grade 2 chemosis was present in 3 animals at 1h. It retroceded and was absent at 24h.
- An important discharge (grade 3) was observed in one rabbit, 3 exhibited a moderate discharge (grade 2) and another one had a slight discharge (grade 1). No discharge were found any more thereafter
- CLINICAL FINDINGS: No observed effects
- MORTALITY: No deaths occurred.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin and eye irritation potential of Dibenzylbenzene, ar-methyl derivative was evaluated in various experiments. All available data demonstrate that the substance has only very slight irritation properties for the skin and no irritation properties for the eyes, with all effects disappearing shortly after treatment.
skin irritation
In the key study, 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.
Eye irritation
In the key study, the eye irritation potential of the substance was determined in rabbits according to method No. 003 of ETAD (Ecological and toxicological of the Dyestuffs manufacturing Industry) from 1976.
A single application of 0.1 ml of dibenzyltoluene in its original form was placed into the cunjonctival sac of the eye of six male New-Zealand rabbits. The eye was not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation.
A few ocular reactions (conjunctival chemosis and enanthema) were observed among the animals however these findings were slight (maximum score of 1) and totally reversible within 48 -72h . Thus, the substance should not be classified as irritating to eyes according to the criteria for classification (CLP).
Respiratory tract irritation
No irritation of the respiratory tract was observed in the acute inhalation studies.
Justification for classification or non-classification
No classification for irritation/corrosion is indicated according to the classification, labeling and packaging (CLP) regulation (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
