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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 in animal experiments.

No classification as irritant is justified.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-10-24 to 1994-11-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: Small white Russian, Chbb:HM, SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: young healthy adults, no further details mentioned
- Weight at study initiation: Animal 1: 2.1 kg, animal 2: 2.2 kg, animal 3: 2.3 kg
- Housing: conventionally, one animal/steel cage
- Diet (e.g. ad libitum): K 4, Special feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12

IN-LIFE DATES: From: 1994-10-24 To: 1994-11-04
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
up to 10 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a gauze patch was placed, which was secured in place with a non-irritating plaster. The patch was held in contact with the skin by a suitable semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.33
Max. score:
8
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.44
- Edema: 0.89
Other effects:
Two aninmals showed a dry skin surface with scale formation.

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score:

Max. score:

60 min

2/2/2

2/2/1

24 h

2/2/2

2/2/1

48 h

1/2/2

0/1/1

72 h

0/1/1

0/1/0

Average 24h, 48h, 72h

1.44 

 0.89

Reversibility*)

 c.

c. 

Average time (unit) for reversion

6 d 

 6 d

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was found to be only slightly irritating, not fulfilling the criteria for classification.
Executive summary:

The test substance was tested for skin irritation in rabbits in an OECD 404 guideline study and was found to be only slightly irritating under the conditions of the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-11-07 to 1994-11-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
other: Small White Russian, Chbb:HM, SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: young healthy adults, no further details mentioned
- Weight at study initiation: Animal 1: 2.3 kg, animal 2: 2.4 kg, animal 3: 2.2 kg
- Housing: conventionally, one animal/steel cage
- Diet (e.g. ad libitum): K 4, Special feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12

IN-LIFE DATES: From: 1994-11-07 To: 1994-11-11
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm phyiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 24 hours after administration
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0
- Conjuntivae (Chemosis): 0
Other effects:
After 1 hour all animals showed hyperamic blood vessels and a slight swelling of the conjuctivae, furthermore discharge different from normal were observed. Cornea and iris showed no changes.

Table 1: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 0

Max. score: 0

Max. score: 1

Max. score: 1

60 min

0/0/0

0/0/0 

1/1/1 

1/1/1 

24 h

0/0/0

0/0/0 

0/0/0 

0/0/0

48 h

0/0/0

0/0/0 

0/0/0 

0/0/0

72 h

0/0/0

0/0/0 

0/0/0 

0/0/0

Average 24h, 48h, 72h

 0

 0

 0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

 

 

 c.

 c.

Average time (unit) for reversion

 

 

 

 

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was found to be only very slightly irritating shortly after treatment, not fulfilling the criteria for classification. All effects disappeared shortly after treatment.
Executive summary:

The test substance was tested for eye irritation in rabbits in an OECD 405 guideline study and was found to be only very slightly irritating shortly after test substance application. No effects were observed at observation times 24hr, 48hr and 72 hr after application.

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.


Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

No classification for irritation/corrosion is indicated according to the general classification and labeling requirements for dangerous substances and preparations (67/544 EEC) or the classification, labeling and packaging (CLP) regulation (EC 1272/2008).