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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:
1994-10-24 to 1994-11-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: 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

Test system

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

Results and discussion

In vivo

Results
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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.