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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 1994-11-15
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

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
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MARLOTHERM L, new
- Substance type: product
- Physical state: liquid
- Storage condition of test material: in a closed container a laboratory hood
- Other: none

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: adult animals, no further details mentioned
- Weight at study initiation: 1.9 - 2.2 kg
- Housing: conventional, single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete 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: 14 days


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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: an adjacent area of untreated skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 48, 72 hours, 6, 8, 10, 14, 17 and 21 days after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm³ of the dorsal area of the trunk
- % coverage: not mentioned
- Type of wrap if used: The application area was covered with a mull patch 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


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 2.89
- Edema: 3.56
Other effects:
dry skin surface, brownish skin discoloration, indurated skin surface, areas of scale, which became fissured and later on detached; one animal showed new smooth skin in places

Any other information on results incl. tables

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

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

30 - 60 min

2/2/2

 4/4/4

24 h

 3/3/3

 3/4/4

48 h

 3/3/3

 3/4/4

72 h

 2/3/3

 2/4/4

Average 24h, 48h, 72h

 2.89

 3.56

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 14 days

 14 days

 

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

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Benzyltoluene is irritating to skin.
Executive summary:

The acute dermal irritation of benzyltoluene was evaluated in rabbits according to OECD 404 guideline. Benzyltoluene was applied undiluted to the skin of 3 Small White Russian rabbits and held in contact for 4 hours by means of a semi-occlusive dressing. Mean scores over 24, 48 and 72 hours for each animal were for erythema and for oedema. Animals were then observed daily until day 15. Average scores (24, 48 and 72 hours) for animals 1, 2 and 3 for erythema were 2.33, 3.0 and 3.0 and for edema were 3.0, 4.0 and 4.0, respectively. These clinical signs were fully reversible within 14 days.