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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
From 28 February 2000 to 27 October 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Screening test: only one animal is tested, no certificate of analysis included
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid at ambient temperature
Details on test material:
- Name of test material (as cited in study report): Dermalcare MAP L-213/K
- Physical state: clear liquid
- Stability under test conditions: assumed to be stable by the sponsor
- Storage condition of test material: ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A
- Age at study initiation: no data
- Weight at study initiation: 2.3 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

VEHICLE
not applicable
Duration of treatment / exposure:
4h
Observation period:
7 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- % coverage: no data
- Type of wrap if used: test item was spread on a gauze square, placed onto the animal's skin and held in place by encircling the trunk of the animal with a length of elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
not applicable

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Erythema was observed in the tested animal, but not edema (see table 7.3.1/1)
Other effects:
none

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data at each observation time after each exposure time.

Score at time point (from the start of exposure) / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

1 h

0

0

24 h

2

0

48 h

2

0

72 h

2

0

7 days

0

0

Average 24h, 48h, 72h

2.0

0.0

Reversibility*)

c

-

Average time (day) for reversion**

7

-

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

**) Corresponds to the last day on which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the one tested rabbit (screening test) does not allow to classify Dermalcare MAP L-213/K as a skin irritant according to the crieria of the Regulation (EC) 1272/2008 (CLP) but allows to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.
Executive summary:

In a dermal irritation screening study performed similarly to the OECD guideline No. 404, one New Zealand White rabbit was dermally exposed to 0.5 mL of undiluted Dermalcare MAP L-213/K on a part of the trunk (6.25 cm²).Test site was covered with a semi-occlusive dressing for 4hours. The animal was then observed for 7 days. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.

The mean score calculated within 3 scoring times (24, 48 and 72 hrs) was 2.0 for erythema and 0.0 for edema.

 

Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the only one tested rabbit (screening test) do not permit to classify Dermalcare MAP L-213/K as a skin irritant according to the criteria of the Regulation (EC) 1272/2008 (CLP) but permit to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.