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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:
01 - 04 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an established protocol and similar to an appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Unislip 1753
- Physical state: solid
- Storage condition of test material: room temperature in the dark
- Analytical purity: 99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adults
- Housing: Animals were individually housed in plastic cages with a perforated floor
- Diet: 100 g per day (LK-01 and LK-04) standard laboratory animal diet (Hope Farms, Woerden, The Netherlands)
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% (w/v)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of the left flank of the animals
- Type of wrap if used: The test substance was spread on a patch of Metalline and mounted on permeable tape. This was applied to the left flank of each animal, the right flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
other: mean of 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test substance caused only very slight erythema in all three animals 1 h after removal of the test substance and were fully reversible within 24 hours post-application. Neither edema nor any signs of systemic toxicity were observed in any of the rabbits during the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

A sample of Unislip 1753 was tested in the rabbit primary dermal irritation/corrosion test to determine its possible irritating or corrosive effects.

The flank skin of 3 albino rabbits was exposed to 0.5 gram of the test substance moistened with 0.5 ml Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused only very slight erythema in all three animlas, 60 minutes after removal of the dressings.

The primary skin irritaiton index amounted to 0. Based on these results, the test substance should be considered as minimally irritating to the skin.

According to the criteria laid own in Annex VI of the EEC Council Directive 76/548/EEC (amended by Directive 832/467/EEC), the test substance need not be labelled as a skin irritant.