Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
In vivo study existed before In-vitro acceptance
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Justification for type of information:
In-vivo study existed prior to REACh registration and prior to the requirement for or acceptance of in-vitro data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: solid, not further specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 2.42-2.85 kg
- Housing: Individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory animal diet (LK-01, pellet diameter 4 mm; 100 g per day), obtained from Hope Farms, Woerden.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-22.0
- Humidity (%): 60-80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated contralateral flank served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Test substance preparation: Approximately 5 g of test substance were scraped from the surface of the solid and transferred into a glass vial; before dose administration the test substance was heated to 60-70 °C, and 3 portions of 0.5 mL were transferred into aluminium vials using a plastic syringe. The portions of test substance were allowed to solidify in the vials. Each portion of test substance was spread on a 6 cm² patch of Metalline and applied to the animals as described below.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL for moistening
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of clipped area of 10 cm x 10 cm on the central back (right flank).
- Type of wrap if used: Test substance was spread on a 6 cm² patch of Metalline (Lohmann, FRG), mounted on permeable tape (Micropore, 3M, St. Paul, USA). Each portion of test substance was moistened with 0.5 mL of Milli-RO water (Millipore Corp., Bedford, Mass. USA). The patch containing the test substance was applied to the right flank of each animal, the left flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, remaining test substance was removed, using a tissue moistened with tap-water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
One hour after dosing the skin of 2 animals showed slight erythema which disappeared within the next 24 hours. Other dermal effects were not observed in any of the animals.
Other effects:
There were no signs of systemic intoxication observed.

Any other information on results incl. tables

Conclusion:

According to the criteria of EU Directive 67/845/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information