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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:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD guideline 404 and GLP conditions not specified.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive 84/449/EEC
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid - liquid: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Aluminiumhydroxichlorid
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): confidential
- Composition of test material, percentage of components: confidential
- Lot/batch No.: AZAH485
- Stability under test conditions: no data
- Storage condition of test material: At 22 °C in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: Individually
- Diet: ad libitum Altromin 2123 rabbit diet
- Water: ad libitum deionized, chlorated water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Remarks:
0.9% NaCl solution
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 ml
- Concentration (if solution): 500 mg in 0.3 ml
Duration of treatment / exposure:
4 hours
Observation period:
Not specified
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Approx. 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal region of the trunk with an electric hair clipper on an area of approx. 25 cm2. Only animals with intact skin were used. Each animal was fixed on the prepared skin site with a wound plaster with 2.5 x 2.5 cm. The area was covered with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining test substance removed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
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:
No irritant/corrosive response observed 30 min, 60 min, 24 h, 48h, 72h after removal of the patch.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance Tanfix AL is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

A skin irritation study was performed according to OECD Guideline 404. 500 mg of test substance was applied to the clipped skin in 0.3 ml of physiological saline of three New Zealands White rabbits under a semi-occlusive cover. After a 4-hour exposure period, the remaining test substance was removed with lukewarm tap water. No reactions were observed.

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 /0.0 for erythema and 0.0 / 0.0 / 0.0 for edema.

Under the test conditions, the test substance Tanfix AL is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.