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Diss Factsheets

Administrative data

Description of key information

The substance pentaaluminium triyttrium dodecaoxide is not irrittaing to the skin and not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-12-13 to 2011-01-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 24 weeks
- Weight at study initiation: 4.4 kg, 4.3 kg, 4.8 kg
- Housing: Semi barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2010-12-08 To:2010-12-20
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: The untreated right body sight served as control. In order to confirm the negative response, two additional animals were treated with a patch without the test item.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): enough for moistening the test item
- Purity: ca. 100 %
Duration of treatment / exposure:
Initial test: 4h
Main test: 4 h
Observation period:
The animals were examined for signs of erythema and oedema 1 h after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.
Number of animals:
Initial test: 1
Main test: 3
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 72 h

SCORING SYSTEM: Erythema and eschar formation, oedema form
Irritation parameter:
erythema score
Basis:
other: animals 2 and 3
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: animals 2 and 3
Time point:
other: 24 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: animals 2 and 3
Time point:
other: 48 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: animals 2 and 3
Time point:
other: 72 h
Score:
0
Irritation parameter:
edema score
Basis:
other: animals 1, 2 and 3
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
other: animals 1, 2 and 3
Time point:
other: 24 h
Score:
0
Irritation parameter:
edema score
Basis:
other: animals 1, 2 and 3
Time point:
other: 48 h
Score:
0
Irritation parameter:
edema score
Basis:
other: animals 1, 2 and 3
Time point:
other: 72 h
Score:
0
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: animals 1, 2 and 3
Time point:
other: 1h
Score:
0
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: animals, 1, 2 and 3
Time point:
other: 24 h
Score:
0
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: animals 1,2 and 3
Time point:
other: 48 h
Score:
0
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: animals 1, 2 and 3
Time point:
other: 72 h
Score:
0
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Initial test.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Remarks on result:
other: Initial test.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Remarks on result:
other: Initial test.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Remarks on result:
other: Iniital test.
Irritant / corrosive response data:
The initial test in animal no.1: The examination of the test site immediately after the patch removal revealed erythema grade 1, the subsequent clinical observation showed erythema grade 1 after 1 h, but no corrosive effects.
The test item showed neither irritant nor corrosive effects on the intact skin in the other 2 animals at any time.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant, not corrosive.
Executive summary:

Under the conditions of the study the single dermal application of the test item L181 to rabbits at a dose of 0.5 g showed slightly irritant but no corrosive effects in one animal, which were fully reversible within 24 h.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the criteria for classification and labeling requirements of the CLP-regulation 1272/2008 (as well as the DSD 2001/59/EC), the test item L181 does not have to be classified and has no obligatory requirement for skin irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The variation L181 was tested for the potential to cause skin irritation in a GLP guideline studies according to OECD 404.

The substance did not exhibit skin irritation or skin corrosion.

The same profile is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.

The variations L181 and L175G25C4G were tested for the potential to cause eye irritation in a GLP guideline studies according to OECD 405.

Both variations did not exhibit eye irritation or eye corrosion.

The results of the 2 studies on eye irritation reveal the same profile for both variations. The same result is expected for other variations of the substance pentaaluminium triyttrium dodecaoxide.


Justification for selection of eye irritation endpoint:
Both studies were selected.

Justification for classification or non-classification

Pentaaluminium triyttrium dodecaoxide did not show any potential to cause dermal irritation or dermal corrosion.

Pentaaluminium triyttrium dodecaoxide did not show any potential to cause eye irritation or eye corrosion.

C&L is not required.