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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:
25 August 2009 - 28 August 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of detail on test substance purity; powder was not moistened
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name: Aluminium hydroxide/SH-20 Muster Batch No.: 40/2009CAS No.: 21645-51-2Appearance: Powder/white or light greyAl hydroxide content: not reported.Purity: “suitable chemical purity”Storage conditions: Room temperature (15-25 °C)Manufacture date: 19 March 2009-11-04 Expiry date: UnlimitedSafety precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) Source: Aluminium Oxid Stade GmbHpH of the test item- 5.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALSSource: S&K-LAP Kft., 2173 Kartal, Császár út 135, HUNGARYAge at study initiation: 10 weeks old Body weight range at the beginning of the study: 3328-3698 g.Body weight range at the end of study: 3507-3820 g.Data of receipt: 29 July 2009Acclimation: 27 days Identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.ENVIRONMENTAL CONDITIONSLighting period: 12/12 cycleTemperature:19.2± 22.7 oCRelative humidity: 41-69%Housing/Enrichment: Rabbits were individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm, on 2 levels with a shelf to allow rabbits to climb up to stretch out). Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.Ventilation: 15-20 air exchange/hourThe environmental parameters were recorded twice daily during the acclimatisation and experimental phases.Feeding conditionsDiet: The diet PURINA Base _ Lap gr . diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum. The contents of PURINA Base – Lap gr. diet for rabbits provided.Water: The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin of each animal served as a control.
Amount / concentration applied:
0.5 g of aluminium hydroxide applied to the test area (without vehicle).
Duration of treatment / exposure:
4 hours
Observation period:
Animals examined for erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 males per group
Details on study design:
TEST SITE- Area of exposure: the test item was applied to an approximately 6 cm² area of intact skin - Type of wrap if used: 3 layers of gauzeREMOVAL OF TEST SUBSTANCE- Washing (if done): the test item was removed after the treatment period with water at body temperature. SCORING SYSTEM:The dermal irritation scores were evaluated according to the scoring system by Draize (1959) (see below). Scoring system of erythema and oedema formationErythema and eschar formationNo erythema0Very slight erythema (barely perceptible) 1Well defined erythema2Moderate to severe erythema3Severe erythema (beet redness) to slight escharformation (injuries in depth)4Maximum possible erythema score: 4Oedema formationNo oedema0Very slight oedema (barely perceptible) 1Slight oedema (edges of it will be well definedby definite raising) 2Moderate oedema (raised appr. 1 mm) 3Severe oedema (raised more than 1 mm and extendingbeyond area of exp.) 4Maximum possible oedema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
At observation one hour after patch removal, very slight erythema (score 1) was observed in two animals.At 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.
Other effects:
MortalityThere was no mortality observed during the study.Body weightThere was no effect of treatment on body weight.Clinical observation/General Daily ExaminationThere were no treatment-related clinical signs noted.

Any other information on results incl. tables

TABLE 1. SCORING OF ERYTHEMA FORMATION

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00331/ M

3697

3820

1

0

0

0

00983/ M

3328

3507

1

0

0

0

00892/ M

3540

3603

0

0

0

0

TOTAL

-

-

2

0

0

0

 

TABLE 2. SCORING OF OEDEMA FORMATION

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00331/ M

3697

3820

0

0

0

0

00983/ M

3328

3507

0

0

0

0

00892/ M

3540

3603

0

0

0

0

TOTAL

-

-

0

0

0

0

M       = male

d        = day

h        = hour

 

TABLE 3. MEAN VALUES OF SKIN IRRITATION SCORES

(24, 48, 72 hours reading)

Animal Number

Sex

Erythema

Oedema

00331

male

0.00

0.00

00983

male

0.00

0.00

00892

male

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationAccording to the scoring criteria in OECD 404 test (Acute dermal irritation/corrosion) conducted, Al hydroxide is not a skin irritant/corrosion agent on acute dermal skin contact.Criteria used for interpretation of results: EU
Conclusions:
General toxicityNo clinical signs of general toxicity, mortality and effects on body weight gain were observed in laboratory animals after an acute dermal contact with Al hydroxide (powder).Irritation effectsNo skin irritation/ corrosion effects were reported - no erythema/eschar or oedema were observed in exposed animals 24, 48 and 72 hours after exposure.
Executive summary:

An acute skin irritation study was performed with aluminium hydroxide (SH-20 Muster) in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

 

The test item was administered as supplied, at a single dose of. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

 

After 4 hours, the remaining test item was removed with water at body temperature.

 

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

 

There was no mortality or systemic clinical changes related to Aluminium Hydroxide administration.

 

There was no effect of treatment on body weight.

 

At observation one hour after patch removal, very slight erythema (score 1) was observed in two animals.

 

At 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.

 

As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation.

 

The animals’ individual means scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively.