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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:
2008-12-03 to 2008-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-compliant study under GLP without deviations.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Beryllium Metal Powder
- Molecular formula (if other than submission substance): Be
- Substance type: Metal
- Physical state: Solid
- Analytical purity: 99.4 %
- Lot/batch No.: O-30H grade /Blend # 051106
- Expiration date of the lot/batch: 2050-12-31
- Storage condition of test material: at room temperature protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS Young Adult New Zealand White, SPF
- Source: Harlan Laboratories, Horst, The Netherlands
- Age at study initiation: 17 weeks (male), 16 weeks (females)
- Weight at study initiation: 2416 g (male), 2089-2408 g (females)
- Housing: individually in steel cages with haysticks
- Diet (e.g. ad libitum): pelleted standard rabbit diet ad lib., Provimi Kliba, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): community tap water ad lib.
- Acclimation: under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g unchanged material
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: left flank
- coverage: 2.5 x 2.5 cm
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer bandage wrapped around the abdomen


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 4h


SCORING SYSTEM: numerical scoring system listed in the Council
Regulation (EC) No 440/2008, B.4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. No erythemna or oedema formation was observed at any of the observation timepoints (1, 24, 48, 72 h).
Other effects:
A slight gray staining produced by the test item of the treated skin was observed in the three animals 1 hour after test item exposure.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

60 min

0/0/0

0/0/0 

24 h

 0/0/0

0/0/0 

48 h

 0/0/0

0/0/0 

72 h

0/0/0 

 0/0/0

Average 24h, 48h, 72h

 0

 0

Reversibility*)

 

 

Average time (unit) for reversion

 

 

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation (EC) No 1272/2008 (CLP)
Conclusions:
Beryllium metal powder was not irritant to intact rabbit skin.
Executive summary:

The skin irritation potential of beryllium metal powder was investigated in rabbits according to OECD guideline 404. The test item was applied undiluted to the shorn skin of rabbits and held in contact by means of a semi-occlusive dressing for 4 hours. After exposure, excess material was removed by washing with lukewarm water.

No signs of corrision or skin irritancy (erythema, oedema) was observed at any of the observation timepoints (1, 24, 48 and 72 h after exposure).