Beryllium

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Beryllium

EC Number:

231-150-7

EC Name:

Beryllium

Cas Number:

7440-41-7

Molecular formula:

Be

IUPAC Name:

beryllium

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

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).