Beryllium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-12-12 to 2008-12-24

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS Young Adult New Zealand White, SPF
- Source: Harlan Laboratories, Horst, The Netherlands
- Age at study initiation: 18 weeks (male), 17 weeks (females)
- Weight at study initiation: 2550 g (male), 2223-2455 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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g beryllium metal powder

Duration of treatment / exposure:

test material was not washed out after instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no



SCORING SYSTEM:according to the numerical scoring system listed in the Council
Regulation (EC) No 440/2008, B.5

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: average 7d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Irritant / corrosive response data:

No corrosion of the cornea was observed at any of the reading times.

Other effects:

No staining produced by the test item of the treated eye was observed. Grey test item remnants were evident in all animals at the 1-hour reading. No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Slight to moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted as slight up to 72 hours after treatment. Slight swelling (chemosis) of the conjunctivae was observed in all animals at the 1-hour reading. Slight to moderate reddening of the sclerae was present in all animals 1 hour after treatment and persisted as slight in two animals up to the 24- or 72-hour reading. Slight to moderate ocular discharge was recorded in all animals at the 1-hour reading.
No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals.

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	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	2/1/1	1/1/1
24 h	0/0/0	0/0/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	1/1/1	0/0/0
72 h	0/0/0	0/0/0	1/1/1	0/0/0
Average 24 h, 48 h, 72 h	0	0	1	0
7 days	0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*)			c	c
Average time for reversion			7 d	24 h

 

*) 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: OECD GHS

Conclusions:

Beryllium metal powder was not irritaing to rabbit eyes.

Executive summary:

The eye irritation potential of beryllium metal powder was investigated according to OECD guideline 405. 0.1 g of the unchanged test item were applied into the conjunctival sac of the left eye of three New Zealand White rabbits. The test item was not washed out. The eyes of the animals were observed for signs of irritancy 1, 24, 48 and 72 h after adminitstration. Slight initial swelling was observed after 1 hour, but resolved by 24 hours. Redness of the conjunctivae was observed until 72 h after administration, and thus animals were observed again after 7 days, by when the redness had completely resolved in all animals.