Mercury

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

1997-02-04 to 1997-02-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, but reliable with restrictions: - The study was conducted with an Ti-Hg, Cu-Sn Zr-Al alloy containing onla about 24.8% mercury. - The type of coverage should be semi-occlusive, but in this study occlusive dressing was used. - The body weight of the rabbits at the start and at the conclusion of the test was not stated. - The stability of the test item was not stated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

, 1992-07-17

Deviations:

yes

Remarks:

, please refer to "Rationale for reliability incl. deficiencies"

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ti-Hg, Cu-Sn Zr-Al alloy

IUPAC Name:

Ti-Hg, Cu-Sn Zr-Al alloy

Details on test material:

- Name of test material (as cited in study report): MISCELA HY-TQS
- Chemical name: Ti-Hg, Cu-Sn Zr-Al alloy
- Chemical structure: N.A.
- Chemical class: alloys
- Physical state: grey powder
- Analytical purity: > 98 %
- Impurities: mainly oxygen
- Composition of test material, percentage of components: Ti 29.2 % - Hg 24.8 % - Cu 14.8 % - Sn 21.2- Zr 8.4 % - Al 1.6 %
- Batch No.: 01-96
- Preparation date: December 1996
- Stability: stable at room temperature
- Storage condition of test material: room temperature in sealed vessel
- Known conditions that could lead to instability: heating above 100 °C may cause release of mercury vapours
No further information on the test material was stated.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Conelli S.n.c., Via Milano, 61 - 28041 ARONA (Novara - Italy) (Shipping slip No. 219, dated October 2, 1996)
- Age at study initiation: 6 - 7 months old
- Housing: in metal cages measuring 62x47.5x38h cm with stainless steel feeders. The cages were hung on metal racks over a stainless feeder. The cages were periodically flushed away by a time-programmed siphon system from above.
- Diet (ad libitum): a diet coded "2 RB 15 GLP Certificate" produced by the Charles River Italia's feed licensee Mucedola S.r.l., Settimo Milanese. The Producer supplemented the diet with vitamins and trace elements.
- Water: filtered water (from municipal water main)
- Acclimation period: animals were clinically observed every day.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 2
- Relative humidity: 50 % +/- 15
- Air changes: 20 air changes per hour (filtered on HEPA 99.97 %)
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article (moistened with 1 ml of tap water, to ensure good contact with the skin) was applied.
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:

One rabbit: 3-minute, 1-hour and 4-hour exposure periods
Two rabbits: 4-hour exposure period

Observation period:

Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in one rabbit and at 1, 24, 48 and 72 hours after the 4-hour exposure period in all rabbits.

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Approximately 24 hours before the test, fur was clipped from the trunk of the animals. Care was taken not to abrade the skin.
- The test article (moistened with 1 ml of tap water, to ensure good contact with the skin) were applied to a small area (approximately 6 cm^2) of skin.
- In the first instance one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. Since no gross skin reactions were noted, the test article was applied for an exposure period of 1 hour on the second site. The application area was covered witha gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). Since no gross reactions were observed after the one-hour exposure period, the test article was applied for an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above.
- The test was completed using two additional animals with a 4-hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was gently removed using water without altering the integrity of the epidermis.
- Time after start of exposure: at the end of each exposure time.

SCORING SYSTEM: Draize scoring system
- Dermal irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.
- Adjacent areas of untreated skin of each animal served as control for the test.

OBSERVATIONS
- Inspections for mortality and general clinical signs were made once a day.
No further information on the study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No changes were seen at any test article application site.

Other effects:

- No mortality was seen during the study.
- No clinical signs, either general or local (at application sites) were noted in any rabbit.

Any other information on results incl. tables

3-minute exposure period in one rabbit: neither erythema nor eschar was observed.

1-hour exposure period in one rabbit: neither erythema nor eschar was observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article MISCELA HY-TQS is considered as non-irritant for the skin.