Germanium tetrachloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Germanium tetrachloride

EC Number:

233-116-7

EC Name:

Germanium tetrachloride

Cas Number:

10038-98-9

Molecular formula:

Cl4Ge

IUPAC Name:

germanium tetrachloride

Details on test material:

- Name of test material (as cited in study report): Germanium Tetrachloride
- Molecular formula: GeCl4
- Physical state: liquid
- Analytical purity: >99.99%
- Impurities (identity and concentrations):
- Lot/batch No.: not indicated by the sponsor
- Stability under test conditions: stable, under storage conditions
- Storage condition of test material: room temperature in the dark
- Safety precautions: gloves, goggles and face mask were considered sufficient to ensure personnel health and safety

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute , Someren, The Netherlands
- Age at study initiation: ~14 weeks old
- Weight at study initiation: 2403-2498 g
- Housing: Rabbits were individually housed in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen/ The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden/ The Netherlands) approx. 100 gram per day
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: at least 5 days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5ml

Duration of treatment / exposure:

3 minutes and 1 hour

Observation period:

1h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 4 sites of approximately 6 cm² on a flank of the shaved intact skin
- Type of wrap if used: for each animal 4 strips of micropore tape with each 2 patches, 1 with and 1 without test substance were prepared.

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period, residual test substance was removed using a tissue moistened with tapwater.
- Time after start of exposure: duration of exposure was 3 minutes for 2 patches (1 with and 1 without test substance) and 1 hour for the second 2 patches (1 with and 1 without test substance)

SCORING SYSTEM:

The skin reactions aftr the 3 min exposure were assessed at approximately 60 min after patch removal and the skin reaction after 1 hour exposure were assessed immediately after patch removal

SCORING SYSTEM OF ERYTHEMA AND OEDEMA FORMATION

Erythema and eschar formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Maximum possible erythema score: 4

Oedema formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of it will be well defined
by definite raising) 2
Moderate oedema (raised appr. 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

Maximum possible oedema score: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 60 minutes after 3 min of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 0 minutes after 1 hour of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 60 minutes after 3 min of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 0 minutes after 1 hour of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 60 minutes after 3 minutes of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 0 minutes after 1 hour of exposure

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Irritation: the observed skin irritation consisted of severe erythema and grey discolouration of the treated skin, indicating necrosis. The exposed area fissured and detached from the surrounding skin in all animals
Corrosion: since full tickness destruction of the skin was observed, Germanium tetrachloride should be considered corrosive. These corrosive effects resulted after the 1 hour and 3 minutes applications

Other effects:

TOXICITY SYMPTOMS/MORTALITY :
No symptoms of systematic toxicity were observed in the animals during the test period and no mortality occurred

Any other information on results incl. tables

SCORING OF ERYTHEMA FORMATION

 

Animal no. 2485

 

Duration of exposure	Time after exposure	Erythema	Oedema	Comments
3 minutes	60 minutes	4	-	Exposed area grey coloured. The exposed area fissured and detached from the surrounding area
1 hour	0 minutes	4	-	The exposed area fissured and detached from the surrounding area

 

Animal no. 2486

Duration of exposure	Time after exposure	Erythema	Oedema	Comments
3 minutes	60 minutes	4	-	Exposed area grey coloured. The exposed area fissured and detached from the surrounding area
1 hour	0 minutes	4	-	75% of the exposed area grey coloured. The exposed area fissured and detached from the surrounding area

 

Animal no. 2487

Duration of exposure	Time after exposure	Erythema	Oedema	Comments
3 minutes	60 minutes	4	-	Exposed area grey coloured. The exposed area fissured and detached from the surrounding area
1 hour	0 minutes	4	-	40% of the exposed area grey coloured. The exposed area fissured and detached from the surrounding area

 

Note : Oedema could not be stored due to eschar formation

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Conclusions:

Since full thickness destruction of the skin was observed, Germanium Tetrachloride should be considered corrosive. These corrosive effects resulted after the 3 minutes and 1 hour applications. The skin reactions were assessed at 1 hour oberservation period.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, germanium tetrachloride does require classification as a skin corrosion Cat1A

 

Executive summary:

An acute skin irritation study was performed with Germanium Tetrachloride in New Zealand White rabbits. Parameters monitored during this study included mortality, toxicity symptoms. The irritancy of the test item was evaluated according to the OECD No.: 404, 1981 and EU method B.4 (Acute toxicity Dermal Irritation/Corrosion).

The observed skin irritation consisted of severe erythema and grey discolouration of the treated skin, indicating necrosis. The exposed areas fissured and detached from the surrounding skin in all animals. Since full thickness destruction of the skin was observed, Germanium Tetrachloride should be considered corrosive. These corrosive effects resulted after the 3 minutes and 1 hour applications.