Perrhenic acid

Endpoint summary

Description of key information

Perrhenic acid has an extreme pH of 0.7. An in vitro membrane barrier test for skin corrosion (CORROSITEX assay) on perrhenic acid indicated the substance was corrosive, and should be classified as subcategory 1A. Results from skin irritation/corrosion (in vitro and in vivo) and eye irritation/corrosion (in vitro) studies with the related material rhenium (VII) oxide support the assessment that Perrhenic acid is likely to be corrosive to the skin and eyes. Based on overall Weight of Evidence and experience, classification as Skin Corr 1A and Eye Dam 1 is considered appropriate.  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

7 April 2003 – 18 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD Guideline No. 404, EEC Directive 92/69/EEC, US EPA Guideline OPPTS 870.2500 and Japan MAFF Guideline No. 8147.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Also followed Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this is in line with OECD 404.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: New Zealand White A1077 INRA (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: about 5-6 months
- Weight at study initiation: 3.37-3.68 kg
- Housing: 1 rabbit per stainless steel wire mesh cage with a grating floor, area 3000 cm2
- Diet (e.g. ad libitum): Approx. 130 g/animal per day, Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland
- Water: ad libitum tap water
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 6 am – 6 pm light, 6 pm – 6 am darkness

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

other: Solid test substance minimally moistened with a suitable amount of doubly-distilled water to guarantee skin contact.

Controls:

other: Untreated skin sites of the same animals.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of unchanged test substance minimally moistened with doubly-distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): A suitable amount to guarantee skin contact.
- Purity: doubly-distilled

Duration of treatment / exposure:

3 min. In addition, one of the animals was also exposed for 1 hr at a different skin site

Observation period:

Up to 8 days post application

Number of animals:

Four males

Details on study design:

TEST SITE
- Area of exposure:2.5 x 2.5 cm
- Type of wrap if used: Test patch (Idealbinde, Pfalzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece, Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance removed with Lutrol (polyethylenglycol) and Lutrol/water (1:1)
- Time after start of exposure: 3 min and 1 hr

SCORING SYSTEM: The evaluation of skin reactions was performed according to the quoted guidelines. For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation was based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hr after 3 min exposure

Score:

2

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Study discontinued because of severe irritation seen in this animal at the 1-hr exposure site.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hr after 3 min exposure

Score:

0

Max. score:

4

Remarks on result:

other: Study discontinued because of severe irritation seen in this animal at the 1-hr exposure site.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean, up to 72 hr after 3 min exposure

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Scaling reported after 8 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean, up to 8 days after 3 min exposure

Score:

0

Max. score:

4

Remarks on result:

other: Scaling reported after 8 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean, up to 7 days after 3 min exposure

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Parts of the application area whitish discoloured after 24 hr. Eczematoid skin change noted after 7 days. Study discontinued after 7 days because of severe irritation.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean, up to 7 days after 3 min exposure

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Parts of the application area whitish discoloured after 24 hr. Eczematoid skin change noted after 7 days. Study discontinued after 7 days because of severe irritation.

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: Mean, up to 7 days after 3 min exposure

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Parts of the application area whitish discoloured after 24 hr. Eczematoid skin change noted after 7 days. Study discontinued after 7 days because of severe irritation.

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: Mean, up to 7 days after 3 min exposure

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Parts of the application area whitish discoloured after 24 hr. Eczematoid skin change noted after 7 days. Study discontinued after 7 days because of severe irritation.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean, 1 hr after 1 hr exposure

Score:

2

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Index for erythema could not be read because of necrosis immediately following the application period. Study discontinued after 1 hr because of severe irritation.

Irritant / corrosive response data:

Immediately after the exposure period of 3 min, moderate erythema was observed in all of the animals and persisted, in one animal for up to 72 hr. In two animals, it increased in intensity after 48 hr, persisting in one up to day 7 and worsening, again, in the other up to 7 days. Scaling, eczematoid skin changes and whitish discolouration of the application area were noted. Suspected corrosive effects were noted after 1 hr application. The cutaneous reactions in only one animal were reversible within 8 days.

Following the 1 hr exposure period, necrosis was seen immediately after removal of the patch and the index for erythema could not be read. However, the surrounding area of the application site showed moderate erythema and the animals additionally exhibited oedema.

Other effects:

Pathological examination following 1 hr exposure revealed severe thickening at the application site, with histopathological examination showing full thickness necrosis. After the 3 min exposure period, the surface of the application site was encrusted and histopathological examination of the two animals humanely killed at 7 days again showing full thickness necrosis.

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Rhenium (VII)-oxide (0.5 g) produced moderate to severe erythema, slight to moderate oedema and was severely corrosive following semioccluded application to the clipped, intact skin of four male rabbits.

Executive summary:

In a guideline study, rhenium (VII)-oxide (CAS 1314-68-7) (0.5 g) was applied (semioccluded) to the clipped, intact skin of four white male rabbits. After 3 min and, in one animal an additional 1 hr exposure at a different skin site, the dressing was removed, the remaining test material gently washed off and the skin site assessed for erythema and oedema formation. Assessments were again made 1, 24, 48 and 72 hrs after skin application, as well as 7 or 8 days later. Gross and histopathological examination of the skin was also performed. Moderate to severe erythema and slight to moderate oedema were noted and rhenium (VII)-oxide was classified as severely corrosive. Severe thickening at the application site, lesions with crusted surfaces and full thickness necrosis on histopathological examination were also observed. The animal given the 1-hr exposure was humanely killed following removal of the patch due to suspected corrosive effect. Under EU CLP regulations, the test material would be classified in category 1 (corrosive) (with the results suggesting subcategory 1B).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Non GLP study; no lysis time; no data on positive/negative controls

Qualifier:

no guideline available

Principles of method if other than guideline:

Toxicity to chorioallantoic membrane of a chicken egg

GLP compliance:

no

Vehicle:

water

Amount / concentration applied:

undiluted substance and a 10% solution in doubly- distilled water

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

up to 65 seconds

Details on study design:

Undiluted substance applied to one egg and 10% solution applied to 3 eggs. Time (seconds) to appearance of haemorrhagia and coagulation assessed.

Irritant / corrosive response data:

Undiluted substance - haemorrhagia and coagulation after 1 sec
10% solution - haemorrhagia - 22.7 sec (mean) ; coagulation - 58.7 sec (mean)

Interpretation of results:

other: May cause severe eye damage

Remarks:

Criteria used for interpretation of results: not specified

Conclusions:

The test substance may cause severe eye damage.

Executive summary:

The effect of the test substance, rhenium (VII) oxide on chick chorioallantoic membrane in vitro (using the HET-CAM assay) has been examined to assess potential ocular corrosivity/severe irritancy.

Application of the undiluted test substance caused rapid haemorrhage and coagulation (in 1 sec), whereas application of a 10% solution in doubly-distilled water resulted in haemorrhage in between 15 and 35 sec (mean 22.7 sec) and protein coagulation in between 54 and 65 sec (mean 58.7 sec). Because of the absence of vascular lysis data, and irritation score (IS) can not be determined.

This study suggests that rhenium (VII) oxide may cause severe eye damage.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
A good quality guideline study on a relevant material.

Justification for selection of eye irritation endpoint:
Only one (in vitro) study available. Although this is not a guideline study, the result supports the overall conclusion.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive