Arsenic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 04 to March 06, 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted similarly to OECD guideline 404 with only minor deviations: observation not done immediately following removal of the test substance, no data on purity and bodyweights not followed.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

observation not done immediately following removal of the test substance. No data on purity and bodyweights not followed

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

observation not done immediately following removal of the test substance. No data on purity and bodyweights not followed

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Arsenic acid

EC Number:

231-901-9

EC Name:

Arsenic acid

Cas Number:

7778-39-4

Molecular formula:

H3AsO4

IUPAC Name:

arsoric acid

Details on test material:

- Name of test material (as cited in study report): Desiccant L-10
- Source: Pennwalt Corporation, USA
- Physical state: Light blue, clear liquid
- Date of receipt: January 4, 1985
- Lot/batch No.: 8158
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton-Dutchland, Inc., Denver, USA
- Age at study initiation: Young adults
- Housing: Individually housed in suspended, stainless steel cages
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina #5326), ad libitum
- Water (e.g. ad libitum): Municipal water supply (Elizabethtown Water Co.), ad libitum
- Acclimation period: 29 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-70 °F
- Humidity (%): 30-70%
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light

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 (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

24 hours

Number of animals:

Six (3 males, 3 females)

Details on study design:

TEST SITE
- Area of exposure: Dorsal surface (scapular to lumbar region)
- Type of wrap if used: Test material (0.5 mL) was applied beneath a surgical gauze (1” X 1”), placed directly on the test sites and then secured in position with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were not washed but wiped free of excess test material
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

other: 30 min.

Score:

3.16

Max. score:

4

Reversibility:

other: animals died within 24 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

other: 30 min.

Score:

3.16

Max. score:

4

Reversibility:

other: all animals died within 24 hours

Irritant / corrosive response data:

- Three animals exhibited tissue destruction (necrosis) at the application site at 4.5 hours post-exposure (30 min. after removal of wrappings); the other three animals exhibited moderate to severe erythema and edema.

Other effects:

- Mortality and clinical signs of toxicity: All six animals were found dead within 24 hours after dosing. No unusual antemortem signs were noted.
- Necropsy: Red fluid in the gall bladders of 4/6 animals and clear fluid in the abdominal cavity of one animal; other observations appeared to represent postmortem autolytic changes (discoloration), antemortem stress (brown foci in stomach walls, testes in body cavity) or normal physiological changes

Any other information on results incl. tables

Table 1: Individual dermal irritation score at 4.5 hours post-exposure

 

	Animal No. 1	Animal No. 2	Animal No. 3	Animal No. 4	Animal No. 5	Animal No. 6
Erythema	4	4	3	2	2	4
Edema	3	3	4	3	4	2

Applicant's summary and conclusion

Interpretation of results:

Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, arsenic acid is classified as corrosive to the skin, ‘R34 Causes burns’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘ Category 1: Corrosive 1C’ in CLP Regulation (EC) No. 1272/2008.

Executive summary:

In a primary dermal irritation study performed similarly to OECD guideline 404 and in compliance with GLP, six (3/sex) New-Zealand White rabbits were dermally exposed to 0.5 mL of undiluted Desiccant L-10 (arsenic acid), under a semi-occlusive bandage for 4 hours to clipped skin of the dorsal surface (scapular to lumbar region). Animals were then observed for 24 hours. Irritation was scored by the method of Draize (1959).

 

Three of the six animals exhibited tissue destruction (necrosis) at the application site at 4.5 hours post-exposure (30 min. after removal of wrappings); the other three animals exhibited moderate to severe erythema and edema. All six animals were found dead within 24 hours after dosing. In this study, arsenic acid was found to be corrosive when applied topically to the rabbit. 

 

Under the test conditions, arsenic acid is classified as corrosive to the skin, ‘R34 Causes burns’ according to the criteria of Annex VI of the Directive 67/548/EEC and ‘ Category 1: Corrosive 1C’ in CLP Regulation (EC) No. 1272/2008.

This study is acceptable and satisfies the guideline requirement for an acute dermal irritation study (OECD 404).