Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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).