Acrylic acid

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:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acrylic acid

EC Number:

201-177-9

EC Name:

Acrylic acid

Cas Number:

79-10-7

Molecular formula:

C3H4O2

IUPAC Name:

prop-2-enoic acid

Specific details on test material used for the study:

- Name of test material (as cited in study report): acrylic acid glacial.
- Analytical purity: 99.8% pure (determined by GC)
- Lot/batch No.: Tank 8

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr . K . Thomae GmbH, Biberach, FRG (animals 01, 02, 03 ), Boehringer Ingelheim Pharma KG (animals 04, 05)
- Age at study initiation: Young adult animals
- Housing: Single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland.
- Water (e.g. ad libitum): Tap water
- Acclimation period: Acclimatization for at least 1 week .

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

3 minute(s)

Observation period:

1 h and 14 d

Number of animals:

5

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back or flanks.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol(R)** and Lutrol(R)/water (1 :1) .
- Time after start of exposure: 3 min.


** Lutrol(R) E 400 = Polyethylenglycol DAB, BASF AG

SCORING SYSTEM: OECD TG 404 was used.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Other effects:

Tests with animals 01 and 03 were discontinued because of severe irritation. The finding was assessed by macroscopic pathology indicating superficial necrosis and slight edema (animal 03) and discolouration of the application area (animal 01).
Gross- and histopathological examination of the skin of animal 02 was not performed.

Histopathological examination :
Animal 01 : Left flank : Severe swelling of collagen fibres in dermis and subcutis and pyknoses in the basal cell layer
Animal 03 : Left flank : Epidermal coagulation necrosis with edematous swelling of the dermis (no full thickness necrosis)
Animal 04 and 05 : Left flank : Focal deep necrosis (full thickness necrosis), loss of the epidermal adnexa in necrosis area, perifocal moderate epithelial hyperplasia , diffuse inflammatory reaction (corium to subcutis) in the application area.

Any other information on results incl. tables

Table 1: Results

Animal	Reading	Erythema	Edema	Comment
01	1h	-	2	-
02	1h	2	3	Erythema and Edema extending beyond the area of exposure
03	1h	-	3	­
04	1h	3	3	Erythema and Edema extending beyond the area of exposure
05	1h	3	3	Erythema and Edema extending beyond the area of exposure

Under the test conditions chosen and considering the described findings Acrylic acid glacial gives indication of causing full thickness destruction of skin tissue as a result of an exposure period of 3 minutes, when observation period is extended to 14 days, but not within an observation period of 1 hour .

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria