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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 (volume or weight with unit): 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h (mean)
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24-48-72 h (mean)
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24-48-72 h (mean)
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h (mean)
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-48-72 h (mean)
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24-48-72 h (mean)
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

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
Conclusions:
Classification: highly corrosive (causes severe burns)