Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Feb - 23 Feb 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
BASF Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium acrylate
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.77 kg (mean)


ENVIRONMENTAL CONDITIONS
no details reported

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no amount specified
- Concentration (if solution): 30 % (20 h exposure), 50 % (1, 5, 15 min, and 20 h exposure)
Duration of treatment / exposure:
1 min, 5 min, 15 min, and 20 h
Observation period:
48 - 72 hrs
Number of animals:
2 animals (1, 5, 15 min); 4 animals (20 h)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data


REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 h)
- Time after start of exposure: 1, 5, and 15 min, respectively


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 hrs
Score:
0.59
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: 20 hrs exp. (50 % aqueous)
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 20 hrs exp. (50 % aqueous)

Any other information on results incl. tables

Mean erythema score after 24, 48 and 72 h:

 

Exposure time

Concentration [%]

24 h

48 h

72 h

mean

 

 

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

1 min

50

0

0

0

0

-*

-*

0

0

5 min

50

0

0

0

0

-*

-*

0

0

15 min

50

0

0

0

0

-*

-*

0

0

20 h

30

0

0

0

0

0

0

0

0

20 h

50

1**

1

0

1

-*

0

0.5

0.67

* The study was discontinued after 48 hrs.

** blotchy

 

 

Mean edema score after 24, 48 and 72 h:

Exposure time

Concentration [%]

24 h

48 h

72 h

mean

 

 

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

1 min

50

0

0

0

0

-*

-*

0

0

5 min

50

0

0

0

0

-*

-*

0

0

15 min

50

0

0

0

0

-*

-*

0

0

20 h

30

0

0

0

0

0

0

0

0

20 h

50

0

0

0

0

-*

0

0

0

* The study was discontinued after 48 hrs.

 

 


 

Findings at test termination:

 

Exposure time

Concentration [%]

Skin findings

 

 

Animal 1

Animal 2

1 min

50

no skin findings

no skin findings

5 min

50

no skin findings

no skin findings

15 min

50

no skin findings

no skin findings

20 h

30

no skin findings

no skin findings

20 h

50

no skin findings

no skin findings

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU