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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 Oct. 1978 - 31 Okt. 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: 24 hours exposure period
Principles of method if other than guideline:
The test method was essentially that of Draize et al:
Draize, John H., Woodward, Geoffrey, and Calvery, Herbert O., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. & Ex. Ther. 82, 377, (1944).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, C12-15-alkyl esters
EC Number:
270-112-4
EC Name:
Benzoic acid, C12-15-alkyl esters
Cas Number:
68411-27-8
Molecular formula:
C19-22 H30-36 O2
IUPAC Name:
Benzoic acid, C12-15-alkyl esters

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey, USA
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation period: conditioned prior to use

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped areas of intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours (The wrapping and test material were removed 24 hours following application)
Observation period:
24 and 72 hours following application
Number of animals:
6 (mixed sex)
Details on study design:
TEST SITE
- Area of exposure: trunk, test material application under 2" x " gauze
- Type of wrap if used: (2" x " gauze, covered by adhesive tape) and the entire trunk of each animal was covered with an impermeable occlusive wrapping

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours following application

SCORING SYSTEM: according to Draize scale (erythema formation 0-4, edema formation 0-4, total possible primary irritation score = 8)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: 1 to 6
Time point:
other: 24 h and 72 h
Score:
0.08
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Primary Irritation Index: 0.08
The test material is not a primary dermal irritant to rabbits under the conditions of this test.

Any other information on results incl. tables

Summary of Scores for Skin Irritation: 

Rabbit

Hours:

24

72

Number

Skin

E1

Ed

E

Ed

1

NA2

A3

0

0

0

0

0

0

0

0

2

NA

A

0

1

0

0

0

0

0

0

3

NA

A

0

0

0

0

0

0

0

0

4

NA

A

0

1

0

0

0

0

0

0

5

NA

A

0

0

0

0

0

0

0

0

6

NA

A

0

0

0

0

0

0

0

0

Average

NA

A

0.0

0.3

0.0

0.0

0.0

0.0

0.0

0.0

Combined Averages:     0.3

Primary Irritation Index:   0.08  

1E/Ed = Erythema and Edema

2NA   = Non-abraded skin

3A     = Abraded skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Primary Irritation Index: 0.08
The test material is not a primary dermal irritant to rabbits under the conditions of this test.
Executive summary:

Six albino New Zealand rabbits, mixed sex, were used in a Primary Dermal Irritation study according to the method of Draize et al.

0.5 ml of the test material, as received, was applied to clipped areas of intact and abraded skin. Applications were made under occlusive patches. The wrapping and test material were removed 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hour gradings were averaged to determine final irritation indices.

As the result the Primary Irritation Index was 0.08. Under the conditions of the test the test material is not a primary dermal irritant.