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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:
December 1979
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:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: CFR 1500.41 - Method of testing primary irritant substances.
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
Observation period lasted 72 hours.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-sec-butyl-2,6-di-tert-butylphenol
EC Number:
241-533-0
EC Name:
4-sec-butyl-2,6-di-tert-butylphenol
Cas Number:
17540-75-9
Molecular formula:
C18H30O
IUPAC Name:
4-(butan-2-yl)-2,6-di-tert-butylphenol
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
According to DHEW standards in a USDA registered, AAALAC accredited facility.

- Source: Isaacs Lab Stock
- Age at study initiation: Not specified
- Weight at study initiation: at least 2.0 kg.
- Housing: Cages
- Diet: Not specified
- Water: Not specified
- Acclimation period: A minimum of 7 days

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount applied per test site: 0.5 mL
Duration of treatment / exposure:
Single application.
Observation period:
72 hours
Number of animals:
6 animals per test group.
Details on study design:
Study Design:

The hair on the back of healthy appearing animals was clipped prior to administrationg using a small animal clipper, the leftside of each rabbit was abraded while the right side was left intact.
0.5 mL of test solution was drawn up in a 1 cc sterile syringe and put under a 2,5 x 2,5 cm two ply sqaure gauze patch which was placed on the test sites. dermicel tape was placed around the border of the patch. Dental dam was wrapped around the back and held in place by several wrappings of Elastoplast tape. The rabbits were put in Newmann harnesses and returned to their cages for 24 hours. After the 24 hour exposure the harnesses and wrappings were removed.

Observations:
obersevations of erythema and edema at 24 hours and 72 hours post treatment intact and abraded.

SCORING SYSTEM: according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
As the irritation was not fully reversible within 72 hours, the test substance is considered to be irritant.

Any other information on results incl. tables

The abraded skin had a similar response to the test substance as the intact skin.

See Illustration- Overall remarks,

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
An acute skin irritation study with XC-132 on rabbits was performed similar to OCED 404 guidance. A single occlusive application of XC-132 to rabbit skin for 24 hours elicited redness to the skin. No reversibility was shown after 72 hours. Therefore, XC-132 is classified for skin irritation according to GHS and CLP criteria.
Executive summary:

In an skin irritation study with rabbits, performed according FHSA procedures (CFR 1500.41), similar to OECD 404 0.5 mL of test solution under a 2,5 x 2,5 cm two ply sqaure gauze patch was applied on clipped skin and occlusivly covered with a Newmann harnesses for 24 hours. XC-132 elicited redness to the skin after 24 hours with no sign of reversibility after 72 hours. Based on the results, the substance is classified for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).