Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
11/15/93 to 11/19/93
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report, equivalent to or similar to guideline study OECD 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occluded
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dec-1-ene, dimers, hydrogenated
EC Number:
500-228-5
EC Name:
Dec-1-ene, dimers, hydrogenated
Cas Number:
68649-11-6
Molecular formula:
C20H42
IUPAC Name:
Hydrogenated dimerization products of 1-decene
Constituent 2
Reference substance name:
1-decene dimer hydrogenated
IUPAC Name:
1-decene dimer hydrogenated
Constituent 3
Reference substance name:
SHF-21
IUPAC Name:
SHF-21
Details on test material:
- Name of test material (as cited in study report): SHF-21
- Physical state: colorless homogeneous liquid
- Expiration date of the lot/batch: 04-01-1997

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. (Denver, PA)
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70-72°C
- Humidity (%): 38-72%

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): 0.5 mL
Duration of treatment / exposure:
1 hour and 4 hour occlusive exposure
Observation period:
1 hour exposure with a 48 hour post dosing corrosion evaluation
4 hour exposure with a 48 hour post dosing corrosion evaluation - also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post dosing according to the Draize method
Clinical observations were recorded at approximately 1 and 4 hours post dosing and daily thereafter
Number of animals:
3 male / 3 female
Details on study design:
TEST SITE
- Area of exposure: 1 sq. inch test site on right anterior and right posterior flank of each animal
- Type of wrap if used: Webril patch secured with an occlusive rubber dam followed by a nonirritating surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was wiped from the test site with cotton dampened with saline
- Time after start of exposure: after 1 hour and 4 hour exposure

SCORING SYSTEM: irritation according to the Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritant / corrosive response data:
Corrosion was not noted on either the 1 or 4 hour occluded test sites
Other effects:
The following clinical observations were noted in one or more animals: soft stool

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test material is noncorrosive and nonirritant. These findings do not warrant classification of the test material as a skin irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Dermal irritation was evaluated in six New Zealand White Rabbits. The mean erythema and edema scores were 0.The test material was determined to be both Noncorrosive according to the DOT Corrosion Guideline (both 60 Min and 4 Hr occlusion) and Nonirritating according to the EEC and the OSHA PII Guidelines (both 4 Hr Occluded). These findings do not warrant classification of the test material as a skin irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.