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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:
76 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive patch used in testing
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
The animals were shaved on the day prior to test substance administration. One 1 square inch test site was selected on the right anterior flank and one 1 square inch test site on the right posterior flank of each animal. The sites were designated as anterior (1-hour occlusion) test site and posterior (4- hour, occlusion) test site. 0.5 ml of the test substance was applied to the posterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a non- irritating surgical tape. 0.5 ml of the test substance was applied to the anterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a nonirritating surgical tape. Elizabethan style collars were fitted to each animal after administration of the test substance.
Following a 1 hour exposure the anterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing.
Following a 4 hour exposure the posterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing. The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method. The collars were removed after the 24 hour ocular evaluation. Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter. The condition of each animal (live, dead, moribund) was checked at least once daily in the morning.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
416-740-6
EC Name:
-
Molecular formula:
Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)
IUPAC Name:
Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich
Details on test material:
The test substance is a colorless homogeneous liquid. This material as stated in the Product Physical And
Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three male and three female young adult New Zealand White rabbits obtained from Hazieton Research Products, Inc. (Denver, PA.) were used in this study. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 70-72° F with a relative humidity of 44-61%.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
1 hour or 4 hours
Observation period:
1, 4.5, 28, 52, and 76 hours post treatment
Number of animals:
3 male and 3 female
Details on study design:
The animals were shaved on the day prior to test substance administration. One 1 square inch test site was selected on the right anterior flank and one 1 square inch test site on the right posterior flank of each animal. The sites were designated as anterior (1-hour occlusion) test site and posterior (4- hour, occlusion) test site. 0.5 ml of the test substance was applied to the posterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a non- irritating surgical tape. 0.5 ml of the test substance was applied to the anterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a nonirritating surgical tape. Elizabethan style collars were fitted to each animal after administration of the test substance.
Following a 1 hour exposure the anterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing.
Following a 4 hour exposure the posterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing. The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method. The collars were removed after the 24 hour ocular evaluation. Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter. The condition of each animal (live, dead, moribund) was checked at least once daily in the morning.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 52 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4.5 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4.5 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4.5 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 4.5 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 4.5
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 4.5 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 28 hours
Remarks on result:
other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The erythema and edema scores for 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich are less than 2.3. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich as an 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:

Three male and three female New Zealand white rabbits were treated with 0.5 mL of 1,4 -Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich for 1 or 4 hours to assess skin irritation and corrosion. Clinical observations were made at 4.5, 28, 52, and 76 hours post exposure. Slight erythema (mean Draize score of 1) and edema (mean Draize score of 0.2) were observed at 4.5 hours, but at completely reversed by 52 hours. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich 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.