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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 hour exposure followed by a 72 hour observation period
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restriction; study conducted according to OECD Guideline 404 and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
There was one deviation: the test substance characterization was not performed according to GLPs. This deviation did not impact the quality or integrity of the study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Test substance (name as cited in study report): Eastman TXIB
-Source of test material: Eastman Chemical Co.
-Purity: >98%
-Production date: 4/26/2007
-Date of receipt: 7/26/07
-Stability: 1 year
-Storage: Room temperature and humidity
-Description: Clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Test animals:
-Strain: New Zealand White Rabbits (Millbrook Breeding Labs, Amherst, MA)
-Date of receipt: 8/08/07
-Age: 3 months
-Sex: 2 males and 1 female
-Body weight: 2.2-2.5 kg
-Acclimation period: 5 days
-Identification: uniquely numbered metal ear tag

Environmental Conditions:
-Housing: 1 rabbit per suspended wire cage (bedding placed beneath the cage changed at least 3 times weekly)
-Feed: Fresh PMI Rabbit Chow (Diet 5321) provided daily
-Water: available ad libitum
-Light cycle: 12:12 light:dark

In Life Dates:
-Study Initiation: 8/14/07
-Study Termination: 8/17/07

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after patch removal
Number of animals:
3 animals (2 males and 1 female)
Details on study design:
The day before test substance application, the dorsal area of the trunk was clipped of hair, area approximately 10 X 10 cm. The test substance was dosed at a volume of 0.5 mL and a semiocclusive patch was secured over the patch area with non-irritating tape. After 4 hours, the patch was removed, residual test material was removed from the site by gently washing with distilled water, and animals were observed at fixed time points for irritation according to the numerical Draize technique. Body weights were determined before test substance administration and at study termination. Animals were sacrified but no gross pathology was performed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no erythema or edema observed at any time during the study period. The test substance was determined not to be a dermal irritant.
Other effects:
There were no abnormal physical signs during the observation period. All body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2,2,4-Trimethyl-1,3-pentanediol diisobutyrate is not classified as a primary skin irritant. No acute toxicity, erythema or edema was observed after a 4-hour dermal exposure to New Zealand White Rabbits under the occlusive conditions used in this study.

Based on an absence of erythema and edema in New Zealand White rabbits following application to intact skin for 4 hours, 2,2,4-trimethyl-1,3-pentanediol diisobutyrate is not classifiable for Skin Irritation/Corrosion according to GHS. Based on an absence of observable systemic effects, the test material is also not classified for Specific Target Organ Toxicity-single exposure.
Executive summary:

In a skin irritation/corrosion study, 3 New Zealand White Rabbits were exposed to 0.5 mL of the neat test substance, 2,2,4-trimethyl-1,3-pentanediol diisobutyrate, under semiocclusion for 4 hours. The site of application was examined at 1, 24, 48 and 72 hours after patch removal. No signs of irritation were noted during the study. Based on the results of this study, 2,2,4-trimethyl-1,3-pentanediol diisobutyrate presents a low toxicity hazard and is not considered an irritant or corrosive.