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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 Nov 1997 - 11 Nov 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997
Reference Type:
secondary source
Title:
EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
Author:
US EPA
Year:
2011
Bibliographic source:
High Production Volume Chemical Challenge Program

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2-(2-butoxyethoxy)ethyl) adipate
EC Number:
205-465-5
EC Name:
Bis(2-(2-butoxyethoxy)ethyl) adipate
Cas Number:
141-17-3
Molecular formula:
C22H42O8
IUPAC Name:
bis(2-(2-butoxyethoxy)ethyl) adipate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Age at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 13 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 4 Nov 1997 to 11 Nov 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days Reading time points: 4.5, 24, 48, and 72 h and 7 days after treatment)
Number of animals:
6 (3 males, 3 females)
Details on study design:
TEST SITE- Area of exposure: approximately 6 cm²- Type of wrap if used: The area was covered with a 2.5 cm² surgical gauze pad (Johnson & Johnson). This was held in place with 3 inch Johnson & Johnson hypo-allergenic cloth tape, semi-occlusively. Animals were collared for the deration of the exposure to preclude access to the siteREMOVAL OF TEST SUBSTANCE- Washing (if done): Remaining test article was gently washed from the skin with water and paper towels.- Time after start of exposure: 4 hSCORING SYSTEM: Each site was then individually examined and scored at 30 and 60 minutes following unwrapping for erythema and edema according to the Draize Scoring System.OTHERThe hair of the mid-dorsal area of the trunk of each animal, between scapulae and pelvis, was shaved using an Oster small animal clipper with surgical head (#40). Care was taken to avoid abrasion of the skin during clipping. Prior to dose application, animals were placed into wooden restrainers.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.72
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: One animal showed accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: revrsibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Other effects:
The animals did not exhibit any abnormal clinical signs for the duration of the study.

Any other information on results incl. tables

Table 1: Primary dermal irritation in rabbits / individual results

Rabbit (number)

4 ½ hr

24 hr

48 hr

72 hr

Day 7

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

1

0

1

0

0

0

-

-

2

1

0

1

0

1

0

1

0

0

0

3

1

0

1

0

1

0

0

0

-

-

4

1

0

1

0

1

0

1

0

0

0

5

1

0

1

0

1

0

1

0

0

0*

6

1

0

0

0

0

0

0

0

-

-

* Accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.

The primary dermal irritation index was 0.65. The animals in this study did not exhibit any abnormal signs for the duration of the study. Under the conditions of this study, the test article elicited minimal irritation.

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
CLP: not classifiedDSD: not classified

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