Bis(2-(2-butoxyethoxy)ethyl) adipate

Skin irritation / corrosion

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Reference 2

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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.

Results 2

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

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

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

Results 5

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: revrsibility: not applicable

Results 8

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