Aspartic acid, N,N'-(2-methyl-1,5-pentanediyl)bis-, 1,1',4,4'-tetraethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-260-2

EC Name:

-

Cas Number:

168253-59-6

Molecular formula:

C22H40N2O8

IUPAC Name:

1,5-bis[1,2-bis(ethoxycarbonyl)ethylamino]-2-methylpentane

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chr. Fred Leuschner & Co., Löhndorf/Post Wankendorf, Germany
- Sex: males
- Age at study initiation: approx. 6 month
- Weight at study initiation: 2.4 - 2.9 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: at least 20 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The surrounding untreated skin served as a control.

Amount / concentration applied:

500 µl

Duration of treatment / exposure:

4 h

Observation period:

Scores were taken 60 min. after patch removal, and after 24, 48, 72 hours. Skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application.

Number of animals:

3 males

Details on study design:

STUDY DESIGN
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. For the duration of exposure the animals were kept in comfortable restrainers.

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: test site was covered with a gauze patch, which was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- After the 4-hour exposure period the patch was removed.
- Washing (if done): not reported

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2

Time point:

other: 24, 48 and 72 hours

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: mean score: 0.67

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Other effects:

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

In a study according to OECD TG 404 the test item was applied for 4 hours under semiocclusive dressings to the intact shaved skin of 3 male rabbits. Skin irritation was assessed after 1, 24, 48, and 72 hours using the Draize scale. Two rabbits showed a very slight erythema (grade 1) 24 and 48 hours after exposure with full reversibility after 72 hours. No systemic intolerance reactions were observed.