2-({2-[4-(dimethylamino)benzoyloxy]ethyl}(methyl)amino)ethyl 4-(dimethylamino)benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 August 2006 to 25 August 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24th April, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

466-080-8

EC Name:

-

Molecular formula:

C23H31N3O4

IUPAC Name:

466-080-8

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Name: LFC 2098
Product/common name: LFC 2098
Purpose: Industrial chemical
Colour: white
Physical state: solid, powder
Purity: 99.69%
Storage: at room temperature, protected from light
Molecular formula: C23H3104N3
Molecular weight: 413
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
New Zealand White Rabbits Hsdlf:NZW.
Source: Harlan Winkelmann GmbH, D-33l78 Borchen
3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Weights at study initiation: 2.9, 2.6 and 2.4 kg

ENVIRONMENTAL CONDITIONS
Semi-barrier in an air conditioned room
Temperature: 18 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to ssniff K-H, 4 mm V2333-000 complete diet for rabbits - maintenance, rich in crude fibre, totally pathogen free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Certificates of food, water and bedding are filed at BSL Bioservice
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Adequate acclimatization period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Test item used as provided but moistened with isotonic saline NaCl 0.9% to ensure good contact

Amount / concentration applied:

A dose of 0.5 g of the test item was applied to each test site

Duration of treatment / exposure:

Test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period, residual test item was removed by using tap water.

Observation period:

Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.

Number of animals:

3

Details on study design:

The test item was applied as a single dose to a small area (approx. 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing. Test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period, residual test item was removed by using tap water. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours.
There were no significant body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this irritation study it can be stated that the test item LFC 2098 showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 BBC) the test item LFC 2098 does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

On the basis of the test results and in conformity with the criteria given in Annex VI of the Directive, the substance should be: not classified