Aspartic acid, N-[3-(trimethoxysilyl)propyl]-, 1,4-diethyl 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:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

diethyl N-[3-(trimethoxysilyl)propyl]aspartate

EC Number:

606-274-3

Cas Number:

192389-48-3

Molecular formula:

C14H29NO7Si

IUPAC Name:

diethyl N-[3-(trimethoxysilyl)propyl]aspartate

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 4.5-5 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the surrounding untreated skin served as control

Amount / concentration applied:

Amount: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours as well as 4 to 6 days after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: no residual test item had to be removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: mean score after 72 hours: 1.0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0 - 1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: mean score after 72 hours: 0.33

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Results 4

Irritation parameter:

edema score

Basis:

animal: #1,2,3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Other effects:

No systemic intolerance reactions were observed.

Any other information on results incl. tables

Table 1: Summary of irritant effects on the skin (Exposure: 4 hours)

Observation time  (after patch removal)	1 h	24 h	48 h	72 h	day 4	day 5	day 6
Animal 1
Erythema (redness)  and eschar formation	0	1	1	1	1	1	0
Oedema formation	0	0	0	0	0	0	0
Animal 2
Erythema (redness)  and eschar formation	0	1	0	0	-	-	-
Oedema formation	0	0	0	0	-	-	-
Animal 3
Erythema (redness)  and eschar formation	0	0	0	0	-	-	-
Oedema formation	0	0	0	0	-	-	-

  0 = no pathological findings; - = no examination

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Classification: not irritating

Executive summary:

In a dermal irritation study according to OECD TG 404 KURG 101 was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 male rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours as well as after 4 to 6 days using the Draize scale. The mean irritation index for erythema was 0.44 of max. 4 (0.0-1.0), the mean irritation index for edema was 0.0 of max. 4. Signs were fully reversible in all animals within 6 days. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the skin".