1,2-Ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-06-01 to 2017-07-2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

28 July 2015

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test material

Test material information

Constituent 1

Reference substance name:

(2-aminoethyl)[(4-ethenylphenyl)methyl][3-(trimethoxysilyl)propyl]azanium (2-azaniumylethyl)[3-(trimethoxysilyl)propyl]amine 11-(4-ethenylphenyl)-10-[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-7,10-bis[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-7-[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium hexachloride

EC Number:

605-620-0

Cas Number:

171869-89-9

Molecular formula:

Not applicable to UVCB

IUPAC Name:

(2-aminoethyl)[(4-ethenylphenyl)methyl][3-(trimethoxysilyl)propyl]azanium (2-azaniumylethyl)[3-(trimethoxysilyl)propyl]amine 11-(4-ethenylphenyl)-10-[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-7,10-bis[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium 11-(4-ethenylphenyl)-7-[(4-ethenylphenyl)methyl]-3,3-dimethoxy-2-oxa-7,10-diaza-3-silaundecan-7-ium hexachloride

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 20-21 weeks
- Weight at study initiation: > 3.9 kg
- Housing: ABS-plastic or Noryl rabbit cages; not reported how many animals housed per cage
- Diet: Altromin 2123 maintenance diet for rabbits provided ad libitum
- Water: Municipal drinking water provided ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

In an initial test, one animal was exposed to the test material for 3 minutes, 1 hour, and 4 hours without any reactions being observed. For the experiment, the second animal was exposed to the test material for 4 hours.

Observation period:

72 hours initially; the observation period was extended for animal no. 1 to 6 days and 5 days for animal no. 2 in order to evaluate the reversibility of lesions

Number of animals:

2 males

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk (6 cm2)

- Type of wrap if used: treatment area covered with gauze patch and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: Test material was removed by using cottonseed oil for animal no. 1; there was no residual test material to be removed from animal no. 2.
- Time after start of exposure: at the end of the exposure period for animal no. 1

OBSERVATION TIME POINTS
0 hr, 1 hr, 24 hr, 48 hr, 72 hr, day 4, day 5, day 6

SCORING SYSTEM:
Erythema and eschar formation: no erythema = 0; very slight erythema = 1; well defined erythema = 2; moderate to severe erythema = 3; severe erythema to eschar formation preventing grading of erythema = 4
Edema formation: no edema = 0; very slight edema = 1; slight edema = 2; moderate edema = 3; severe edema = 4

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

There were no significant effects on body weight.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.

Conclusions:

In an in vivo skin irritation study according to OECD guideline 404 and in compliance with GLP, the mean (24-72 hours) erythema score observed in 2 animals was 1; the mean (24-72 hours) edema score for the same animals was 0. All irritation was reversible within 6 days. Therefore, the test item should not be classified as an irritant.