Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(1984)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Molecular formula:

Not applicable

IUPAC Name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: males: 303-345 g, females: 213-239 g
- Housing: The animals were housed under standard laboratory conditions. The animals were individually housed in labelled poly carbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands). Certificates of sawdust analysis were examined and then retained in the RCC NOTOX archives. The animals were identified by earmarks.
- Diet (ad libitum): standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland). Certificates of analysis were examined and then retained in the RCC NOTOX archives.
- Water (ad libitum): tap-water. Certificates of analysis (performed quaterly) were examined and then retained in the RCC NOTOX archives.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 55 (fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

paraffin oil

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of the animal, males approximately 25 cm² (5 x 5 cm) and females approximately 18 cm² (3.5 x 5 cm)
- Type of wrap if used: gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, St. Paul ,USA), with drops of petrolatum

REMOVAL OF TEST SUBSTANCE
- Washing: with a tissue moitured with tap-water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 10 ml/kg bw
- Constant volume or concentration used: yes

VEHICLE
- Specific gravity: approximately 0.8
- Pretreatment: flushing with nitrogen and dehydration by the use of activated grains of molecular sieve (0.3 nm)

DOSAGE PREPARATION
The prepared test substance was used within 24 hours after preparation and the formulation was prepared within 1 hour prior to dosing. The test substance was weighed into a dry glass flask on an analytical balance and the vehicle (w/w) was added. Adjustment was made for specific gravity of the vehicle. No flushing of the glass flask occured before and after preparation of the formulation. Homogeneity of the test substance was obtained by shaking.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations (mortality/viability): twice daily
- Frequency of weighing: days 1 (pre-administration), 8, and 15
- Frequency of observations (clinical signs): at periodic intervals on the day of dosing (day 1) and once daily thereafter. The time of onset, degree, and duration were recorded.
- Frequency of observations (skin irritation): daily, following bandage removal. The time of onset, degree, and duration were recorded.
- Necropsy of survivors performed: yes (sacrifice by oxygen/carbon dioxide asphyxiation)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: - Lethargy was noted in one animal on day 1. - Erythema was noted in 4 females during the observation period.

Gross pathology:

Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test item was tested for acute dermal toxicity according to the OECD TG 402 (1987) and in compliance with GLP. No mortality occured and the LD50 was determined to be > 2000 mg/kg bw for both male and female rats. Hence, classification according to EC/1272/2008 is not warranted.