Bis(trimethoxysilylpropyl)amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

use of 6 animals; observation period 7 d; rather occlusive conditions

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(trimethoxysilylpropyl)amine

EC Number:

280-084-5

EC Name:

Bis(trimethoxysilylpropyl)amine

Cas Number:

82985-35-1

Molecular formula:

C12H31NO6Si2

IUPAC Name:

3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane

Details on test material:

- Name of test material (as cited in study report): Organofunctional Silane Y-9492
- Physical state: clear, non-viscous liquid
- Lot/batch No.: 09989
- Identification: NB 2225-99
- BRRC Sample No.: 44-365
- Date of Receipt: 15 December 1981

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3 male and 3 female rabbbits

Details on study design:

TEST SITE
- Type of wrap if used: gauze patch loosely covered with impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing: removal of test substance
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritant / corrosive response data:

In addition to the oedema and erythema scores (see table 1) desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7. Fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In 1 animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points.

Any other information on results incl. tables

Table 1: Individual results of the skin irritation study.

Observation time	Rabbit no.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
5 h	2	1	4	1	4	1	2	1	2	1	1	1
24 h	1	1	2	2	1	1	1	1	1	2	1	2
48 h	2	1	2	2	2	2	1	0	1	2	1	2
72 h	2	1	2	2	2	2	1	0	1	1	1	1
7 d	2	1	2	0	1	0	0	0	1	0	1	0
Mean value 24 + 48 + 72 h	1.66	1	2	2	1.66	1.66	1	0.33	1	1.66	1	1.66

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test item was investigated for skin irritation/corrosion broadly according to the OECD TG 404, but not in compliance with GLP. 0.5 ml of the undiluted test material was occlusively applied to the clipped skin of 3 male and 3 female New Zeeland White rabbits. After 4 h of exposure the test material was removed and the animals were maintained for a 7 day-observation period. The mean erythema and oedema scores were 1.4 each and were not fully reversible until study termination. In addition, desquamation and fissuring was observed. Desquamation was observed in all animals from day 1 to day 7, whereas fissuring was observed after 5 h in all animals and was only present in the females after 24 h. In one animal fissuring was still observed after 7 d. The chemical residue was apparent on the skin in all animals at all time points. The authors concluded the test item to be slightly irritating. Nevertheless, since mean animal scores do not exceed 1.4, the individual scores at 24, 48, and 72 h reading time points never exceeded a score of 2, and individual animal scores throughout the only 7 days lasting observation period give evidence that the effects are transient, classification for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.