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Diss Factsheets

Administrative data

Description of key information

OECD 406 (GPMT): sensitising (intradermal induction with 0.1% test substance preparation) (RA from N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)
OECD 406 (GPMT): sensitising (intradermal induction with 0.5% test substance preparation) (RA from N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)
OECD 429 (LLNA): sensitising (RA from N-(3-(trimethoxysilyl)propyl)ethylenediamine, CAS 1760-24-3)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
intradermal induction 0.1% (v/v); challenge 10% (v/v)
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: CAS 1760-24-3, Hazleton France, 1992
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
intradermal induction 0%; challenge 10% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: CAS 1760-24-3, Hazleton France, 1992
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
intradermal induction 0.1% (v/v); challenge 10% (v/v)
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: CAS 1760-24-3, Hazleton France, 1992
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
intradermal induction 0%; challenge 10% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: CAS 1760-24-3, Hazleton France, 1992
Group:
positive control
Remarks on result:
not measured/tested

Two further in vivo skin sensitisation studies are available for the source substance CAS 1760 -24 -3:

SafePharm Laboratories Ltd., 1987: GPMT

intradermal indution: 0.5%, topical induction: 100%, topical challenge: 100%

1st reading at 24 hours: test group: 20/20 positive reactions

1st reading at 48 hours: test group: 19/20 positive reactions

1st and 2nd reading at 24 and 48 hours, respectively: control group: 0/20 positive reactions

BSL Bioservice, 2005: LLNA

tested concentrations: 5, 10, 25 and 50%

EC3 = 13%

Interpretation of results:
other: CLP/EU GHS Category 1A (H317) according to Regulation (EC) No 1272/2008
Conclusions:
In two guinea pig maximisation study conducted to OECD 406 and to GLP the source substance N-(3-(trimethoxysilyl)propyl)ethylenediamine provoked a positive reaction in 30% and 100% of the test animals. Hence, the source substance is considered to be a skin sensitiser. This result is also supported by an LLNA test. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin sensitisation potential.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No data are available to assess the skin sensitisation potential of N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine (CAS 35141-30-1). Therefore, the risk assessment was performed based on the available data from the source substance N-(3-trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]-ethylenediamine (CAS 35141-30-1). Further details are provided in the analogue justification attached to the respective target entry.

There are three good quality skin sensitisation studies with the source substance, all of which give clear positive results.

The key study is a guinea pig maximisation test, conducted according to OECD 406 and in compliance with GLP. Animals were intradermally induced with 0.1% test substance solution and epicutaneously induced with 10% test substance solution. Challenge exposure was conducted with 10% test substance formulation and provoked a positive reaction in 30% of the test animals, concluding the test substance to be a strong skin sensitiser (Cat 1A according to Regulation (EC) No 1272/2008) (Hazleton France, 1992). 

Two supporting studies are in accordance with the findings of the key study. The first study, also a guinea pig maximisation test, was conducted according to OECD 406 and in compliance with GLP. Animals were intradermally induced with 0.5% test substance solution and epicutaneously induced with undiluted test substance. Challenge exposure was conducted with neat test substance and provoked a positive reaction in 100% of the test animals, concluding the test substance to be a strong skin sensitiser (Cat 1A according to Regulation (EC) No 1272/2008) under the conditions of this test (SafePharm Laboratories Ltd, 1987).

A second supporting study employed a mouse Local Lymph Node Assay, conducted according to OECD 429 and in compliance with GLP. The stimulation indices for 5, 10, 25 and 50% test substance (in 3+1 (v/v) acetone/olive oil) were 1.7, 2.5, 4.7 and 7.9, respectively. The negative and positive (P-Phenylenediamine) controls gave stimulation indices of 1.0 and 12.1, respectively. Based on these results, the EC3 value was calculated at a concentration of 13% of the test substance. The test substance was therefore a sensitiser (Cat 1B according to Regulation (EC) No 1272/2008) under the conditions of this test (BSL BIOSERVICE Scientific Laboratories GmbH, 2005).

The most recent guinea pig maximisation test was selected as key study since the mouse Local Lymph Node Assay has not been generally accepted as suitable for alkoxysilanes due to the likelihood of false positive results (Basketteret al., 2009). However, in this case it was in concordance with the clear evidence for sensitising potential of the registered substance.

Basketter D, Ball N, Cagen S, Carillo JC, Certa H, Eigler D, Garcia C, Esch H, Graham C, Haux C, Kreiling R, Mehling A (2009a). Application of weight of evidence approach to assessing discordant sensitisation datasets: implication for REACH. Reg. Toxicol. Pharmacol.,55, 90-96.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on reliable data from the analogue substance N-(3 -(trimethoxysilyl)propyl)ethylenediamine (CAS 1760 -24 -3), the registered substance N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine(CAS 35141-30-1) is classified as 'Skin Sens. 1A with the hazard statement 'H317: May cause an allergic skin reaction' according to Regulation (EC) No 1272/2008.