2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)-1,3-propanediol hydrochloride

Endpoint summary

Description of key information

In a GLP-Study according to OECD TG 429 (LLNA), the read-across substance, which was tested up to 25 % in aqueous 1 % Pluronic (limited due to solubility), did not induce any skin sensitisation (reference 7.4.1 -1).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (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 section 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

SI

Value:

1.7

Test group / Remarks:

25 %

Parameter:

SI

Value:

1

Test group / Remarks:

10 %

Parameter:

SI

Value:

0.6

Test group / Remarks:

5 %

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No study data with the test item is available for skin sensitisation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the skin sensitising potential of the test item.

The aim of the study according to OECD 429 was to evaluate the skin sensitization potential of the test item following dermal exposure in the Local Lymph Node Assay. A formulation evaluation and a Dose Range Finding test (DRF) were performed to find an appropriate vehicle and the maximum applicable concentration according to the relevant guidelines. Solubility of the test item in vehicles preferred in the LLNA was evaluated and concentration series of 100 %, 50 %, 25 %, 10 % etc. were used. The maximum attainable concentration (based on solubility) was 25 % (w/v) in aqueous 1 % (w/v) Pluronic®PE 9200 (Plu). According to results of the DRF, where no adverse effect was observed up to this maximum concentration, the test item was examined in the main test as 25 %, 10 % or 5 % (w/v) formulations in the selected vehicle of Plu. Appropriate positive control (α-Hexylcinnamaldehyde, HCA), furthermore two negative control groups dosed with the vehicles of the test and positive control groups, respectively, were employed. The positive control item (25 % (w/v) HCA in Acetone:Olive oil 4:1 (v/v) mixture, AOO) induced significant stimulation over the relevant control (SI = 6.7) thus confirming the validity of the assay. No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group. No significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the relevant control (Plu) was noted for the test item at the applied test concentrations. The observed stimulation index values were 1.7, 1.0 and 0.6 at test item concentrations of 25 %, 10 % and 5 % (w/v), respectively. The response was dose-related, however no statistical significance was observed. Additionally the SI value observed at the highest test concentration (25 %, w/v) was well below the threshold value of 3. As 25 % (w/v) was the maximum soluble concentrations achieved in a range of vehicles no significantly higher absorption of the test item is presumable hence the dose-response relationship was considered not biologically significant. Accordingly, the test item was considered to be not a skin sensitizer. In conclusion, under the conditions of the present assay, the test item tested at the maximum feasible concentration of 25 % (w/v, based on solubility) and also at concentrations of 10 % or 5 % (w/v) as formulations (apparently solutions) in a suitable vehicle (aqueous 1 % (w/v) Pluronic®PE 9200) was shown to have no skin sensitization potential in the Local Lymph Node Assay.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item does not require classification according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.