Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

The skin sensitising potential of Tris-(2-ethylhexyl)amin O 2446 was investigated in a Local Lymphnode Assay conducted according to OECD guideline 429 and GLP regulations by Harlan Cytotest Cell Research GmbH for BASF SE (BASF SE 2010). The substance was dissolved in acetone:olive oil (4+1). In the main experiment, three groups each of four female mice were treated with 5, 10 or 20% (w/v) test item concentration by topical application at the dorsum of each ear on three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised, pooled per animal and immediately weighed. Furthermore, the ears were punched after sacrifice at the apical area using a biopsy punch and were immediately pooled per animal and weighed using an analytical balance. Single cell suspensions of lymph node cells (pooled per group) were prepared and lymphocyte proliferation was quantified by measuring the incorporation of radio-labelled thymidine into the lymph node cells by beta-Scintillation Counting.

The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. Signs of local irritation (e.g. reddening of the ear skin, ear swelling) were also not observed during the study period.

Stimulation Indices (S.I.) of 0.72, 0.84, and 2.91 were determined with the test item at concentrations of 5, 10, and 20% in acetone:olive oil (4+1), respectively. A statistically significant increase in lymph node weights was observed in the group treated with 20% test item concentration in comparison to the vehicle control group (p<0.001), however, this is not considered as biologically relevant as none of the S.I.s determined for the tested concentrations exceeded the threshold of 3. A statistically significant increase in ear weights was also observed in this group in comparison to the vehicle control group (p=0.009) indicating the irritation potential of the test item.

The test item Tris-(2-ethylhexyl)amin O 2446 did not show a skin sensitizing potential in this assay under the conditions of this study.

 


Migrated from Short description of key information:
The test item Tris-(2-ethylhexyl)amin O 2446 did not show a skin sensitizing potential in the LLNA.
- not sensitizing (CBA/CaOlaHsd mice, OECD TG 429)

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no information available on the potential of the substance to produce respiratory sensitisation in animals or humans.


Migrated from Short description of key information:
No data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitisation is not warranted under Directive 67/548/EEC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for sensitisation is not warranted under Regulation (EC) No.1272/2008, as amended for the 2nd time in Commission Regulation (EU) No. 286/2011.