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Diss Factsheets

Administrative data

Description of key information

LLNA: sensitising (based on read-across)

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:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 2008, 2925 and 6725 DPM respectively. The mean DPM/animal value for the vehicle control group was 624 DPM.
Key result
Parameter:
SI
Value:
3.2
Test group / Remarks:
25%
Key result
Parameter:
SI
Value:
4.7
Test group / Remarks:
50%
Key result
Parameter:
SI
Value:
10.8
Test group / Remarks:
100%
Interpretation of results:
other: CLP/EU GHS Category 1, H317 according to Regulation (EC) No. 1272/2008.
Conclusions:
In a LLNA skin sensitisation study, performed according to OECD/EC test guidelines, the source substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]- (EC 911-490-9) was considered to be a skin sensitiser, as the SI appeared to be ≥ 3 when tested up to 100%. The EC3 value (the estimated test substance concentration that will give a SI=3) was established to be between 0 and 25%. Applying the read-across approach, similar results are expexted for the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Justification for read-across

There are no data available regarding skin sensitisation for N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1). Therefore, read-across from an appropriate structural analogue substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13). For skin sensitisation information from the analogue substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-ethanol (EC 911-490-9) will be taken into account to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3.

A Local Lymph Node Aassay was performed according to OECD/EC guidelines and GLP principles with the source substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-ethanol (EC 911-490-9) (WIL Research, 2013b). The source substance was applied at concentrations of 25, 50 or 100%. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. No irritation of the ears was observed in any of the animals examined. The lymph nodes were larger in size in animals at 50 and 100%. The largest auricular lymph nodes were found in the higher dose group. No macroscopic abnormalities of the surrounding area were noted in any of the animals. The SI values calculated for the substance concentrations 25, 50 and 100% were 3.2, 4.7 and 10.8, respectively.

These results show that the test substance elicits an SI≥3. The EC3 value (the estimated test substance concentration that will give a SI=3) was established to be between 0 and 25%. Based on these data, the substance is classified for skin sensitisation in CLP/EU GHS Category 1 since data are not sufficient for sub-categorisation.

The available data with a structural analogue substance regarding skin sensitisation meet the classification criteria for Skin Sens 1, H317 according to Regulation (EC) 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available source substance data regarding skin sensitisation meet the classification criteria for Skin Sens 1, H317 according to Regulation (EC) 1272/2008.