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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Based on the available data, it can be concluded that the available data on skin sensitisation from the source substances MDEA-Esterquat C16-18 and C18 unsatd., MDIPA-Esterquat C16-18 and C18 unsatd., and MDIPA-Esterquat C18 unsatd. can be applied to the target substance MDEA-Esterquat C18 unsatd. There is no evidence of sensitisation potential from the available studies conducted with the source substances.

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:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological and ecotoxicological properties because they share structural similarities with common functional groups: quaternary amines, esters, and fatty acid chains varying in their length and degree of (un)saturation. Moreover, the fatty acid chains are chemically simple structures which have no structural alerts for toxicity, and which are closely related to substances of known low toxicity (i.e. stearic acid, oleic acid, linoleic acid, linolenic acid). Furthermore, the substances can be expected to have comparable breakdown products (MDEA or MDIPA and long chain fatty acids).

This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance MDEA-Esterquat C18 unsatd. are predicted to be similar to those of the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd.

Therefore, read-across from the available physicochemistry, toxicity and ecotoxicity studies with the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd. are considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance MDEA-Esterquat C18 unsatd., in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.


2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to read-across justification attached to Iuclid section 13

3. ANALOGUE APPROACH JUSTIFICATION
please refer to read-across justification attached to Iuclid section 13

4. DATA MATRIX
please refer to read-across justification attached to 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
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Species:
guinea pig
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Remarks:
based on read-across
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No experimental data are available for the target substance MDEA-Esterquat C18 unsatd. However, studies on skin sensitisation potential are avaiable for the structurally related source substances MDEA-Esterquat C16-18 and C18 unsatd., MDIPA-Esterquat C16-18 and C18 unsatd.  and MDIPA Esterquat C18 unsatd.


A justification for read-across is attached to Iuclid section 13.


Two dermal sensitization studies according to OECD guideline 406 using the method of Bühler are available for the source substance with MDEA-Esterquat C16-18 and C18 unsatd. 


In both studies, MDEA-Esterquat C16-18 and C18 unsatd.  is not a dermal sensitizer.


 


In a dermal sensitisation study according to OECD Guideline 406 with MDIPA-Esterquat C16-18 and C18 unsatd. (100% a.i.) in water, young adult female Dunkin-Hartley guinea pigs (10 in test group, 5 in control group) were tested using the method of Magnusson and Kligman.


Based on the results of a preliminary study, the test substance concentrations selected for the main study were a 0.2% concentration for the intradermal induction and a 10% concentration for the epidermal induction exposure. A 1% test substance concentration was selected for the challenge phase.


After epidermal induction all animals of the experimental group showed signs of irritation. Following a challenge exposure to a 1% test substance concentration, one experimental animal showed discrete or patchy erythema, with scaliness, and one experimental animal showed scaliness only, both at 48 hours after exposure. No skin reactions were evident in the control animals and all other experimental animals. The sensitisation rate was 10%. MDIPA-Esterquat C16-18 and C18 unsatd. is not a dermal sensitiser in this study.


 


In a dermal sensitisation study according to OECD guideline 406 with MDIPA Esterquat C18 unsatd. (100% a.i.) 10 young adult Dunkin Hartley, HsdPoc:DH guinea pigs were tested using the method of method of Magnusson & Kligman (Guinea Pig Maximisation Test).


Test concentrations were selected based on the results of a pilot study: intradermal induction 0.5% in sesame oil; epicutaneous induction 25% on sesame oil; challenge 1% in sesame oil. No pretreatment to create local skin irritation was necessary before epicutaneous induction as the selected concentration was slightly irritating.


After challenge no visible changes of the treated skin sites were observed in the test and control group animals 24 and 48 h after patch removal (= grade 0).


The test material produced a response in 0% of animals. MDIPA Esterquat C18 unsatd. is not a dermal sensitiser in this study.


 


Conclusion


Based on the available data, it can be concluded that the available data on skin sensitisation from the source substances MDEA-Esterquat C16-18 and C18 unsatd., MDIPA-Esterquat C16-18 and C18 unsatd., and MDIPA-Esterquat C18 unsatd. can be applied to the target substance MDEA-Esterquat C18 unsatd. There is no evidence of sensitisation potential from the available studies conducted with the source substances.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on relevant, reliable and adequate data MDEA Esterquat C18 unsatd. does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to skin sensitisation.