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Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the available data, it can be concluded that the available data on acute toxicity 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 relevant intrinsic acute toxicity of, thus, classification and labelling with regard to acute toxicity is not warranted.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on read-across, the oral LD50 of MDEA-Esterquat C18 unsatd. is >2000 mg/kg bw in rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No experimental data are available for the target substance MDEA-Esterquat C18 unsatd. However, acute toxicity are available 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.
In an acute oral toxicity study comparable to now deleted OECD guideline 401, groups of fasted, WISW rats 5 males and 5 females were given a single oral dose of MDEA-Esterquat C16-18 and C18 unsatd. (40 % w/w a.i.) in oleum arachidis at a dose of 10000 mg/kg bw. No mortality occurred in this limit test. MDEA-Esterquat C16-18 and C18 unsatd. is practically non-toxic based on the LD50 combined of > 10 000 mg/kg bw. There were no treatment related clinical signs, necropsy findings or changes in body weight. A slight piloerrection was observed in 2/10 animals during the first hour after application. Afterwards they showed a normal disposition.
In an acute oral toxicity study according to OECD guideline 423 (17 December 2001) and EU method B.1 tris (30 May 2008), 6 fasted, approx. 10 weeks old female Wistar Crl:WI (Han) rats were given an oral dose of MDIPA-Esterquat C16-18 and C18 unsatd. (100% a.i.) at a limit dose of 2000 mg/kg bw administered as two dosages of 1000 mg/kg bw within 4 h. Animals were then observed for 14 days.
No animal died during the observation period, hunched posture was noted for all animals (with piloerection for one animal) on days 1 and 2. The body weight development of the animals was within normal range for animals of the same age and strain. The necropsy at the end of the observation period showed no macroscopically visible test substance related pathologic organ findings. Oral LD50 Females > 2000 mg/kg bw
In an acute oral toxicity study according to OECD guideline 423 (17 December 2001) and EU method B.1 tris (30 May 2008), 6 fasted, approx. 11 weeks old female White Wistar, HsdCpb: WU rats were given a single oral dose of undiluted MDIPA Esterquat C18 unsatd. (100% a.i.) at a limit dose of 2000 mg/kg bw and observed for 14 days.
No animal died during the observation period, no clinical signs were observed. The body weight development of the animals was positive and within normal range. The necropsy at the end of the observation period showed no macroscopically visible test substance related pathologic organ findings. Oral LD50 Females > 2000 mg/kg bw
Conclusion
Based on the available data, it can be concluded that the available data on acute toxicity 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 relevant intrinsic acute toxicity of, thus, classification and labelling with regard to acute toxicity is not warranted.
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 toacute toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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