Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Justification for grouping of substances and read-across

The Glycol ester category covers esters of an aliphatic diol (ethylene glycol (EG), propylene glycol (PG) or 1,3-butyleneglycol (1,3-BG)) and one or two carboxylic fatty acid chains. The fatty acid chains comprise carbon chain lengths ranging from C6 to C18, mainly saturated but also mono unsaturated C16 and C18, branched C18 and epoxidized C18.

 

The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. 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 grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).

 

Skin sensitisation

 

Data Matrix 

CAS #

Skin sensitisation

111-60-4 (b)

Not sensitising

624-03-3 (a)

RA: CAS 627-83-8

627-83-8

Not sensitising

91031-31-1

RA: CAS 627-83-8

151661-88-0

Not sensitising

29059-24-3

Not sensitising

37321-62-3

Not sensitising

68583-51-7

RA: CAS 29059-24-3

RA: CAS 853947-59-8

RA: CAS 37321-62-3

84988-75-0

RA: CAS 627-83-8

RA: CAS 853947-59-8

RA: CAS 29059-24-3

853947-59-8

Not sensitising

 4219 -49 -2

  

RA: CAS 627-83-8

(a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.

(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font.

 

 

CAS 853947-59-8

The skin sensitising potential of Butylene glycol dicaprylate / dicaprate was investigated in a Guinea pig maximisation test according to OECD guideline 406 under GLP conditions (Mürmann, 1992a).

Following a preliminary range finding test, female Dunkin Hartley guinea pigs (20 in test group, 10 in control group) were induced with a single intradermal injection of the test substance at 10% in maize germ oil MEH56. Epicutaneous occlusive application of the undiluted test substance was performed 7 days later. The negative control group was treated with maize germ oil MEH56. Epicutaneous challenge exposures were conducted 20 days after the first induction for 24 h under occlusive conditions. The undiluted test substance was applied on the right flank and evaluation of skin reactions was carried out 24 and 48 h after application. After intradermal injection of Freund´s adjuvans and test substance or vehicle only, all test and control animals showed severe erythema and oedema after 24 h. After challenge, all test and control animals showed no skin reactions after 24 and 48 h. The sensitivity of the test system was reported to be checked at regular intervals; however, the data were not included in the study report (Mürmann, 1992a).

In summary, based on the available data on the skin sensitisation properties, it is concluded, that there is no evidence of sensitising properties of Butylene glycol dicaprylate / dicaprate.

 

CAS 29059-24-3

The skin sensitising potential of Myristic acid, monoester with propane-1,2-diol (CAS 29059-24-3)was investigated in a Guinea pig maximisation test according to EU method B.6 (Kästner, 1989). In a preliminary range finding test was conducted to evaluate the suitable concentrations for the main study for the intradermal injection and the patch testing. In the main study, 20 female Pirbright white guinea pigs were induced with a single intradermal injection of the test substance at 0.1% in Paraffin perliquid DAB 8 and an epicutaneous occlusive application of the test substance at 15% on the shoulder region 7 days later. A negative control group of 20 animals was treated with Paraffin perliquid DAB 8 only. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions at concentrations of 2.5% and 5% of the test substance, respectively. All test and control animals showed no skin reactions after 24 and 48 h with one exception only. In one control animal, a slight redness of the skin after 48 h was apparent. No positive control data was included in the study report for reliability check (Kästner, 1989)

 

CAS 37321-62-3

The skin sensitising potential of Dodecanoic acid, ester with 1,2-propanediol (CAS 37321-62-3) was investigated in a Guinea pig maximisation test according to OECD guideline 406 under GLP conditions (Mürmann, 1992b). Following preliminary range finding tests, male and female Dunkin Hartley guinea pigs (20 in test group, 10 in control group) were induced with a single intradermal injection of the test substance at 10% in corn oil. Epicutaneous occlusive application of the undiluted test substance was performed 7 days later. The negative control groups were treated with corn oil. Epicutaneous challenge exposures were conducted 20 days after the first induction for 24 h under occlusive conditions. The undiluted test substance was applied on the right flank and evaluation of skin reactions was carried out 24, 48 and 72 h after application. After intradermal injection of Freund´s adjuvans and test substance or vehicle only, all test and control animals showed severe erythema and oedema after 24 h. After challenge, all test and control animals showed no skin reactions after 24, 48 and 72 h. The sensitivity of the test system was reported to be checked at regular intervals; however, the data were not included in the study reports (Mürmann, 1992b).

In summary, based on the available data on the skin sensitisation properties, it is concluded, that there is no evidence of sensitising properties of Dodecanoic acid, ester with 1,2-propanediol.

 

 

CAS 627-83-8

One study each, investigating the skin sensitising potential of ethylene distearate (CAS No. 627-83-8) is available in humans and animals, respectively.

The animal study was performed according to a Buehler test protocol similar to OECD guideline 406 in Hartley guinea pigs (Müller, 1984). The solid test material was mixed with a few drops of water and applied at a concentration of 100% for epidermal induction and challenge. The negative control group was treated with the vehicle only. No positive control data was included in the study report for reliability check. At challenge, the neat test substance induced no skin effects in the test and negative control group. No further skin reactions after induction and challenge were observed. In addition, a sensitisation study with guinea pigs with limited details is available (Elder, 1982). Two animals were intradermally induced and challenged with 0.1% glycol distearate in a saline solution and showed no skin reactions.

In summary, based on all available data, ethylene distearate is not sensitising.

 

Additional data

In addition, the category members Glycol Stearate (CAS 111-60-4) and Fatty acids, C18 and C18 unsatd. epoxidized, ester with ethylene glycol (CAS 151661-88-0) did not show skin sensitisation properties, as well.

 

Conclusion for skin sensitisation properties

In conclusion, no skin sensitisation properties of the category members Ethylene distearate (CAS 627-83-8), Myristic acid, monoester with propane-1,2-diol (CAS 29059-24-3), Butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and Dodecanoic acid, ester with 1,2-propanediol (CAS 37321-62-3) were apparent in several in vivo studies. Altogether, the available data were consistently negative and thus there is no evidence for skin sensitisation properties of any category member of the Glycol Ester group.

 

For a detailed reference list please refer to the CSR or IUCLID section 13.


Migrated from Short description of key information:
Skin sensitisation: not sensitising (OECD 406, category approach)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:
This information is not available.

Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the group concept is applied to the members of the Glycol Ester Category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.

Therefore, based on the group concept, all available data on sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

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