Registration Dossier

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 Glycerides category covers aliphatic (fatty) acid esters of glycerol. The category contains both well-defined and UVCB substances with aliphatic acid carbon chain lengths of C2 (acetate) and C7-C22, which are mostly linear saturated and even numbered. Some of the substances in the category contain unsaturated fatty acids (e.g. oleic acid in 2,3-dihydroxypropyl oleate, CAS 111-03-5 or general fatty acids C16-22 (even) unsaturated in Glycerides, C14-18 and C16-22-unsatd., mono- and di-, CAS 91744-43-7). Some category members contain branched fatty acids. Branching is mostly methyl groups (e.g. isooctadecanoic acid, monoester with glycerol, CAS 66085-00-5 or 1,2,3-propanetriyl triisooctadecanoate, CAS 26942-95-0). In one category member the branching cannot be precisely located (Glycerides, C16-18 and C18-unsatd., branched and linear mono-, di- and tri, ELINCS 460-300-6). Hydroxylated fatty acids are present in three substances (Castor oil, CAS 8001-79-4; castor oil hydrogenated, CAS 8001-78-3 and 2,3-dihydroxypropyl 12-hydroxyoctadecanoate, CAS 6284-43-1). Hydroxylation occurs on C12 of stearic acid in all these substances. Acetylated chains are present in the last part of the category, comprising fatty acids from C8 to C18 (even) and also C18 unsaturated, additionally a C18 acetylated fatty acid is present with the acetic acid located in C12 position (e.g. Glycerides, castor oil mono-, hydrogenated acetates / 12-acetoxy-octadecanoic acid, 2,3-diacetoxy, CAS 736150-63-3). All glycerides build mono-, di- and tri-esters in variable proportions.

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, 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) and within Chapter 5.1 of the CSR.

 

Overview of Skin Sensitisation

CAS

Skin Sensitisation

142-18-7 (a)

RA: CAS 97593-30-1 (C12)

25496-72-4 (b)

WoE:
Experimental result:
not sensitising

6284-43-1

WoE:
RA: CAS 736150-63-3
RA: CAS 91845-19-1

620-67-7

Experimental result:
not sensitising

122-32-7

WoE:
Experimental result:
not sensitising

555-43-1

Experimental result:
not sensitising

26942-95-0

Experimental result:
not sensitising

91052-47-0

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

91744-09-1

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

85536-07-8

WoE:
RA: CAS 97593-30-1 (C12)
RA: CAS 620-67-7
RA: CAS 73398-61-5

91052-49-2

WoE:
RA: CAS 97593-30-1 (C12)
RA: CAS 736150-63-3
RA: CAS 555-43-1

67701-33-1

WoE:
RA: CAS 91845-19-1
RA: CAS 620-67-7
RA: CAS 555-43-1

67784-87-6

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

91845-19-1

Experimental result:
not sensitising

97358-80-0

RA: CAS 26942-95-0

31566-31-1

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

85251-77-0

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

91052-28-7

WoE:
RA: CAS 91845-19-1
RA: CAS 620-67-7
RA: CAS 555-43-1

91052-54-9

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

91744-20-6

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

97722-02-6

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

77538-19-3

Experimental result:
not sensitising

91744-28-4

WoE:
RA: CAS 97593-30-1
RA: CAS 736150-63-3
RA: CAS 555-43-1

68606-18-8

WoE:
RA: CAS 73398-61-5
RA: CAS 620-67-7
RA: CAS 97593-30-1 (C12)

73398-61-5

WoE:
Experimental result:
not sensitising (human)
RA: CAS 620-67-7

85536-06-7

WoE:
RA: CAS 73398-61-5
RA: CAS 620-67-7
RA: CAS 97593-30-1 (C12)
RA: CAS 555-43-1
RA: CAS 91845-19-1

67701-26-2

WoE:
RA: CAS 97593-30-1
RA: CAS 555-43-1
RA: CAS 73398-61-5 (human)

8001-78-3

WoE:
RA: CAS 91845-19-1
RA: CAS 555-43-1

97593-30-1 (C10 )

RA: CAS 97593-30-1 (C12)

97593-30-1 (C12)

Experimental result:
not sensitising

93572-32-8

WoE:
RA: CAS 97593-30-1 (C12)
RA: CAS 736150-63-3
RA: CAS 91845-19-1

91052-13-0

WoE:
RA: CAS 620-67-7
RA: CAS 91845-19-1
RA: CAS 555-43-1
RA: CAS 73398-61-5 (human)

736150-63-3

Experimental result:
not sensitising

(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.

(c) Surrogate substances are either chemicals forming part of a related category of structurally similar fatty acid esters or precursors/breakdown products of category members (i.e. alcohol and fatty acid moieties). Available data on these substances are used for assessment of (eco )toxicological properties by read-across on the same basis of structural similarity and/or mechanistic reasoning as described below for the present category.

(d) Assessment of toxicological properties is conducted also taking into account available data on mixtures of synthetic and/or naturally occurring glycerides (e.g. vegetable oils), which cannot be identified by a (single) CAS/EC number. The test materials short-, medium- and long-chain triglycerides (SCT, MCT, LCT) and their combinations (e.g. MLCT, SALATRIM – a SLCT) comprise triesters of glycerol with fatty acid chain lengths of C2 and C4 (short-chain), C8 and C10 (medium-chain) and C18 saturated/unsaturated (long-chain). The substance “mixture of mono-, di-, and triglycerides of lauric acid” comprises mono-, di and triesters of glycerol with dodecanoic acid (C12). The substance “Modified triglyceride” contains main components: 1,3-dioleoyl 2-palmitoyl triacylglycerol and 1,2-dipalmitoyl 3-oleoyl triacylglycerol, comprising triesters of glycerol with hexadecanoic (C16) and (9Z)-Octadec-9-enoic acid (C18:1). Available data on identity and composition of the individual test material for a given study is provided in the technical dossier.

For all category members registered under REACh a full data set for each endpoint is provided. For substances not subject to the current REACh Phase-in registration, lack of data for a given endpoint is indicated by "--".

 

Skin sensitisation

CAS No. 142-18-7

The skin sensitisation potential of 2,3-dihydroxypropyl laurate was investigated in guinea pigs similar to the non-adjuvant Buehler method described in OECD guideline 406 (Sterner, 1977). In the induction phase of the study, the test substance at 25% concentration in water was applied to the skin of the left dorsum of 10 animals using an occlusive dressing. During induction, three consecutive topical applications for period of 6 h were performed at intervals of 7 days. A control group of 5 animals was treated with water. For challenge exposure on Day 35, the test substance at 25% concentration in water was applied for 6 h to the skin of the right flank of all animals. Skin reactions were evaluated 2, 24 and 48 h after application.None of the treated animals of the test and control group showed any symptoms of dermal irritation after challenge treatment. However, the reliability of the assay was limited due to the lack of a positive control in the assay. Furthermore, no preliminary test was performed to assess a non-irritating concentration for treatment and the number of test and control animals was insufficient for the Buehler test. Therefore, the study was not further taken into account for hazard assessment.

In a further study, performed similar to OECD guideline 406, the skin sensitisation potential of the test substance was studied in male and female guinea pigs according to the maximisation method (CTFA, 1975, cited in CIR, 2004). The animals were induced with the test substance at a concentration of 2%. After epicutaneous challenge treatment with the test substance at 25%, no skin reactions were provoked in the animals of the test groups. However, no details on skin reactions were reported for animals of the control group and no positive control was included in the assay. Therefore, this study does not provide a reliable basis for hazard assessment.

Two studies are available investigating the skin sensitisation potential of 2,3-dihydroxypropyl laurate in a Modified Draize Repeat Insult Patch Test (Danisco Ingredients, 1996 and 1999, cited in CIR, 2004). The studies were performed in 74 and 93 volunteers, respectively. Under occlusive conditions, the test substance at concentrations of 25 or 50% in liquid paraffin was repeatedly applied to the skin of the volunteers for a period of 47 h, which corresponded to a total of nine induction applications. Reactions were scored after each patch removal. The challenge treatment with the respective concentrations of the test substance was performed on Day 35 or 36 of the studies for a period of 47 h. Skin reactions were scored 1 and 49 h after patch removal. In the study with 74 participants, no positive reactions for skin sensitisation were observed at test substance concentrations of 50% in liquid paraffin. However, 7 individuals showed equivocal results in response to treatment. During the induction phase, mild erythema was observed in most of the volunteers. In the study with 93 participants, no skin sensitisation was observed after treatment with the test substance at 25% in liquid paraffin. Moderate erythema was observed in 8/93 and 1/93 individuals during the induction and challenge phases, respectively.

Since both studies originated from secondary literature, the reliability of data was considered limited for risk assessment.

CAS No. 25496-72-4

Five studies are available investigating the skin sensitisation potential of Glycerol monooleate in the human patch test (Osbourn, 1967a-d; Shelanski, 1963).

In the 4 studies performed by Osbourn (1967a-d), the test substance was applied to the skin of up to 203 volunteers under occlusive conditions. For induction, the initial patches remained on the skin for 72 h, whereas the challenge patches were removed after 48 h. The untreated sites of the all volunteers served as control. In two of these patch tests, the test substance did not reveal any skin sensitisation potential (Osbourn, 1967b and c). In the two other studies, volunteers that showed primary skin irritation after induction were further exposed to the test item under semi-occlusive conditions. However, when volunteers were re-exposed to the test item under semi-occlusive patches, a very small number of the volunteers showed equivocal skin reactions. Therefore, it was concluded that the type of application seemed to have a stronger impact on the skin reaction than the test item itself. Thus, the results of these two studies were rather attributed to mild skin irritating than skin sensitising effects.

In a further human patch test by Shelanski (1963), the test substance was applied to the skin of 50 volunteers. For induction, the skin was exposed for 72 h and skin reactions were scored 24, 48 and 72 h after patch removal. Two weeks after the initial application, the volunteers were challenged for 72 h and skin reactions were scored 72 h thereafter. The test item induced erythema in 7 out of 50 volunteers with most of them reacting 72 h after induction exposure. Since no skin reaction occurred after challenge, the test substance was not considered to be sensitiser, whereas a mild skin irritation potential could not be excluded.

CAS No. 620-67-7

The skin sensitisation potential of Propane-1,2,3-triyl trisheptanoate was studied in female guinea pigs according to the non-adjuvant Buehler method (OECD guideline 406) and under conditions of GLP (Mürmann, 1993). A preliminary test in 4 animals was performed with the test substance at 25, 50 and 75% (w/w) in corn oil in order to determine a non-irritant concentration for topical application in the main assay. Since no primary irritation was observed at any test concentration after 6-h exposure, the undiluted test substance was chosen for both the induction and challenge treatment. In the induction phase, the undiluted test substance was applied to the clipped skin of the left flank of 20 animals using an occlusive dressing. During induction, three consecutive topical applications for period of 6 h were performed at intervals of 7 days. A control group of 10 animals was treated with corn oil. For challenge exposure on Day 28, the undiluted test substance was applied for 6 h to the clipped skin of the right flank of all animals. Skin reactions were evaluated 6, 24, 48 and 72 h after application. None of the treated animals of the test and control group showed any symptoms of dermal irritation after challenge treatment. No test substance-related systemic effects and no effects on body weights were observed in the test or control animals. The regularly performed sensitivity test with the positive control 1-chloro-2,4-dinitrobenzene showed the expected results. Based on the results, the test material had no skin sensitising effect in guinea pigs under the experimental conditions chosen.

A further study with the test substance was performed according to the modified Draize method (Thomas, 1974). In this study, 6 guinea pigs were induced and challenged with the undiluted test substance. No sensitising effect was noted during the study. Slight to moderate skin irritation was observed in all animals after induction and at 24 h reading after challenge treatment. However, no positive controls were included in the experiment to confirm the sensitivity and reliability of the test method. Thus, this study was considered as not reliable and therefore not taken into account for hazard assessment.

CAS No. 122-32-7

The skin sensitisation potential of 9-Octadecenoic acid (Z)-, 1,2,3-propanetriyl ester was investigated in 13 volunteers with a known contact allergy to olive oil using the human patch test method (Malmkvist Padoan et al., 1990). The test substance at 30% concentration was applied to a patch and occlusively placed on the skin of 10 women and 3 men for a period of 48 h. After exposure, the test substance was removed and skin reactions were assessed 72 h post-application according to ICDRG recommendations (Fregert and Bandmann, 1975). Negative results were obtained in 9 of 13 volunteers after exposure to the test substance. Under the conditions of this study, the test substance at 30% concentration did not induce skin sensitisation in humans.

Furthermore, a human patch test was performed with the test substance to assess the skin sensitisation potential in 1 male and 1 female test subject with known contact allergy to olive oil (Van Joost, T. et al., 1981). The test substance at a concentration of 30% in vaseline was applied to the skin of the volunteers using a patch. No skin reactions were observed after patch removal. However, study was not reliable, since only limited data on the results were given in the publication.

CAS No. 555-43-1

Glycerol tristearate was investigated in male and female guinea pigs in a GLP-conform Buehler test according to OECD 406 (Krueger, 1998). In a preliminary skin irritation test with 3 female animals, test substance formulations of 10, 20, 30 and 50% in petrolatum were topically applied to the flank under occlusive conditions for 6 h in order to establish a non-irritant concentration for induction. The concentration for challenge exposure was determined in a further 4-week test on 3 animals using the same concentrations. The maximum non-irritant concentration of 50% was used for topical application in the induction and challenge phase of the main assay. In the induction phase, the test substance at concentrations of 50% in petrolatum was applied to the clipped skin of the left flank of 20 animals using an occlusive dressing. During induction, three consecutive topical applications for a period of 6 h each were performed at intervals of 7 days. A control group of 10 animals was treated with the vehicle. For challenge exposure on Day 28, the test substance at 50% concentration in petrolatum and the vehicle only was applied for 6 h to the clipped skin of the posterior and anterior right flank of all animals, respectively. Skin reactions were evaluated 24 and 48 after application. None of the treated animals of the test and control group showed symptoms of dermal irritation after challenge treatment. No test substance-related systemic effects and no effects on body weights were observed in the test or control animals. The positive control substance α-hexyl cinnamic aldehyde showed the expected results thereby confirming the reliability of the study. Based on these results and the experimental conditions chosen, the test substance had no skin sensitising effect in guinea pigs.

A human patch test was performed in 13 volunteers with a known contact allergy to olive oil to assess the skin sensitisation Glycerol tristearate (Malmkvist Padoan et al., 1990). The test substance at 30% concentration was applied to a patch and occlusively placed on the skin of 10 women and 3 men for a period of 48 h. After exposure, the test substance was removed and skin reactions were assessed 72 h post-application according to ICDRG recommendations (Fregert and Bandmann, 1975). In 9 of 13 volunteers the test substance did not induce any skin reactions. Based on the results of this patch test, the test substance at 30% concentration did not induce skin sensitisation in humans.

CAS No. 26942-95-0

In a GLP-compliant guinea pig maximisation test performed according to OECD 406, the skin sensitisation potential of 1,2,3-propanetriyl triisooctadecanoate was studied (Jones, 1987). A preliminary study with up to 2 dose levels was performed in order to determine suitable test concentrations for the main study. Groups of 1-2 guinea pigs were intradermally treated with the test material in arachis oil B.P. at 10 and 25% (w/v) to determine the highest practical concentration for intradermal injection in the induction phase, which was well tolerated both locally and systemically. To identify the highest level which did not produce inflammation or irritation after topical application on the animal with FCA, the undiluted test substance and dilutions of the test material in petroleum jelly B.P. (50, 75 and 100%) were tested. Based on the results of the range finding tests, concentrations of 25 and 100% were selected for intradermal and epicutaneous treatment, respectively. In the induction phase of the main study, intradermal injections of the test substance at 25% in arachis oil and/or FCA were applied into the clipped dorsal area of 20 females. A control group, consisting of 10 females, was injected with vehicle only and/or FCA. On Day 8, a 48-hour epicutaneous induction treatment with test substance at 100% or sham-exposure with a blank filter paper was performed in the treated or control animals on the regions of intradermal injections. On Day 22, the challenge treatment was performed by topical application of the test substance at 100% (right flank) and a blank patch (left flank) to all animals for 24 h. Skin reactions were evaluated 24 and 48 h after the challenge application. During the study, no test substance-related clinical signs and no effects on body weight gain were observed. No cutaneous reactions were observed after challenge treatment with the test substance at 100% in any of the animals of the test and control groups. Formaldehyde in 40% w/v aqueous solution, which served as historical positive control, showed the expected results (> 30% positive response in the animals) and thus verified the reliability of the assay. Based on the results, the test substance had no sensitising effect in guinea pigs under the experimental conditions chosen.

CAS No. 91845-19-1

The skin sensitising potential of Glycerides, C16-18 and C18-hydroxy mono- and di- was studied in guinea pigs according to the maximisation method (OECD guideline 406) and in compliance with GLP (Kästner, 1985). In three preliminary tests, suitable treatment concentrations for the main study were determined in each 5 animals. For the intradermal route, the test substance at concentrations of 1 and 10 % in paraffin was administered to the clipped skin of 5 animals. Based on the induction of moderate irritant effects on the skin but no necrosis, a test substance concentration of 1% in paraffin oil (w/w) was chosen for intradermal injections in the main study. For the cutaneous route, the test substance at 25 and 50% in vaseline was applied to the clipped skin of 5 animals for 48 h using an occlusive dressing within the preliminary experiment. Since the 50% concentration of the test substance was sufficient to cause skin irritation, this concentration was selected for topical application in the induction phase of the main experiment. For challenge exposure, intradermal injections with Freund’s adjuvant followed by epicutaneous application of 0.2 g of the test substance at concentrations of 25 and 50% in vaseline were performed in the preliminary test. After 24-h exposure under occlusive conditions, slight erythema was observed on the skin of 2/5 animals. Thus, the test substance at 25% in Vaseline was chosen for topical application in the challenge phase of the main test. In the induction phase of the main study, intradermal injections of the test substance at 1% in paraffin and/or FCA were applied into the clipped skin area of 20 females. A control group, consisting of 20 females, was injected with vehicle only and/or FCA. On Day 8, a 48-hour epicutaneous induction treatment with test substance at 50% in vaseline or vehicle only was performed in the treated or control animals on the regions of intradermal injections. On Day 22, the challenge treatment was performed by topical application of the test substance at 25% concentration in vaseline and the vehicle to all animals for 24 h. Skin reactions were evaluated 24 and 48 h after the challenge application. During the study no test substance-related clinical signs and no effects on body weight gain were observed. No cutaneous reactions were provoked by the challenge treatment with the test substance at 25% in none of the animals of the test and control groups. Therefore, the test substance had no sensitising effect in guinea pigs under the experimental conditions chosen.

CAS No. 77538-19-3

A Human Repeat Insult Patch Test (RIPT) with 93 volunteers was performed to investigate the skin sensitisation potential of Docosanoic acid ester with 1,2,3-propanetriol (Harrison, 1997). For the induction period, a series of nine induction patchings was performed over a period of 3 weeks. In each induction treatment, the undiluted test substance was occlusively applied to the skin of the volunteers for 24 h. Thereafter, the patches were removed and the skin was scored. After a rest period of 2 weeks, the challenge was performed by application of the test substance for a period of 24 h. The application sites were scored at about 24, 48, 72 and 96 hours after patch removal. In none of the 93 volunteers, positive skin reactions were observed at any of the reading time points. Thus, under the conditions of this RIPT, the test substance was not considered to have any sensitising potential.

CAS No. 73398-61-5

Triglycerides, mixed decanoyl and octanoyl was tested for its skin sensitisation potential in a human Repeated Insult Patch Test (Eisenberg, 1996). 54 volunteers were induced epicutaneously (interscapular back skin) with 0.2 mL of the unchanged test substance for an exposure period of 24 h under semi-occlusive conditions. Inductions were performed three times a week for a total of ten applications. The challenge application was performed two weeks after the last induction on the volar forearm. Skin reactions were observed 24 and 48 h after challenge application on the volar forearm. None of the 54 tested volunteers showed any skin reactions, indicating that the test material was not skin sensitising to human skin under the conditions of this study.

Furthermore, Triglycerides, mixed decanoyl and octanoyl was tested for its skin sensitisation potential using the Buehler test method (Consultox, 1972). Ten epicutaneous induction exposures were performed in 6 guinea pigs with the test substance at a concentration of 4% in ethanol. Epicutaneous challenge treatment was performed with the test substance at 4% in ethanol. No range finding tests were reported. No skin reactions were observed in any of the six tested animals. However, due to the small number of test animals, no corresponding challenge and positive control animals and the fact that the test substance was only applied as a 4% dilution in ethanol, the results of this Buehler test were not considered reliable and therefore not further taken into account for hazard assessment.

CAS No. 97593-30-1

The skin sensitising potential of C12: Glycerides, C8-21 and C8-21-unsatd., mono- and di-, acetates was investigated in a modified Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429 and in compliance with GLP (Vohr, 2008). In this study, 6 female Hsd Win:NMRI mice per test group were treated with test substance at concentrations of 2, 10 and 50% in acetone/olive oil (4:1 v/v) or with the vehicle alone. The test substance formulations or the vehicle were applied epicutaneously onto the dorsal part of each ear (25 µL/ear) for three consecutive days. In order to assess skin irritation, the thickness of both auricles of the animals was measured before the first treatment and prior to sacrifice. In addition, ear weights were determined at necropsy. On Day 4, animals were sacrificed and weight of the lymph nodes was determined. The cell proliferation of pooled lymph nodes from individual animals was measured by counting the cells in suspension using an electronic cell counter. The mean cell count (1000 cells/mL lymph node suspension) for each test group was 9169, 10421 and 10630 at concentrations of 2, 10 and 50% of the test substance, respectively. Treatment with the test substance did not result in a significant increase of absolute number of lymph node cell counts per mL compared to control (cell count = 10962). Based on these results, cell count indices of 0.84, 0.95 and 0.97 were calculated for treatment concentrations of 2, 10 and 50%, respectively. A positive result in this strain of mice was obtained if the cell count index was ≥ 1.4. No local or systemic toxicity and no effects on body weights were observed. No effects on ear weights and ear swelling were observed in the treated animals compared to controls. The historical positive control alpha hexyl cinnamic aldehyde at concentrations of 3, 10 and 30% confirmed the sensitivity and reliability of the experimental technique. Under the above mentioned conditions, the test substance was not found to be a sensitiser in the modified LLNA.

CAS No. 736150-63-3

The skin sensitising potential of Glycerides, castor-oil.mono, hydrogenated, acetates was investigated in a Local Lymph Node Assay (LLNA) in mice performed according to OECD guideline 429 and in compliance with GLP (Meurer, 2007). In this study, 5 female CBA7CaOlaHsd mice per test group were treated with test substance at 10, 20 and 50% (w/v) in dimethyl sulfoxide or vehicle alone, respectively. The test substance formulations or the vehicle were applied topically to the dorsal surface of each ear lobe (25 µL/ear) for three consecutive days. Different batches (A-D) were used for treatment with the test substance at the respective concentrations. Five days after the first topical application, animals were sacrificed and the cell proliferation of pooled lymph nodes from individual animals was measured by incorporation of ³H-methyl thymidine and expressed as the amount of radioactive disintegration per minute (DPM). For batch A, the mean DPM/lymph node for each test group was 1528.3, 2088.3 and 3468.7 at concentrations of 10, 20 and 50% of the test substance, respectively. At 50% concentration of Batch A, a statistically significant difference (p ≤ 0.05) in DPM per lymph node was observed compared to control (DPM/node = 2027.9). Based on these results, stimulation indices of 0.75, 1.03 and 1.71 were calculated for the treatment concentrations of 10, 20 and 50%, respectively. The animals treated with the mid and the highest concentration (25% and 50%) of Batch A showed reddening of the ear skin from the second day of treatment. In summary, stimulation indices at of maximal 0.97 in the 10% groups, 1.53 in the 25% groups and 1.86 in the 50% groups were observed after treatment with the batches A-D of the test substance. Based on this data, no EC3 values of the test groups could be calculated, since none of the tested concentrations induced a stimulation index greater than 3. The positive control substance (25% hexyl cinnamic aldehyde in acetone:olive oil (4+1)) induced positive reactions in 2/5 animals (40%) and thus confirmed the sensitivity and reliability of the experimental technique. Under the above mentioned conditions, the test substance was not found to be a sensitiser in the LLNA.

Overall conclusion for skin sensitisation

Several members of the Glycerides category have been tested for the induction of skin sensitisation, including a number of studies with human volunteers. No skin sensitising potential was observed in any of the available animal and human studies with Glycerides.

Based on the available data and following the category approach, all members of the Glycerides category are considered to be not skin sensitising.


Migrated from Short description of key information:
All available studies showed no skin sensitisation potential of the category members.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 Glycerides category, data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the group concept, the available data on skin 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.