Registration Dossier

Administrative data

Description of key information

LLNA (OECD 429): not sensitising (read-across)

GPMT (OECD 406): not sensitising (read-across)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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:
refer to analogue justification provided in IUCLID section 13
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Challenge: 100%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Source: CAS 11138-60-6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Challenge: 100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Challenge: 50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Challenge: 100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Challenge: 50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Challenge: 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Source: CAS 11138-60-6
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 11138-60-6. In the guinea pig maximisation test, no skin sensitisation was observed. The read-across approach is justified in the analogue justification. The target and the source substance are considered unlikely to differ in their skin sensitising potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have a skin sensitising potential.
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:
read-across source
Parameter:
SI
Test group / Remarks:
25%
Remarks on result:
not measured/tested
Remarks:
Source: CAS 95912-89-3
Parameter:
SI
Test group / Remarks:
50%
Remarks on result:
not measured/tested
Remarks:
Source: CAS 95912-89-3
Parameter:
SI
Test group / Remarks:
100%
Remarks on result:
not measured/tested
Remarks:
Source: CAS 95912-89-3
Parameter:
other: Lymph node cell count
Value:
1.029
Test group / Remarks:
25%
Remarks on result:
other: Source: CAS 95912-89-3
Parameter:
other: Lymph node cell count
Value:
1.308
Test group / Remarks:
50%
Remarks on result:
other: Source: CAS 95912-89-3
Parameter:
other: Lymph node cell count
Value:
1.212
Test group / Remarks:
100%
Remarks on result:
other: Source: CAS 95912-89-3
Parameter:
other: Lymph node weight
Value:
0.962
Test group / Remarks:
25%
Remarks on result:
other: Source: CAS 95912-89-3
Parameter:
other: Lymph node weight (g)
Value:
1.173
Test group / Remarks:
50%
Remarks on result:
other: Source: CAS 95912-89-3
Parameter:
other: Lymph node weight (g)
Value:
1.135
Test group / Remarks:
100%
Remarks on result:
other: Source: CAS 95912-89-3
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 95912-89-3. In the local lymph node assay, no skin sensitisation was observed. The read-across approach is justified in the analogue justification. The target and the source substance are considered unlikely to differ in their skin sensitising potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have a skin sensitising potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Justification for read-across

Experimental data on skin sensitisation of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid are not available. The assessment was therefore based on studies conducted with analogue source substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. 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 analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

CAS 95912-89-3

To assess the skin sensitisation potential of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3), a modified LLNA in NMRI mice was performed according to OECD 429 and under the conditions of GLP (Key, 2012). Based on a preliminary experiment in 3 animals, the undiluted test substance (100%) and dilutions of the test substance in acetone/olive oil (3+1 v/v) at concentrations of 25 and 50% (w/w) were tested in six female mice per group. During 3 consecutive days, the dorsal surface of both ears of each animal was epidermally treated once daily with the undiluted test substance and their respective dilutions (25 μL/ear). Two similar constituted groups were exposed to the vehicle and the positive control substance hexyl cinnamic aldehyde at a concentration of 25% in the vehicle, respectively. Before the first application of the test substance and at sacrifice (Day 4 of the study), skin irritation was assessed by measuring the ear thickness of the animals. In addition, punch biopsies of the apical area of both ears were prepared and weight for the determination of irritating effects. Furthermore, the draining (auricular) lymph node of each ear was excised and weighed for the assessment of skin sensitisation. Single cell suspensions of pooled lymph nodes from each individual animal per group were prepared and cell proliferation was measured by automatically counting the lymph node cells. Stimulation indices were calculated for the lymph node cell count, lymph node weight, ear weight and ear thickness by dividing the average values per group of the test item treated animals by the vehicle treated ones. Treatment with test substance at concentrations of 25%, 50% or 100% did not reveal statistically significantly increased values for lymph node cell count. The stimulation indices (SI) of the lymph node cell count of the test substance (1.029, 1.308 and 1.212 at 25, 50 and 100%, respectively) did not exceed the threshold level for a positive result (SI > 1.4). Since the threshold level for the SI of the ear weight was not exceeded (SI < 1.1) and no increase of ear thickness was observed, the test substance was not considered to show irritating properties. The positive control substance hexyl cinnamic aldehyde induced the expected increase in lymph node cell count (SI > 1.4) and lymph node weight (statistically significant at p ≤ 0.01), thereby verifying the validity of the study. No signs of local or systemic intolerance were recorded and the body weight of the animals was not affected by treatment. Under the present test conditions, the test substance at concentrations of 25% and 50% (w/w) in acetone/olive oil (3+1 v/v) and the undiluted test substance (100%) did not reveal any sensitising properties in the local lymph node assay. Based on the available data, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane is not sensitising.

CAS 11138-60-6

A Guinea Pig Maximisation Test was performed with Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) according to OECD 406 under GLP conditions (Key, 1997). 20 male and female Dunkin-Harley guinea pigs were treated with the test substance and compared with 10 negative control animals (5 per sex). A 5% dilution of the test substance in propylene glycol was used for intradermal induction on the shoulder region on Day 1. 100% of the test item was used for topical induction on the shoulder region on Day 8. 14 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted test substance. 24 hours after challenge, one out of twenty animals (5%) showed a skin reaction compared to 3 out of ten (30%) for the positive control. 48 hours after challenge none of the test animals showed any skin reactions. The sensitivity of the animal strain was tested confirmed using Hexylcinnamic aldehyde (HCA) as a positive control substance. Thus, the test substance is not considered to have skin sensitizing potential. In summary, Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol is not considered to have skin sensitising potential.

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 analogue concept is applied to Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.