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EC number: 252-552-9 | CAS number: 35415-27-1
Endpoint summary
Administrative data
Description of key information
For the submission substance, no data for testing sensitising effects on the skin are available. However adequate and reliable data for a structural analogue (i.e. C8C10TM, for read-across justification please see read-across report in section 13) revealed no sensitising potential when tested in a guinea pig maximisation test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed no sensitising effect on guinea pig skin under the test conditions of this OECD guideline study.
- Executive summary:
The study used as source investigated dermal sensitising effects of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters in guinea pigs by the Magnusson and Kligman maximisation test according to OECD guideline 406 (12 May 1981).
The preliminary test showed that the undiluted test substance caused no dermal irritation. In order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area was pretreated with sodium dodecyl sulphate (10% in vaseline). All FCA treated injections sites (diluted 1 +1 with maize germ oil), assessed 1 and 24 hours after intradermal induction treatment, showed severe erythema, edema and necrosis. The control animals had comparable signs of irritation at the injection sites.
The reactions to the dermal induction treatment for 48 hours were described as follows: 1 hour after patch removal, test and control animals showed erythema and edema in the whole application area, as well as inflamed or bloody lesions, the animals were restless and showed scratching in the application area. 24 hours after patch removal some animals showed erythema and eschar formation in the whole application area.
The first challenge treatment was carried out with the undiluted test substance (100%). No signs of dermal irritation were found on the test animals or the control animals 48 and 72 hours after the challenge treatment. No second challenge was carried out. On the basis of these results, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was assessed as having no sensitising effect on the skin of guinea pigs.
Results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross-reference “assessment report”.
Reference
RESULTS OF PILOT STUDY: no irritation at concentrations of 100% test substance
RESULTS OF TEST
- Sensitization reaction: 0/20
- Clinical signs: Local reactions after intradermal application (test and control animals after 1 and 24 hours): All FCA treated injections sites showed severe erythema, edema and necrosis. The animals treated with 10% test substance in maize germ oil showed well defined erythema and edema.
Local reactions after patch test (48 hours): 1 hour after patch removal, test and control animals: whole application area showed erythema and edema, as well as inflamed or bloody lesions, restlessness of the animals and scratching in the application area.
24 hours after patch removal: Some animals showed erythema and eschar formation in the whole application area.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For the submission substance, no data for testing sensitising effects on the skin are available. However adequate and reliable data for a structural analogue (i.e. C8C10TM, for read-across justification please see read-across report in section 13) are summarised below.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was tested for dermal sensitisation in guinea pigs by the Magnusson and Kligman maximisation test according to OECD guideline 406 (12 May 1981).
The sensitising potential of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was determined using a test group of 20 and a control group of 10 animals. All reactions, especially the formation of erythema and oedema, were assessed 48 and 72 hours after the challenge treatment. The maximum concentration which caused no dermal irritation in a prelinminary test was found to be 100% test substance (as supplied).
The following concentrations of test substance were used for the induction treatments: the test substance was employed in a 10% mixture with maize germ oil for the intracutaneous injection, while the 100% test substance (as supplied) was used for the dermal treatment.
The preliminary test showed that the undiluted test substance caused no dermal irritation. In order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area was pretreated with sodium dodecyl sulphate (10% in vaseline).
All FCA treated injections sites (diluted 1 +1 with maize germ oil), assessed 1 and 24 hours after intradermal induction treatment, showed severe erythema, edema and necrosis. The control animals had comparable signs of irritation at the injection sites.
The reactions to the dermal induction treatment for 48 hours were described as follows: 1 hour after patch removal, test and control animals showed erythema and edema in the whole application area, as well as inflamed or bloody lesions, the animals were restless and showed scratching in the application area. 24 hours after patch removal some animals showed erythema and eschar formation in the whole application area.
The first challenge treatment was carried out with the undiluted test substance (100%). No signs of dermal irritation were found on the test animals or the control animals 48 and 72 hours after the challenge treatment. No second challenge was carried out.
On the basis of these results, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was assessed as having no sensitising effect on the skin of guinea pigs (Sasol_Mürmann, 1989, RL2).
Justification for selection of skin sensitisation endpoint:
Onyl study available. Adequate study performed with structural analogue and of high reliability (Klimisch score 2, according to guideline, no GLP)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the negative findings in a reliable guideline study performed with the structural analogue 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (C8C10TM) no classification for skin sensitisation according to the criteria set in the Regulation (EC) No. 1272/2008 is proposed for the submission substance.
No data for respiratory sensitisation is available.
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