Registration Dossier
Registration Dossier
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EC number: 246-495-9 | CAS number: 24851-98-7
Endpoint summary
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:
Table 1: Animal Skin Sensitization studies
Test Guideline
Test concentrations
N° of animal/
dose
Klimishcode
Result
OECD 406 (GPMT)
100% v/v
10
1
Not sensitizing
OECD 429 (LLNA)
0-40% v/v in AOO (4:1)
5
1
Not sensitizing
OECD 406 (Buhler Test))
10% v/v in propylene glycol
11
3
Not sensitizing
AOO: Acetone Olive oil (4:1)
Both GPMT and LLNA were selected as key studies as LLNA is the current test of choice to assess skin sensitization concern whereas GPMT was the former one. Both tests were performed according to OECD recommended test guidelines without deviations (excepted LLNA where test substance concentration was tested up to 40%). Furthermore both tests fully cover the composition ranges selected for this substance (high trans and high cis qualities respectively).
Buhler test was selected as supporting study; as this test carried out in 1970 was performed before the establishment of skin sensitization test guidelines (OECD, EU), therefore some parameters (test concentration, absence of control group) where not taken in account in this test. However, this study supports the results obtained with the GPMT and LLNA.
GPMT, LLNA and Buhler tests clearly show that no evidence of skin sensitization occurs when substance is applied to the skin whereas three additional human tests described as full study report and key studies in the section 7.10.4 (Sensitization in humans), also covering composition ranges of the test substance, strongly corroborate these results for human uses (See table 2 below and Toxicological Information Summary).
Table 2: Human Skin Sensitization studies
Test Guideline
Test concentrations
N° of humans/
dose
Klimishcode
Result
HRIPT
20% in DEP
100
1
Not sensitizing in humans
HRIPT
20% in DEP/EtOH
111
1
Not sensitizing in humans
Human Maximization Test
10 % in white petrolatum
25
4
Not sensitizing in humans
HRIPT: Human Repeated Insult Patch Test
DEP: DiethylPhtalate
EtOH: Ethanol
Migrated from Short description of key information:
Guinea Pig Maximisation Test according to OECD 406 (Klimish 1), tested at 100% (v/v) on 10 guinea pigs+5 controls: No sensitization
LLNA equivalent to OECD 429 (Klimish1), tested from 0 to 40% (acetone/ olive oil v/v) on 5 mouse/concentration: No sensitization (SI (1-40%) ≤ 1.7)
Buhler Test equivalent to OECD 406 (Klimish 3), tested at 10% in propylene glycol on 11 guinea pigs/concentration: No sensitization.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Not Performed/Not Applicable
Migrated from Short description of key information:
Not Performed/Not Applicable
Justification for classification or non-classification
Not Performed/Not Applicable
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