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:

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