Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P',P'-tetratridecylbis(phosphine)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P',P'-tetratridecylbis(phosphine)

EC Number:

235-841-4

EC Name:

Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P',P'-tetratridecylbis(phosphine)

Cas Number:

13003-12-8

Molecular formula:

C78H144O6P2

IUPAC Name:

4-[2-(4-{[bis(tridecyloxy)phosphanyl]oxy}-5-tert-butyl-2-methylphenyl)pentyl]-5-methyl-2-(propan-2-yl)phenyl ditridecyl phosphite

Test material form:

liquid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Sex:

female

Details on test animals and environmental conditions:

Acclimatisation
After veterinary examination for good health, the mice were received into the experimental procedure room and allowed to acclimatise to the laboratory conditions for a minimum period of 5 days. During the acclimatisation period, the mice were observed daily for any clinical signs of disease. Following acclimatisation, the mice will be rechecked prior to allocation to the study.

Housing
Animals were housed in solid floor polypropylene mouse cages (size: 290 mm x 220 mm x 140 mm). Each cage was fitted with a top grill having provision for keeping rodent pellet feed and a polypropylene water bottle with a stainless steel drinking nozzle. During acclimatisation the animals were housed in group (5 mice/cage). On the day of first test item application (Day 0) and on days 1 and 2, the animals were housed in individual cages. From day 3 the animals were group-housed 5 mice/cage.The bottom of the cages were layered with clean sterilized the bedding material. On day 5 post-administration of the radio labelled material, the animals were transferred to the metal metabolic cages.

Study design: in vivo (LLNA)

Vehicle:

methyl ethyl ketone

Concentration:

5%, 25% and 50% (v/v) in methyl ethyl ketone (MEK)

No. of animals per dose:

5

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

Positive control was valid with a SI=6.23

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.43

Test group / Remarks:

5%

Results 2

Parameter:

SI

Value:

2.22

Test group / Remarks:

25%

Results 3

Parameter:

SI

Value:

2.66

Test group / Remarks:

50%

Any other information on results incl. tables

Group N°	Dose Concentration	N° of Mice Used	Group Mean DPM	Standard Deviation	Stimulation Index (SI)
G1	Vehicle (MEK)	5	1314.00	341.78	1
G2	5% (v/v) Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P’,P’-tetratridecylbis (phosphine)	5	1879.20	260.56	1.43
G3	25% (v/v) Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P’,P’-tetratridecylbis (phosphine)	5	2923.60	654.96	2.22
G4	50% (v/v) Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P’,P’-tetratridecylbis (phosphine)	5	3498.60**	700.25	2.66
G5	25% (v/v) HCA	5	8186.00**	1835.96	6.23

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the LLNA study, the test substance was determined not to be a skin sensitiser.

Executive summary:

Based on the results of the LLNA study, the test substance was determined not to be a skin sensitiser.