Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD guideline with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Envigo CRS GmbH

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

EC Number:

269-798-8

EC Name:

Benzene, (1-methylethyl)-, oxidized, polyphenyl residues

Cas Number:

68333-89-1

Molecular formula:

Cannot be given for UVCB

IUPAC Name:

not applicable

Test material form:

liquid: viscous

Details on test material:

Black viscous liquid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

male/female

Details on test animals and environmental conditions:

Source: Envigo RMS B.V., Inc
Postbus 6174
5960 AD Horst / The Netherlands
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.

Housing: group
Cage Type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 + 2°C
relative humidity approx. 45-65% (except for deviations)
artificial light 6.00 a.m. - 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

1, 2.5, and 5% (w/w)

No. of animals per dose:

Number of animals for
pre-test: 6 females (2 for each pre-test)
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1

Details on study design:

The proliferative response of the lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/lymph node) and as the ratio of 3HTdR incorporated into lymph node cells of test animals relative to that recorded for lymph nodes of control animals (Stimulation Index; S.I.). Before DPM/lymph node values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
A test item is regarded as a sensitisersensitizer in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the Stimulation Index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

Positive control substance(s):

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

Statistics:

The mean values and standard deviations were calculated in the body weight tables.

Results and discussion

Positive control results:

S.I. values from 10 last positive controls all above 3.7 (latest from 10 2015: 17.56)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Stimulation Indices of 1.16, 1.52, and 2.00 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: DPM of 5872, 6795, 8899 and 11736 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF.

Any other information on results incl. tables

Viability / Mortality

No deaths occurred during the study

Clinical Signs

No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the stu

Body Weights

The body weight of the animals, recordedprior to the first application and prior to treatment with³HTdR, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The test item High Boiler, Z-Oil was not a skin sensitiser under the test conditions of the local lymph node assay.

Executive summary:

A local lymph node assay was performed using test item concentrations of 1, 2.5, and 5% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.16, 1.52, and 2.00 were determined with the test item at concentrations of 1, 2.5, and 5% (w/w) in DMF, respectively.