Terphenyl, hydrogenated

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline followed, well-documented, available as unpublished report, minor restrections in reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Method: other: Shelanski and Shelanski Repeated Insult Patch Test

GLP compliance:

no

Type of study:

other: Repeated Insult Patch Test

Justification for non-LLNA method:

This test was conducted in 1979, a long time before the LLNA had been set as preferable method for generation of skin sensitisation data.

Test material

Test material information

Constituent 1

Reference substance name:

Terphenyl, hydrogenated

EC Number:

262-967-7

EC Name:

Terphenyl, hydrogenated

Cas Number:

61788-32-7

Molecular formula:

C18Hn (n >18-36)

IUPAC Name:

Terphenyl, hydrogenated

In vivo test system

Test animals

Species:

human

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

0.2 ml

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

0.2 ml

No. of animals per dose:

51 human subjects

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 15 induction doses
- Exposure period: 24 hours for each induction dose
- Frequency of applications: 1 every 2 days
- Duration: 5 weeks
- Concentrations: 0.2 ml

B. CHALLENGE EXPOSURE
- No. of exposures: 1 challenge dose
- Exposure period: 24 hours
- Concentrations: 0.2 ml
- Evaluation (hr after challenge): 24, 48 and 72 hours

OTHER:
- Interval between last induction dose and challenge dose: 14 days

Challenge controls:

No

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.2 ml

No. with + reactions:

0

Total no. in group:

51

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml. No with. + reactions: 0.0. Total no. in groups: 51.0.

Any other information on results incl. tables

SUMMARY: Number of Responses in each Grade

	INDUCTION PERIOD															CHALLENGE
	Week 1			Week 2			Week 3			Week 4			Week 5			Week 8
	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	Im	24h	48h	72h
0	51	51	51	51	51	51	51	49	51	51	51	51	51	51	51	51	51	51	51
Ø	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
?	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
½	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1+	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
2+	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3+	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
4+	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NP	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
np	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NS	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	51	0	0	0

 0 – No visible irritation, or no difference from surrounding, untreated skin.

Ø – Change in appearance of skin of contact site not attributed to test material.

? – Questionable status as to presence of any change.

½ - Mild erythema covering less than half of the contact site.

1+ - Erythema confined to the contact site and exceeding that of the untreated skin.

2+ - Erythema confined to the contact site and definitely exceeding that of untreated skin, papules may or may not be present.

3+ - Erythema, with some degree of induration, papules may or may not be present.

4+ - Erythema, induration, with one or more complications such as: extension beyond margins of contact area, vesiculation, ulceration.

NP – No patch applied.

np – No patch applied, reasons unrelated to test material.

A – Absent.

NS – New site.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no instances of irritation or sensitization

Executive summary:

There was no evidence that the test material acted as a sensitizer in any of the 51 individuals in the Shelanski repeat insult test. It is unlikely that this material would present a danger of irritation or sensitization in normal intended use.