Registration Dossier

Administrative data

Description of key information

Terphenyl, hydrogenated was very well tolerated in 51 human individuals after tests according to the Shelanski repeat insult test and was shown to be not sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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other: No guideline followed, well-documented, available as unpublished report, minor restrections in reporting but otherwise adequate for assessment.
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.
Species:
human
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A key study for sensitisation was performed in 51 humans with Terphenyl, hydrogenated according to Shelanski repeat insult method, this method was considered to be reliable, adequate and relevant (Product investigations Inc., 1979). There was no evidence that the test material acted as a sensitizer in any of the individuals. Further, a supportive study was available according to the same method in 50 individuals. There was no evidence that the test material acted as a sensitizer. It is therefore unlikely that this material would present a danger of irritation or sensitization in normal intended use.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The endpoint does not meet classification criteria according to EU and/or CLP criteria.