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Toxicological information

Skin sensitisation

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Administrative data

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other: No guideline followed, well-documented, available as unpublished report, minor restrections in reporting but otherwise adequate for assessment.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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Amber liquid

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Results
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.

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.