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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No guideline followed. Only few data on test method reported.
GLP compliance:
no
Type of study:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 400 g
Route:
other: subcuatenous
Vehicle:
no data
Concentration / amount:
Induction: 5 µg per animal
Challenge: 15 µg per animal
Route:
other: intraperitoneal
Vehicle:
no data
Concentration / amount:
Induction: 5 µg per animal
Challenge: 15 µg per animal
No. of animals per dose:
12 animals per one dose.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21.
- Exposure period: 21 days
- Test groups: Only 1 group.
- Site: Subcutaneous.
- Frequency of applications: Once a day.
- Duration: 21 days.
- Concentrations: 5 µg/animal

B. CHALLENGE EXPOSURE
- No. of exposures: One.
- Day(s) of challenge: Day 37 after the last induction exposure.
- Test groups: Only 1 group.
- Site: Intraperitoneal.
- Concentrations: 15 µg/animal
:
Reading:
1st reading
Group:
test chemical
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: None.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
In the present study, the intraperitoneal injection of the test substance did not cause an allergic reaction after 21 days induction period of daily subcutaneous injections.
Executive summary:

In the present study, a group of 12 guinea pigs received daily subcutaneous injections of 5 µg of the test substance for 21 days as Induction phase. After an internval of 37 days, the challenge phase was carried out through an intraperitoneal injection of 15 µg the test item.

None of the animals suffered any allergic reactions and therefore the test item can be considered as not sensitizer.

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

Supporting study: In the present study, a group of 12 guinea pigs received daily subcutaneous injections of 5 µg of the test substance for 21 days as Induction phase. After an internval of 37 days, the challenge phase was carried out through an intraperitoneal injection of 15 µg of the test item. None of the animals suffered any allergic reactions and therefore the test item can be considered as not sensitizer.


Migrated from Short description of key information:
Supporting study: The test item did not produce any allergic reactions in guinea pigs subjected to subcutaneous induction and intraperitoneal challenge phases.

Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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