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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: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journals
Qualifier:
according to
Guideline:
other: Modified FCA method and Guinea pig maximization test
Principles of method if other than guideline:
Modified FCA method and Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
other: Modified FCA method and Guinea pig maximization test
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
other: Pirbrigjht white strain
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data available
- Age at study initiation: No Data available
- Weight at study initiation:280-350 g
- Housing: animals were kept 3 to a cage
- Diet (e.g. ad libitum):altromin ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No Data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-24⁰C
- Humidity (%):50-55%
- Air changes (per hr): No Data available
- Photoperiod (hrs dark / hrs light): Under artificial illumination for 10 hours a day
Route:
intradermal
Vehicle:
other: FCA and saline
Concentration / amount:
15 mg
Day(s)/duration:
5th and 9th day
Adequacy of induction:
not specified
No.:
#10
Route:
epicutaneous, open
Vehicle:
other: Acetone
Concentration / amount:
0.05ml
Adequacy of challenge:
other: subirritent concentration.
No. of animals per dose:
Induction route-10
Challenge route-10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period:9 days
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: Intradermal induction -Intraderma injection of 6x0.10-0.15 ml of emulsion were applied.The emulsion was applied in a semicircular arc on clipped and shaved shoulder area (4Х6 cm) from left to right.
- Frequency of applications: repeated on 5th and 9th days
- Duration: 9 days
- Concentrations: 15 mg in 4 ml FCA

B. CHALLENGE EXPOSURE
- No. of exposures: multiple times
- Day(s) of challenge: 11 days after induction, animals were challenged.
- Exposure period:5 mins
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: clipped and shaved skin of the right flank of treated animals.
- Concentrations:0.05ml
- Evaluation (hr after challenge): after 24, 48 and 72 hr.
Challenge controls:
No data available.
Positive control substance(s):
not specified
Key result
Reading:
other: Mean
Hours after challenge:
72
Group:
test group
Dose level:
0.05ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Non sensitizer
Remarks on result:
no indication of skin sensitisation

Sensitizer

Challenged with

Concentration

24 hour

48

hour

72

hour

24 hour

48

hour

72

hour

 

 

 

+++

++

+

(+)

0

-

-

-

-

10

+++

++

+

(+)

0

-

-

-

-

10

+++

++

+

(+)

0

-

-

-

-

10

0

0

0

The mean response was computed as the quotient of the sum of the observed reactions and the number of the treated animals.

Interpretation of results:
other: not sensitising
Conclusions:
No sensitization effects were observed after 72 hours post challenge exposure. Hence, the test chemical can be considered as non -sensitizing to the female guinea pigs.
Executive summary:

Modified FCA method and Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical. 20 female Pirbright White guinea pigs were used for the study.

.In the induction phase, the test compound was dissolved in FCA, 15 mg in 4 ml physiological saline and an emulsion was prepared by mixing the material by mean of a 5ml syringe, until emulsification was completed. The intradermal injections of 6 X 0.10-0.15 ml of this emulsion was applied in a semi circle arc on clipped and shaved shoulder from left to right in such a way that whole quantity of emulsion was used up for 10 animals. This procedure was repeated on 5thand 9thday, leaving a gap of 2-3 cm between the rows of injection. After induction phase of 11 days, animals were challenged by applying 0.05ml of test chemical in a sub irritant concentration, with further dilution to the clipped and shaved skin of the right flank of the treated animals, allowing 5 mins for drying. Control animals were also used. Mean Observations were made after 24, 48 and 72 hours.

No sensitization effects were observed after 72 hours post challenge exposure. Hence, the test chemical can be considered as non -sensitizing to the female guinea pigs.

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

Various studies have been reviewed to evaluate the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies performed on guinea pigs, for the test chemical. The results are summarized below:

Modified FCA method and Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical. 20 female Pirbright White guinea pigs were used for the study.

In the induction phase, the test compound was dissolved in FCA, 15 mg in 4 ml physiological saline and an emulsion was prepared by mixing the material by mean of a 5ml syringe, until emulsification was completed. The intradermal injections of 6 X 0.10-0.15 ml of this emulsion was applied in a semi circle arc on clipped and shaved shoulder from left to right in such a way that whole quantity of emulsion was used up for 10 animals. This procedure was repeated on 5thand 9thday, leaving a gap of 2-3 cm between the rows of injection. After induction phase of 11 days, animals were challenged by applying 0.05ml of test chemical in a sub irritant concentration, with further dilution to the clipped and shaved skin of the right flank of the treated animals, allowing 5 mins for drying. Control animals were also used. Mean Observations were made after 24, 48 and 72 hours.

No sensitization effects were observed after 72 hours post challenge exposure. Hence, the test chemical can be considered as non -sensitizing to the female guinea pigs.

This result is supported by a study performed on guinea pigs to observe the skin sensitization effects of the test chemical. In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.

Since the test chemical failed to induce any cutaneous reaction at challenge concentrations in the test animals it was considered as not sensitizing to guinea pigs.

These results are further supported by another skin sensitization study performed on guinea pigs to observe the sensitization potential of the test chemical. The chemical did not produce any sensitization potential after challenge exposure on the guinea pigs .Thus, the test chemical can be considered to be not sensitizing to skin.

Available results for the test chemical indicate a possibility that the test chemical indeed lacks the potential to cause sensitizing reactions to the skin. Hence, it can be considered to be not sensitizing to skin. It can be further classified under the category "Not Classified" as per CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Available results for the test chemical indicate a possibility that the test chemical indeed lacks the potential to cause sensitizing reactions to the skin. Hence, it can be considered to be not sensitizing to skin. It can be further classified under the category "Not Classified" as per CLP Regulation.