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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
OECD Guideline for Testing of Chemicals No. 406 "Sikn Sensitisation" (17 July 1992)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Due to the substance's high insolubility in water and the LLNA test method limitations, it is difficult to evaluate whether a LLNA result would be applicable.

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Molecular weight: 455.55
Appearance: light yellow powder
Purity: 98.69%
Storage condition: room temperature (1-30 degree C)
Storage and handling: keep away from ignition sources; avoid contact with eyes and prolonged or repeated skin contact; avoid continuous or repetitive breathing of dust.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Quarantine and acclimation: Animal physical condition and record of health monitoring were checked at the day of animal receipt. Animals were acclimated for 12 days. Only animals with the best appearance were selected for the test after observation during the acclimation period.
Number of used animals: 5 animals for pilot test and 30 animals for main test.
Grouping: animals were weighted one day before the administratin and animals over 300 g were randomly assigned to the test or control groups.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Intradermal induction dose was 1% (w/v), topical induction dose was 20%(w/v) and challenge dose was 5%(w/v)
Day(s)/duration:
skin sensitisation was evaluated by observing clinical signs and skin reactions at 24 hours and 48 hours after removal of challenge patch.
No. of animals per dose:
Number of animals in treated group: 20 (female)
Number of animals in vehicle control: 10 (female)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
intradermal induction dose 1%, topical induction dose 20%, challenge dose 5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
No clinical signs and mortalities related to the application of the test substance during this study.
Remarks on result:
other: see remarks
Remarks:
sensitisation rate of 5% at 24 hours after removal of challenge patech.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
intradermal induction dose 1%, topical induction dose 20%, challenge dose 5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
No clinical signs and mortalities related to the application of the test substance during this study.
Remarks on result:
other: see remarks
Remarks:
sensitisation rate of 5% at 48 hours after removal of challenge patech.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
Vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs and mortalities related to the application of the test substance during this study.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle control
Dose level:
Vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs and mortalities related to the application of the test substance during this study.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no data
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no data
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no data
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
no data
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no data

Any other information on results incl. tables

Clinical signs and mortality: There was no clinical signs and mortalities related to the application of test substance during this study.

Body weight changes: There was no significant body weight change related to the application of test substance during this study.

Obervation of applied site

(1) Test substance treated group

As a result of observations at 24 hours after removal of challenge patch, score 2 skin reaction (Moderate and confluent erythema) was observed in 1 of 20 animals. In the case of 48 hours after removal of challenge patch, score 3 skin reaction (Intense erythema and swelling) was observed in 1 of 20 animals.

(2) Vehicle control

Skin reaction (edema or erythema) was not observed at 24, 48 hours after removal of challenge patch.

 

Determination of skin sensitisation

(1) In the case of test substance treated group, sensitisation rates were 5 % at 24, 48 hours after removal of challenge patch, respectively. Therefore, the final sensitisation rate of test substance was 5 % and the test substance was classified as “Weak” (Grade I) sensitizer according to “criteria for skin sensitisation”.

(2) In the case of vehicle control group, sensitisation rates were 0 % at both 24, 48 hours after removal of challenge patch. Therefore, the final sensitisation rate of vehicle was 0 % and vehicle was classified as “Weak” (Grade I) sensitiser according to “criteria for skin sensitisation”.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated as a non-sensitizing substance.
Executive summary:

The study was performed to evaluate the skin sensitisation of the test substance in 30 female guinea pigs by guinea pig maximisation test (GPMT) method. Corn-oil was used as the vehicle. Intradermal induction dose was 1% (w/v), topical induction dose was 20% (w/v) and challenge dose was 5%(w/v) for the test substance. Skin sensitisation was evaluated by oberving clinical signs and skin reactions at 24 hours and 48 hours after removal of challenge patch.

(1) There was no clinical signs and mortalities related to the applicaton of test substance during this study.

(2) There was no significant body weight change related to the application of test substance during this study.

(3) In the test substance treated group, sensitisation rate was 5% at 24 and 48 hours after removal of challenge patch. Therefore, the final sensitisation rate of test substance was 5%.

Based on the results decribed above, the sensitisation rate of the test substance was 5% and it was classifed "Weak" (Grade I) sensitizer. Therefore, the test substance was evaluated as a non-sensitizing substance.