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Administrative data

Description of key information

The test item showed no skin senitisation potential in an in vivo study in guinea pigs (reference 7.4.1-1).

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
Study period:
not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6 (GPMT)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
No LLNA study was conducted as an in vivo study according was available before the first version of the LLNA (OECD 429) was issued in 2002.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No further information provided in SNIF.
Route:
intradermal
Vehicle:
other: distilled water and distilled water with Freuds adjuvance (1:1)
Concentration / amount:
5 %
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
50 %
No.:
#1
Route:
other: No further information provided in SNIF.
Vehicle:
water
Concentration / amount:
25 and 50 %
No. of animals per dose:
10 animals in test group and 5 in negative control group
Details on study design:
Pretreatment for topical induction exposure: 10 % w/v sodium-dodecyl-sulfate was applied.
No further information provided in SNIF.
Challenge controls:
No further information provided in SNIF.
Positive control substance(s):
no
Positive control results:
Not conducted.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Group:
positive control
Remarks on result:
other: No positive control was conducted.

SKIN REACTIONS OBSERVED AFTER INTRADERMAL INDUCTION:

Well-defined or moderate to severe erythema was noted at the intradermal induction sites of all test group animals at the 24-hour observation with very slight erythema a the 48-hour observation.

Very slight erythema was noted at the intradermal induction sites of three control animals at the 24-hour observation.

No skin reaction were noted at the intradermal induction sites of control group animals at the 48-hour observation.

 

SKIN REAKTIONS OBSERVED AFTER TOPCAL INDUCTION:

Very slight to well-defined erythema and very slight oedema were noted at the induction sites of all test group animals at the 1-hour observation.

Very slight erythema was noted at the induction sites of 4 test group animals at the 24-hour observation.

Other skin reactions noted in test group animals were bleeding from injection sites and desquamation.

Very slight to well-defined erythema and very slight oedema were noted at the treatment sites of all control group animals at the 1-hour observation.

Very slight erythema, with or without very slight oedema, was noted at the treatment sites of 4 control group animals at the 24-hour observation.

Other skin reactions noted in control group animals were bleeding from injection sites and desquamation.

 

Other observations:

Bodyweight gains of animals in the test group, between day 0 and day 24, were comparable to those observed in the control group animals over the same period.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no skin senitisation potential in an in vivo study in guinea pigs.
Executive summary:

A study was performed to assess the skin sensitisation potential of the test material using guinea pigs. The method used followed the recommendations of 92/69/EWG, B.6 (GPMT). Intradermal induction was done with 5 % test material in distilled water and distilled water with Freuds adjuvant (1:1). A topical induction with 50 % test item concentration was done. The challenge was performed with test item concentrations of 25 and 50 %. For each test item treatment group 10 animals were used. Furthermore, negative control groups were included with each 5 animals. After inductions slight erythema and oedema were observed in animals treated with the test item or the negative control. Both at the first and second reading after the challenge no positive reactions were observed in any of the test item treated animals or control animals, independent of the concentration. The test material is therefore considered to be no skin sensitizer.

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

A study was performed to assess the skin sensitisation potential of the test material using guinea pigs. The method used followed the recommendations of 92/69/EWG, B.6 (GPMT). Intradermal induction was done with 5 % test material in distilled water and distilled water with Freuds adjuvant (1:1). A topical induction with 50 % test item concentration was done. The challenge was performed with test item concentrations of 25 and 50 %. For each test item treatment group 10 animals were used. Furthermore, negative control groups were included with each 5 animals. After inductions slight erythema and oedema were observed in animals treated with the test item or the negative control. Both at the first and second reading after the challenge no positive reactions were observed in any of the test item treated animals or control animals, independent of the concentration. The test material is therefore considered to be no skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item does not require classification for causing skin sensitisation according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.