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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
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed prior to the LLNA test method availabllity.

Test material

Constituent 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: sesame oil
Concentration / amount:
5% intradermal / 25% epicutaneous
Day(s)/duration:
Intradermal induction on day 0, Epicutaneous induction on day 8 for 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
25%
Day(s)/duration:
On day 22 / for 24h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test group: 10
controll group 5
Details on study design:
according to guideline
Challenge controls:
according to guideline
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The registration substance was investigated for its skin sensitization property according to the OECD Guideline 406. No indication of skin sensitization was found.
Executive summary:

The registration substance was investigated for its skin sensitization property according to the OECD Guideline 406. Ten female guinea pigs were treated on day 0 intradermally at concentration of 5% and on day 8 epicutaneously using occlusive patch at concentration of 25% for 48 hours. Freund's Adjuvant were used for the intradermal induction to cause irritation effects. Five anmals were treated with vehicles only. On day 22 the treated as well as the only vehicle treated animals were treated epicutaneously using occlusive patch for 24 hours and the skin response was observed 24 and 48 hours after removal of patch. None of the treated and the vehicle only treated animals exhibited any indication of skin sensitization. The registration substance is a non-skin sensitizer.