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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:
02 May 1994 - 10 June 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was unkown in 1994

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
intradermal injection at 5%w/w in water
Day(s)/duration:
once
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
topical application at 50%w/w in water
Day(s)/duration:
1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
topical challenge at 50, 25, 10, 5%w/w in water
Day(s)/duration:
1
Adequacy of induction:
other: challenge
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
topical challenge at 50, 25, 10, 5%w/w in water
Day(s)/duration:
1
Adequacy of challenge:
not specified
No. of animals per dose:
4 per challenge dose
Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
Positive control experiment: Notox 108258 (January 1994) with Formaldehyd (37%): intradermal 0.38%w/w in water; epidermal 0.38%w/w in water; challenge 0.2% in water

Results and discussion

Positive control results:
maximum sensitisation rate: 70% in the experimental group.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no treatment related adverse effects
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
no treatment related adverse effects
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.2% Formaldehyd 37%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
maximum sensitisation rate: 5% in the experimental group (50% challenge concentraion).
PR-1577 has weak sensitising properties in this test applying the rating of allergenicity described by Kligman AM (1966).
Based on the criteria of EEC Directive 91/325/EEC, Amendment to Annex VI of EEC DIrective 67/548/EEC PR-1577 need not be labelled as a skin sensitiser.
GHS/CLP criteria are not met.