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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Draize, J.H. Dermal Toxicity. Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics. 46-59; 1959
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Buehler, E.V. Delayed contact hypertensensitivity in the guinea pigs. Arch. Dermat. 91:171-175; 1965
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed in 1980

Test material

Constituent 1
Chemical structure
Reference substance name:
Ruscus aculeatus, ext.
EC Number:
281-682-9
EC Name:
Ruscus aculeatus, ext.
Cas Number:
84012-38-4
Molecular formula:
not applicable
IUPAC Name:
Ruscus aculeatus, ext.
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
50% (w/v)
Day(s)/duration:
24
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#10
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
50% (w/v)
Day(s)/duration:
2
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.15% (w/v)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.15% (w/v)
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
Clinical observations.
No deaths occurred and all animals appeared normal throughout the study
Dermal responses
Individual dermal responses at 24 and 48 hours after administration of the challenge dose. For both group of animals treated with Rusco (induction plus challenge application and challenge application only) no erythema or edema was noted at 24 and 48 hours after administration of the challenge dose. Among the ten animals received the challenge dose of DNCB (1-chloro-2,4-dinitrobenzene Lot N° D9A, very slight erythema was noted in one animal at 24 hours while no dermal reaction were seen at 48 hours postdose. Among the ten animals exposed to both the induction and challenge doses of DNCB, very slight to well defined erythema was noted in all animals at 48 hours and in all but one animal at 48 hours following application of the challenge dose. No edema was noted in any animals exposed to DNCB. Because no delayed hypersensitization was noted in the animals exposed to Rusco, the test material was not considered a sensitizing agent in guinea pigs.