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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: SCCS/1511/13
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Title:
Scientific Committee on Consumer Safety Opinion on Lawsonia Inermis (Henna) Colipa no C169
Author:
SCCS
Year:
2013
Bibliographic source:
ISBN 978-92-79-30118-6
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Using available in vivo data. LLNA- method was not available in 1990.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lawsonia inermis, ext.
EC Number:
284-854-1
EC Name:
Lawsonia inermis, ext.
Cas Number:
84988-66-9
Molecular formula:
na
IUPAC Name:
Lawsonia inermis, ext.
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Guideline:OECD 406
Species/strain:
Guinea pig/Dunkin Hartley
Group size:
Main study: 10 female animals in the control, 20 female animals in the test groups
Test substance: Henna Rot , Lawsonia Inermis Leaf Powder
Batch: 830.72
Purity: /
Route: Occlusive epicutaneous induction (50%) and challenge (50%)
Carrier: Petrolatum
GLP: Yes
Date: 1990

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
One group of 20 animals received induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair. The occlusive dressing was kept in place for 6 hours and the induction was repeated on the same site on days 7 and 14 for a total of three 6 h exposures. The skin was carefully examined approximately 24 h after each induction on days 1, 8 and 15.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left
flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair.
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 ml test material (50% in petrolatum)
Adequacy of challenge:
not specified
No. of animals per dose:
20
Details on study design:
The sensitizing property of the test substance was evaluated in a Buehler delayed contact hypersensitivity study using female albino Hartley guinea pigs. One group of 20 animals received induction exposures of 0.5 ml at a concentration of 50% in petrolatum on the left flank on absorbent lint (approximately 15 mm x 35 mm) after removal of hair. The occlusive dressing was kept in place for 6 hours and the induction was repeated on the same site on days 7 and 14 for a total of three 6 h exposures. The skin was carefully examined approximately 24 h after each induction on days 1, 8 and 15.
Challenge was performed on day 28 by application of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm on the right left flank clipped free of hair held under occlusion for 6 h. Approximately 24 and 48 h after removal of the occlusive dressing, the skin reaction was evaluated and scored using a four-point scale. The individual reactions to the tests substance preparation at the challenge sites were compared between control and test animals.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
not specified

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Challenge was performed on day 28 by applic ation of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm on the right left flank clipped free of hair held under occlusion for 6 h.
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge was performed on day 28 by applic ation of 0.5 ml test material (50% in petrolatum) on an area of about 15 mm x 30 mm
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Staining caused by the test substance preparation was observed after removal of the occlusive dressing. The study authors considered that this did not prevent evaluation of the treated skin in respect to erythema formation. No treatment-related reaction was noted on the treated skin in any animals (0/20)
The results suggest that Lawsonia inermis exhibited no potential to induce dermal sensitization in Guinea pigs in the Buehler test under the conditions used. However, skin staining may have compromised evaluation.