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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: SCCS/1511/13
Adequacy of study:
key study
Study period:
not specified
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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml of the test substance (approximately 58 mg) was instilled into the conjunctival sac of the right eye
Duration of treatment / exposure:
The test substance was not washed out.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Guideline: OECD guideline 405 (1987)
Species/strain: Rabbit/New Zealand White
Group size: 1 male and 2 females
Test substance: Henna Rot ,Lawsonia Inermis Leaf Powder
Batch: 830.72
Concentration: green powder ‘as is’
Route: instillation in the conjunctival sac of the right eye
Observation period: 7 days
GLP: Yes

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
>= 17 - <= 17
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
>= 15.7 - <= 15.7
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
>= 10 - <= 10
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
>= 2.7 - <= 2.7
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
>= 0 - <= 0
Reversibility:
fully reversible
Other effects:
No findings of the cornea occurred. Transient inflammation of the iris and moderate conjunctival irritation were observed up to a maximum of 48 and 72 hours, respectively.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Lawsonia inermis was slightly and transiently irritating to the eyes of 3 New Zealand White rabbits. (Group size 3 rabbit)