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Description of key information

Skin irritation study does not to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose. An acute dermal toxicity: Median lethal dose for Henna was > 2000 mg/kg bw, even 5000 mg/lkg bw. Lawsonia inermis showed no irritative potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity under the experimental conditions.

Lawsonia inermis was slightly and transiently irritating to the eyes of New Zealand White rabbit. Also active substance (Lawsone) is irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
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
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.
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)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Eye irritation (Classification category 2B): 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. When scored, according to the modified scoring systems, the mean values are 17.0; 15.7; 10.0; 2.7 and 0.0 after 1, 24, 48 and 72 hours and 7 days, respectively. The iris and conjunctival findings subsided completely after 7 days

Skin irritation: Acute dermal toxicity is over 2000 mg/kg bw. So lawsonia inermis is not corrosive/irritative.