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Description of key information

An acute oral toxicity study of Henna was performed in the Rat according to the OECD Guideline N°401 (1981).

The calculated oral median lethal dose was > 2000 mg/kg bw. Other studies support this result. The other oral toxicity study informs that LD50 is 2000mg/kg bw. And LD50 is 570 -2000mg/kg bw for active substance (Lawsone, HNQ)

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: SCCS/1511/13
Adequacy of study:
key study
Study period:
na
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
not specified
GLP compliance:
not specified
Test type:
other: not specified
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
not specified
Mortality:
Not specified
Clinical signs:
Not specified
Body weight:
Not specified
Interpretation of results:
GHS criteria not met
Conclusions:
The calculated oral median lethal dose was > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
A study was performed in rat according to the OECD Guideline N°401 (1981). Quality of database is acceptable.

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Version / remarks:
1987
GLP compliance:
not specified
Species:
rat
Strain:
Wistar
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24h
Doses:
not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal toxicity study of Henna Rot was conducted in the Wistar Rat according to OECD Guideline 402 (1987). Median lethal dose for Henna Rot was > 2000 mg/kg 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.
Endpoint:
acute toxicity: dermal
Type of information:
other: Journal of Advances in Biotechnology, 2016
Adequacy of study:
key study
Study period:
na
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
not specified
GLP compliance:
not specified
Specific details on test material used for the study:
Fresh whole plant samples were obtained from Jerantut, Pahang, Malaysia. The leaves were separated from the plant and dried at a temperature between 25°C to 30°C for three to five days. The dried leaves were ground into powder form using a grinder and kept in a refrigerator at 4°C. The powdered leaves were then macerated with 97% ethanol in a flask. The mixture was left in a water bath at temperature between 55°C to 60°C for one day to allow the chemicals in the leaves to dissolve in the ethanol solution. The ethanol phase was isolated from the mixture by filtration followed by evaporation using a rotor paper evaporator then dried using freeze dryer for one day. The diluted solutions were kept in the refrigerator for later use. The leaf extract was mixed with white soft paraffin (10%).
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
the rats were weighed and assigned randomly in polypropylene plastic cages, where one rat was placed in each cage with wood chips for bedding and housed in an animal room with controlled conditions involving these parameters; temperature (22±2°C), humidity (55±10%) and lighting (12 hours light/dark) in the animal house.
Vehicle:
paraffin oil
Duration of exposure:
The application of extract in acute toxicity study occurred once
Doses:
In acutedermal toxicity studies, the toxic effects of the ethanolic leaf extract of L. inermis in Sprague Dawley rats were examined at dosages of 2000 and 5000 mg/kg body weight for a period of 14 days for acute dermal toxicity study.
No. of animals per sex per dose:
20 /female
Control animals:
not specified
Details on study design:
The duration of this study was 14 days. Each group underwent application of the extract once at day 1 and sacrificed at day 14 of the experimental period.
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 5 000 - <= 5 000 mg/kg bw
Based on:
not specified
Mortality:
No mortality
Clinical signs:
In the treated groups, in the first 6 hours after applying the extract rapid heartbeat was observed, but then normalized. This may be due to the stress of handling.
Body weight:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study suggest that ethanolic extracts of L. inermis do not cause any apparent in vivo toxicity. No death or signs of toxicity were observed in rats treated with the extracts at doses of 5000 and 2000 mg/kg (acute toxicity study),
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
An acute dermal toxicity studies of Henna was conducted in the Rat according to OECD Guideline 402. Quality of database is acceptable.

Additional information

Justification for classification or non-classification

Acute oral toxicity studies; Median lethal dose for Henna Rot was > 2000 mg/kg bw.

Acute dermal toxcicity studies; MEdian lethal dose for Henna was 2000 -5000mg/kg bw.