Registration Dossier

Administrative data

Description of key information

New test on Ginger oil -selective extract is waived based on Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009)

Supporting study on Acute Oral Toxicity (OECD TG 401): LD50 > 5000 mg/kg bw (Ginger oil, type of extract not specified)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Data waiving:
study waived due to provisions of other regulation
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Attached to this record is provided a statement in which the registrant declares the sole cosmetic use of this substance.
Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009) establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the EU finished cosmetic products and ingredients included in cosmetic products which were tested on animals for cosmetics purposes (marketing ban). A testing ban on finished cosmetic products applies since 11 September 2004; a testing ban on cosmetic ingredients or combination of ingredients applies since 11 March 2009. A marketing ban for products containing ingredients tested outside the EU applies since 11 March 2013, irrespective of the availability of alternative non-animal tests. In general terms, the provisions of the REACH apply to substances and preparations used in cosmetic products. However, REACH shall apply without prejudice to the CR as regards testing involving vertebrate animals within the scope of the CR (Article 2/4/b). Moreover, the above statement is confirmed by ECHA in the “Interface between REACH and Cosmetics regulations 2014a” factsheet (ECHA-14-FS-04-EN). Knowing that the test substance (Ginger -selective extract) is only and exclusively used in the formulation for cosmetic purposes, no animal testing is possible toassess the acute oral toxicity endpoint, and therefore this in vivo study is not conducted.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
May 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented pre-guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
- five male and five female albino rats of the Sherman-Wistar strain - The animals were starved for 24 hours before dosing.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24 hours
- Diet (e.g. ad libitum): ad libitum after exposure
- Water (e.g. ad libitum): ad libitum after exposure
- Acclimation period: 7 days
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Mild signs of morbidity soon after dose administration.
Full recovery 24 hours later.
Interpretation of results:
other: not classified
Remarks:
based on CLP criteria (Annex I of 1272/2008/EC)
Conclusions:
The oral LD50 value of Ginger oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex I of the CLP Regulation 1272/2008/EC.
Executive summary:

Ginger oil was evaluated for acute oral toxicity in rats in a study similar to OECD TG 401. Two groups, consisting of five male and five female albino rats of the Sherman-Wistar strain, were set aside and observed for a period of one week for acclimatisation. The animals were then starved for 24 hours. Doses at 5000 mg/kg bw were administered by means of a syringe and stomach tube. Following this, the animals were allowed food and water ad libitum during a fourteen-day observation period. No mortality occurred, mild signs of morbidity soon after dose administration. The treated rats recovered fully 24 hours later. The oral LD50 value of Ginger oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study.

The substance therefore does not have to be classified for acute oral toxicity according to the classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Study is used as supporting information, since Ginger oil was tested in a well conducted study but the type of extract was not specified

Additional information

As no new tests can be performed on Ginger oil - selective extract under Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009). The endpoint was evaluated using the available acute toxicity data for ginger oil (type of extract not specified).

Waiver

Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009) establishes a prohibition to test finished cosmetic products and cosmetic ingredients on animals (testing ban), and a prohibition to market in the EU finished cosmetic products and ingredients included in cosmetic products which were tested on animals for cosmetics purposes (marketing ban). A testing ban on finished cosmetic products applies since 11 September 2004; a testing ban on cosmetic ingredients or combination of ingredients applies since 11 March 2009. A marketing ban for products containing ingredients tested outside the EU applies since 11 March 2013, irrespective of the availability of alternative non-animal tests. In general terms, the provisions of the REACH apply to substances and preparations used in cosmetic products. However, REACH shall apply without prejudice to the CR as regards testing involving vertebrate animals within the scope of the CR (Article 2/4/b). Moreover, the above statement is confirmed by ECHA in the “Interface between REACH and Cosmetics regulations 2014a” factsheet (ECHA-14-FS-04-EN).  Knowing that the test substance (Ginger -selective extract) is only and exclusively used in the formulation for cosmetic purposes, no animal testing is possible to assess the acute oral toxicity endpoint, and therefore this  in vivo study is not conducted.

Supporting Acute Oral Toxicity (Ginger oil, type of extract not specified)

Ginger oil was evaluated for acute oral toxicity in rats in a study similar to OECD TG 401. Two groups, consisting of five male and five female albino rats of the Sherman-Wistar strain, were set aside and observed for a period of one week for acclimatisation. The animals were then starved for 24 hours. Doses at 5000 mg/kg bw were administered by means of a syringe and stomach tube. Following this, the animals were allowed food and water ad libitum during a fourteen-day observation period. No mortality occurred, mild signs of morbidity soon after dose administration. The treated rats recovered fully 24 hours later. The oral LD50 value of Ginger oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. Based on the results of the available acute toxicity test for Ginger oil, no toxicity of ginger extracts is expected.

Justification for classification or non-classification

As no new tests can be performed on Ginger oil - selective extract under Article 18 of the Cosmetics Regulation (CR, EC No 1223/2009). The endpoint was therefore evaluated using the only available acute toxicity data for ginger oil (type of extract not specified). Based on the results of the acute toxicity test the substance Ginger CO2 -SE extract therefore is not classified according to the classification criteria outlined in  Annex I of the CLP Regulation 1272/2008/EC.