Cyperus scariosus, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Q2/2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

not specified

Remarks:

The summary report only was received from data owner. No details on GLP compliance was provided. The data owner is requested to provide the full study report.

Test material

Test material information

Constituent 1

Reference substance name:

Cyperus scariosus, ext.

EC Number:

294-955-2

EC Name:

Cyperus scariosus, ext.

Cas Number:

91771-62-9

IUPAC Name:

Cyperus scariosus, ext.

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2141111

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

SkinEthic Skin Irritation Test-42bis adday

Duration of treatment / exposure:

42 hours

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

Three

Test system

Details on study design:

Each test substance (test material, negative and positive controls) is topically applied concurrently on three tissues replicates for 42 minutes at room temperature (RT, comprised between 18°C to 24°C). Exposure to the test substance was followed by rinsing with phosphate buffer saline (PBS) and mechanically dried. Epidermis were then transferred to fresh medium and incubated at 37°C for 42 additional hours. Cell viability is assessed by incubating the tissues for 3 hours with 0.3 mL MTT solution (1 mg/mL). The formazan crystals are extracted using 1.5 mL isopropanol for 2 hours at RT and quantified by spectrophotometry at 570 nm wavelength. Sodium Dodecyl Sulphate (SDS 5%), and PBS treated epidermis are used as positive and negative controls, respectively. For each treated tissue, the cell viability is expressed as the percentage of the mean negative control tissues. Values less than 50% is qualified the test substance as irritant.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

39.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Negative control (NC) acceptance criteria: The NC data meet the acceptance criteria if the mean OD value of the 3 tissues is ≥ 1.2 at 570 nm.
The Standard Deviation value is considered as valid if it is ≤ 18%, according to the Performance Standards (ECVAM SIVS, 2007).

Positive control (PC) acceptance criteria: The PC data meet the acceptance criteria if the mean viability, expressed as % of the NC, is < 40 % and the Standard Deviation value is ≤ 18 %.

Batch acceptance criteria: All test substance data from one batch are considered as valid if both the negative and the positive controls data fulfill the above criteria requirements.

Any other information on results incl. tables

OD 570 nm	Tissue 1			Tissue 2			Tissue 3			Mean	Mean Tissue Viability (%)	SD (%)	Conclusion
PBS (Negative control)	2,540	2,531	2,540	2,544	2,469	2,507	2,557	2,460	2,445	2,510	100	1,0	non irritant
SDS (Postive control)	0,024	0,024	0,024	0,025	0,024	0,023	0,024	0,025	0,024	0,024	1,0	0,0	irritant
Cyperus scariosis, ext.	0,817	0,812	0,815	1,443	1,359	1,374	0,812	0,754	0,774	0,996	39,7	13,7	irritant

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The SkinEthic Skin Irritation Test designed for the prediction of acute skin irritation of chemicals by measurement of its cytotoxic, as reflected in the MTT assay indicated cell viability of 39,7%. Based on the criteria for interpretation the test item, Cyperus scariosusm ext. is classified as irritant. According to CLP, substance is irritant, cat. 2.