Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431 and 439
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trans-tilidin Oxalat, Erstabtrennung
- Test substance No: 10/0345-1
- Homogeneity: The test substance was homogenous by visual inspection.
- Analytical purity: > 99.5%
- Purity test date: > 99.5%
- batch No.: LV 8/10
- Storage condition of test material: The stability under storage conditions over the study period was guarenteed by the sponsor, and the sponsor
holds this responsibility.
- Other: pH-value: ca. 3 (undiluted test substance, moistened with water)

Test animals

Species:
other: Three dimensional human epidermis model
Strain:
other: in vitro method
Details on test animals and environmental conditions:
TEST SYSTEM

Three dimensional human epidermis model

The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.

Tissue model: Epi-200 Origin: MatTek Corporation, Ashland MA, USA

Based on the results of ECVAM (European Center for Validation of Alternative Methods) funded validation studies, it was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as
between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov 2008).

Test system

Type of coverage:
other: in vitro test
Preparation of test site:
other: in vitro test
Duration of treatment / exposure:
3 min up to 1 hour
Number of animals:
in vitro tset

Results and discussion

Any other information on results incl. tables

For details on results see below: "Overall remarks, attachments".

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the observed results and applying the evaluation criteria it was concluded, that trans-tilidin-Oxalat, Erstabtrennung does not show a skin irritation potential in the EpiDerm skin corrosion/irritation test under the conditions chosen.