Registration Dossier
Registration Dossier
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EC number: 232-313-5 | CAS number: 8002-53-7 Wax obtained by extraction of lignite.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD test guideline 431 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD test guideline 431
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Draft guideline: In vitro Skin irritation: Reconstituted Human Epidermis (Rhe) Test Method
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Montan wax
- EC Number:
- 232-313-5
- EC Name:
- Montan wax
- Cas Number:
- 8002-53-7
- Molecular formula:
- As montan wax is a UVCB, a molecular formular cannot be specified.
- IUPAC Name:
- Montan wax
Constituent 1
Test animals
- Species:
- other: EpiDerm skin model
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative and positive controls were included
- Amount / concentration applied:
- 25.6 to 25.9 mg per tissue
- Duration of treatment / exposure:
- 60 minutes
- Observation period:
- 42 hours incubation time
- Number of animals:
- not applicable
- Details on study design:
- Three tissues were used. Tissues were wetted with 25µl DPBS before application
Results and discussion
In vivo
Results
- Irritation parameter:
- other: cell viability
- Basis:
- mean
- Time point:
- other: not applicable
- Score:
- 110.8
- Reversibility:
- other: not applicable
- Remarks on result:
- other: score is % viability
Any other information on results incl. tables
All test acceptance criteria (absolute response of the negative control, realtive response of the positive control and variability between replicate measurements) were met.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a GLP study according to the OECD draft guideline 'In vitro Skin irritation: Reconstituted Human Epidermis (Rhe) Test Method' using the in vitro EpiDerm model, the test substance is considered as not irritating.
- Executive summary:
Based on the results of a GLP study according to the OECD draft guideline 'In vitro Skin irritation: Reconstituted Human Epidermis (Rhe) Test Method' using the in vitro EpiDerm model, the test substance is considered as not irritating as it did not reduce cell viability and as all accpetance criteria were met.
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