Registration Dossier
Registration Dossier
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EC number: 700-868-7 | CAS number: 54889-63-3
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: OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- (1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane
- EC Number:
- 700-868-7
- Cas Number:
- 54889-63-3
- Molecular formula:
- C12 H24 O2
- IUPAC Name:
- (1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): Cyclohexane, 1,4-bis(ethoxymethyl)-
- Physical state: Liquid
- Analytical purity: 99.6 corrected area-%
- Batch No.: 10474-11-115
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- pH-value: ca. 5 (undiluted test substance)
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- 50 μL (corrosion test) or 30 μL (irritation test)
- Duration of treatment / exposure:
- 3 minutes and 1 hour (corrosion test)
1 hour followed by 42 hours post-incubation period (irritation test) - Observation period:
- 3 minutes and 1 hour (corrosion test)
1 hour with 42 hours postincubation (irritation test) - Number of animals:
- not applicable
- Details on study design:
- For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed
by a 42-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
Negative control: de-ionized water (corrosion test); PBS, sterile (irritation test)
Positive control: 8-n KOH (corrosion test); 5% (w/v) SDS in sterile water (irritation test)
Number of tissues used: 2 per exposure period (corrosion test); 3 (irritation test)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 91
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Corrosion Test
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 113
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Corrosion Test
- Irritation parameter:
- other: tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour + 42 hours postincubation
- Score:
- 9
- Reversibility:
- other: not applicable
- Remarks on result:
- other: % viability of negative control; Irritation Test
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Conclusions:
- The present data on skin irritation do fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a classification "irritating to skin" (R38) and "skin irritant" (category 2) is warranted.
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