Registration Dossier
Registration Dossier
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EC number: 220-278-9 | CAS number: 2698-41-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 009
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 13 April 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(2-chlorophenyl)methylene]malononitrile
- EC Number:
- 220-278-9
- EC Name:
- [(2-chlorophenyl)methylene]malononitrile
- Cas Number:
- 2698-41-1
- Molecular formula:
- C10H5ClN2
- IUPAC Name:
- [(2-chlorophenyl)methylene]malononitrile
- Reference substance name:
- 4-methylpentan-2-one
- EC Number:
- 203-550-1
- EC Name:
- 4-methylpentan-2-one
- Cas Number:
- 108-10-1
- Molecular formula:
- C6H12O
- IUPAC Name:
- 4-methylpentan-2-one
- Reference substance name:
- hexyl acetate
- Cas Number:
- 88230-35-7
- Molecular formula:
- C8H16O2
- IUPAC Name:
- hexyl acetate
- Reference substance name:
- Dimethyl glutarate
- EC Number:
- 214-277-2
- EC Name:
- Dimethyl glutarate
- Cas Number:
- 1119-40-0
- Molecular formula:
- C7H12O4
- IUPAC Name:
- dimethyl glutarate
- Reference substance name:
- unknown impurities
- Cas Number:
- Not applicable
- Molecular formula:
- Not applicable
- IUPAC Name:
- unknown impurities
Constituent 1
Constituent 2
Constituent 3
Constituent 4
impurity 1
- Specific details on test material used for the study:
- substance CS at 5 % in MBIK and hexyl acetate solvents used (no dimetyl glutarate as mentioned in test material)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermis cells
- Cell source:
- other: Not specified
- Source strain:
- other: human
- Details on test system:
- Episkin™ Reconstituted Human Epidermis Model
- Amount/concentration applied:
- 5% in solvents MBIK or hexyl acetate
- Duration of treatment / exposure:
- 3, 60, 240 minutes
- Duration of post-treatment incubation (if applicable):
- Not specified
- Number of replicates:
- Not specified
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 5% test material in hexyl acetate - exposure period 240 minutes
- Value:
- ca. 97.4
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 5% test material in MBIK - exposure period 240 minutes
- Value:
- ca. 97.4
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non corrosive
- Other effects / acceptance of results:
- relative mean viability for positive control was 7.3% relative to the negative control treated tissues following 240 minutes exposure period: validity criterion satisfied
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive.
- Executive summary:
According to study using Episkin Reconstituted Human Epidermis Model. which methodology follows OECD 431 standard, the results showed that the substance CS at 5% in either hexyl acetate or MIBK or dimethyl glutarate solutions is non-corrosive. The results were published by (Croft, 2003).
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