Registration Dossier
Registration Dossier
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EC number: 412-570-1 | CAS number: 119462-56-5 PERKALINK 900
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- A single semi-occlusive application of 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene to intact rabbit skin for 4 hours was conducted.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- EC Number:
- 412-570-1
- EC Name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- Cas Number:
- 119462-56-5
- Molecular formula:
- Hill formula: C18 H16 N2 O4
- IUPAC Name:
- 3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
- Details on test material:
- - Name of test material (as cited in study report): m-xylylene bis(citraconimide)
Batch no.: BOM pp2
Purity: 87± 3% (m/m); see CoA attached
Other: m-Xylylene bis(itaconimide) 2-5%
appearance: brown powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 days
- Number of animals:
- 3 animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Because the test substance did not induce skin irritation, no classification is needed.
- Executive summary:
In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be not irritating to rabbit skin. No relevant systemic intolerance reactions were observed.
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