Registration Dossier
Registration Dossier
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EC number: 603-894-6 | CAS number: 135108-88-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Adequacy of study:
- supporting study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: Exposure time differs from OECD guideline procedures.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. Department of Transportation
- Principles of method if other than guideline:
- Dermal exposure to rabbits, for 24 hours of occlusive exposure. Assessment of irritation according to Draize, Woodard and Calvery, 1944, at 24 and 48 hr after exposure.
- GLP compliance:
- no
- Remarks:
- precedes establishment of GLP
Test material
- Reference substance name:
- 4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 217-168-8
- EC Name:
- 4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 1761-71-3
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 4,4'-methylenedicyclohexanamine
- Test material form:
- liquid: viscous
- Details on test material:
- no data on test material. Monsanto Company, St. Louis, MO, 1966. Material is a liquid which is applied undiluted.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 1, 24, 48, 72, 120 and 168 hours
- Number of animals:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- other: Corrosive to skin after 24 h of occlusive exposure.
- Irritant / corrosive response data:
- Maximum irritation (8 of 8) occurs at 24 h and at all times afterwards. At one hour, a score of 5.6 (of 8 total) was observed, based non moderate redness and dema.
Applicant's summary and conclusion
- Conclusions:
- Formaldehyde, polymer with benzenamine, hydrogenated contains > 10% of the read-across substance PACM as low boiling products. PACM is determined to be corrosive in the rabbit by Acute Dermal Irritation.
Due to the nature of the substance Corrosivity can be anticipated.
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