Registration Dossier
Registration Dossier
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EC number: 203-629-0 | CAS number: 108-91-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: this study cannot be used for evaluation purposes due to the high concentration involved and the lack of relevant documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the toxicity and skin effects of compounds used in the rubber and plastics industries
- Author:
- Mallette, F. S.; von Haam, E.
- Year:
- 1 952
- Bibliographic source:
- A.M.A. Arch. Ind. Hyg. Occup. Med. 5, 311 - 317
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Not less than 15 individuals; TS was placed by patch on the skin of the back and remained for 48 hours. A diluted product was applied. The sensitizing effect was determined by reapplying the material to the skin after a waiting period of 14 days
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohexylamine
- EC Number:
- 203-629-0
- EC Name:
- Cyclohexylamine
- Cas Number:
- 108-91-8
- Molecular formula:
- C6H13N
- IUPAC Name:
- cyclohexanamine
- Details on test material:
- diluted (25 %); no further data
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: not less than 15
- Clinical history:
- no data
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- Not less than 15 individuals; TS was placed by patch on the skin of the back and remained for 48 hours. A diluted product was applied. The sensitizing effect was determined by reapplying the material to the skin after a waiting period of 14 days.
The reactions are read as negative, light, moderate, or severe.
Light reaction consists of a faint pinkish discoloration of the skin with slight scaling at late observation
Moderate reaction consistsof a dull red discoloration with edema, slight maceration, and possibly petechiae.
a severe reacttion consists of a painful , hemorrhagic inflammatory reaction followed by central necrosis and ulceration
Results and discussion
- Results of examinations:
- RM-Freetext: A slightly sensitizing effect was determined.
Reactions: faint pinkish discoloration of the skin with slight scaling
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
