Registration Dossier
Registration Dossier
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EC number: 203-233-8 | CAS number: 104-75-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- An acute dermal toxicity study does not need to be conducted as the test item is considered to be highly corrosive to skin (Skin Corrosion Category 1A, H314).
From a secondary source publication a dermal LD50 of 600 mg/kg bw was reported (RTECS entry 1978; reliability score: 4). A more recent specification in RTECS says 600 µL/kg bw = 474 mg/kg bw. However, this study was conducted using 'rabbit' as test species. The rabbit is the preferable laboratory animal for testing of dermal corrosivity (highly sensitive in terms of corrosive effects). But the highly sensitive rabbit is not the appropriate species for acute dermal toxicity testing using corrosive substances. In the RTECS entry no details on methodology, study design, exposure duration etc. are given. In the dermal corrosivity study necrosis was observed within 30 min post exposure (exposure duration 3 min). Thus, it is unclear if death of rabbits was due to systemic toxicity of the test substance following dermal administration, or due to a stress response to the severe local effects (destroyed skin tissue as corrosion response), and in addition, if damage of the skin facilitated increased systemic exposure to the substance. Further, 2-Ethylhexylamine is classified as acute toxic via the oral route category 4. A retrospective analysis of data from acute oral and dermal toxicity testing, performed on pesticide active substances and new chemical entities submitted for the Notification of New Substances Regulations (a total of 240 substances), has demonstrated that there is a relationship between dermal acute toxicity and oral acute toxicity, and there are no significant numbers of compounds that are classified as a potential hazard only via the dermal route (Creton et al. 2010: Acute toxicity testing of chemicals - Opportunities to avoid redundant testing and use alternative approaches. Critical Reviews in Toxicology; 40(1), 50-83).
In conclusion, because the existing piece of information is not assignable and the available data a derived from an unappropriate test species 2-Ethylhexylamine will not be classified for acute dermal toxicity.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- 1-Hexanamine, 2-ethyl-
- Author:
- ChemIDplus
- Year:
- 2 005
- Bibliographic source:
- ChemIDplus (2005): 1-Hexanamine, 2-ethyl- [CAS No. 104-75-6]. Nat. Library of Medicine
- Reference Type:
- secondary source
- Title:
- 2-Ethylhexylamin
- Author:
- GESTIS
- Year:
- 2 005
- Bibliographic source:
- Stoffdatenbank, Gefahrstoffinformationssystem der gewerblichen Berufsgenossenschaften
- Reference Type:
- secondary source
- Title:
- Hexylamine, 2-ethyl
- Author:
- RTECS
- Year:
- 1 978
- Bibliographic source:
- Hexylamine, 2-ethyl. Registry of Toxic Effects of Chemical Substances
Materials and methods
- Principles of method if other than guideline:
- Method: no data
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethylhexylamine
- EC Number:
- 203-233-8
- EC Name:
- 2-ethylhexylamine
- Cas Number:
- 104-75-6
- Molecular formula:
- C8H19N
- IUPAC Name:
- 2-ethylhexylamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 600 mg/kg bw
- Remarks on result:
- other: More recent specifications in RTECS say 600 µL/kg bw = 474 mg/kg bw
- Mortality:
- no data
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
Any other information on results incl. tables
More recent specifications in RTECS say 600 µL/kg bw = 474 mg/kg bw: see also GESTIS 2005 and ChemIDplus 2005.
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.
