Registration Dossier
Registration Dossier
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EC number: 239-914-1 | CAS number: 15816-71-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- read-across from hydrolysis product
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) is hydrolytically very unstable so that in aqueous solution a rapid decomposition to the educts can be observed.The substance will rapidly dissociate to octanoic acid and dicyclohexylamine. Therefore Octanoic acid, compound with dicyclohexylamine (1:1) is not stable at “standard” testing conditions representative for human and environmental exposure. Hence, it is fully justified to apply the read-across methodology by use of the respective data from the breakdown/decomposition products to describe the (eco)toxicological behaviour of the substance to be registered.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: octanoic acid, dicyclohexylamine
Target: Octanoic acid, compound with dicyclohexylamine (1:1)
3. ANALOGUE APPROACH JUSTIFICATION
The corresponding breakdown products of Octanoic acid, compound with dicyclohexylamine (1:1) were identified by Ultra Performance Liquid Chromatography - tandem Mass Spectrometer (UPLC-MS) as Octanoic acid and Dicyclohexylamine.
Further evaluation of the hydrolysis time demonstrated that in aqueous solution the decomposition time is smaller than 8 minutes.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: literature data
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- polyethylene glycol
- Duration of exposure:
- 24 hours
- Doses:
- not specified
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- Reversible
skin irritation in all animals, moderate sedation, deep respiration, hunched posture - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).
- Executive summary:
The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).
Data source
Materials and methods
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Octanoic acid, compound with dicyclohexylamine (1:1)
- EC Number:
- 239-914-1
- EC Name:
- Octanoic acid, compound with dicyclohexylamine (1:1)
- Cas Number:
- 15816-71-4
- Molecular formula:
- C20H39NO2
- IUPAC Name:
- octanoic acid, compound with dicyclohexylamine (1:1)
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- polyethylene glycol
- Duration of exposure:
- 24 hours
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- Reversible
skin irritation in all animals, moderate sedation, deep respiration, hunched posture
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).
- Executive summary:
The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw).
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