Registration Dossier
Registration Dossier
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EC number: 203-931-2 | CAS number: 112-05-0
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1961
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- acute dermal toxicity test
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- not stated
- Doses:
- maximum dose: 5 g/kg bw, other doses not stated
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the LD50 was > 5 g/kg bw.
- Executive summary:
The dermal LD50 in rabbits was > 5 g/kg bw (no further details stated; Opdyke, 1978).
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human maximisation test
- GLP compliance:
- not specified
- Type of population:
- general
- Controls:
- no data
- Route of administration:
- dermal
- Conclusions:
- Data reported in the secondary source are insufficient for assessment.
- Executive summary:
A human maximisation test was performed using 25 volunteers. The test item (purity not stated) was applied at a concentration of 12% in petrolatum. After induction (5 times patch application for 48 h) and challenge (14 days after induction, once for 48 h) exposures the summary stated that the test item produced no sensitisation reactions (Opdyke, 1978).
Reading |
1st reading |
Hours after challenge |
72 |
Group |
test group |
Dose level |
12% in petrolatum |
No. with + reactions |
|
Total no. in group |
25 |
Clinical observations |
no sensitisation occured |
Reading |
2nd reading |
Hours after challenge |
96 |
Group |
test group |
Dose level |
12% in petrolatum |
No. with + reactions |
|
Total no. in group |
25 |
Clinical observations |
no sensitisation occured |
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- acute parenteral toxicity test
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Pelargonic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: 2-% emulsion based on cottonseed oil, emulsifier and buffer
- 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:
- LC50
- Effect level:
- 244 mg/kg bw
- Remarks on result:
- other: i.v. application
Any other information on results incl. tables
The animals exhibited convulsions and collapse followed by respiratory arrest within 2 min.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the i.v. LD50 in mice was 244 mg/kg bw.
- Executive summary:
The i.v. LD50 in mice was 244 mg/kg bw. The animals exhibited convulsions and collapse followed by respiratory arrest within 2 minutes (Opdyke, 1978).
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