Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-669-5 | CAS number: 590-01-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG 404 and the report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- Butyl propionate
- EC Number:
- 209-669-5
- EC Name:
- Butyl propionate
- Cas Number:
- 590-01-2
- Molecular formula:
- C7H14O2
- IUPAC Name:
- butyl propanoate
- Details on test material:
- - Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: assumed to be adults
- Weight at study initiation: no information available
- Fasting period before study: fasted overnight before dosing
- Housing: assumed to be individually housed
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4-hour
- Observation period:
- 7-14 days
- Number of animals:
- 6 rabbits
- Details on study design:
- 0.5 ml of UCAR n-butyl propionate was applied to the clipped intact skin under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Irritant / corrosive response data:
- There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate
- Other effects:
- One rabbit was found dead on day 7 with no evidence of this being related to the treatment.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.
- Executive summary:
In this study, 0.5 ml of UCAR n-butyl propionate was topically applied to the clipped intact skin (trunk) of 3 male and 3 female New Zealand White rabbits, under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application. There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate. An incidental mortality unrelated to the exposure of one male rabbit on day 7 was noted.
Under the conditions of the study, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.
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.
