Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 263-502-0 | CAS number: 62314-22-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Version / remarks:
- Section 173.240 (a) (1) Ti t l e 49 C F R
- Principles of method if other than guideline:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed. - GLP compliance:
- not specified
Test material
- Reference substance name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- EC Number:
- 263-502-0
- EC Name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- Cas Number:
- 62314-22-1
- Molecular formula:
- C8H15O2.C6H16NO
- IUPAC Name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- Reference substance name:
- Ethane-1,2-diol
- EC Number:
- 203-473-3
- EC Name:
- Ethane-1,2-diol
- Cas Number:
- 107-21-1
- Molecular formula:
- C2H6O2
- IUPAC Name:
- ethylene glycol
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
In vitro test system
- Control samples:
- no
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol.
- Duration of treatment / exposure:
- 4h
- Observation period:
- 4h/24h/72h
- Number of animals:
- 6
- Details on study design:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.83
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Imtact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits.
A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema. - Executive summary:
75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits. A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema.
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.
