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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 264-120-7 | CAS number: 63393-96-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 Oct - 24 Oct 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD) with some divations, since the test substance was not characterized in detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- directive 84/449/EWG, 19. Sept, 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- EC Number:
- 264-120-7
- EC Name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- Cas Number:
- 63393-96-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides
- Details on test material:
- - Physical state: yellow brownish, oily liquid
- Analytical purity: not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 10-11 months
- Weight at study initiation: mean: 2550 g
- Housing: single in rabbit batteries
- Diet: Altromin Haltungsdiät 2023, Fa. Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least a week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
reading time points: 1, 24, 48, 72 hours, 7, 14 and 21 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the back
- Type of wrap if used: air and water vapor permeable paving fixed with a hypoallergen bandage
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: scabs were seen at application site starting at 24 hours
- Irritant / corrosive response data:
- Severe redness (score 3-4) and edema (score 3-4) were observed up to the 72 hour reading time point. Effects were not completely reversible until Day 21 and on Day 21 at the end of the observation period one animal still showed erythema (score 3) and the other 2 animals slight erythema (score 1). No edema was seen anymore but all animals showed scar tissue.
- Other effects:
- Scabs were also seen already 24 hours after removal of the test substance. Additionally brownish coloring of the application site was observed at the 72 h reading time point. At Day 21 all animals showed scabs and scar tissue.
Any other information on results incl. tables
Table 1. Results of skin irritation study.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
4 |
3 |
3 |
3 |
3 |
3 |
24 h |
4 |
3S |
3 |
3S |
4 |
3S |
48 h |
4 |
3S |
4 |
3S |
4 |
3S |
72 h |
4b |
3S |
4b |
3S |
4b |
3S |
21 days |
3 |
0S |
1 |
0S |
1 |
0S |
Mean value 24 + 48 + 72 h |
4 |
3 |
3.67 |
3 |
4 |
3 |
Mean value 24 + 48 + 72 h all animals |
3.89 |
3 |
|
|
|
|
S = scabs, b = brownish staining
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Conclusions:
- DSD: C, R34
CLP: Category 1C, H314
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.
