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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 256-289-0 | CAS number: 46948-72-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-11-13 to 1984-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, guideline conform GLP study, which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-[methyl(phenylsulphonyl)amino]hexanoic acid
- EC Number:
- 256-289-0
- EC Name:
- 6-[methyl(phenylsulphonyl)amino]hexanoic acid
- Cas Number:
- 46948-72-5
- Molecular formula:
- C13H19NO4S
- IUPAC Name:
- 6-(N-methylbenzenesulfonamido)hexanoic acid
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: HOECHST AG, Kastengrund
- Weigth at study initiation: 2.0 - 2.8 kg
- Labeling: earmarks
- Housing: air-conditioned rooms; single cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS:
- Temperature: 20 +/- 3°C
- Humidity: 50 +/-20%
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.9 % (w/w) NaCl solution
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 500 mg test item per 0.4 mL of 0.9 %(w/w) NaCl solution - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- overall
- Time point:
- other: 30 - 60 min/24 h/48h/72H
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- overall
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 30-60 min/24 h/48 h/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No erythema and no edema reactions. No corrosive effects.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registration substance was not irritating to rabbit skin and is not subjected for labbeling requirements.
- Executive summary:
The primary skin irritation potential of the registration substance was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mg test material in 0.4 mL of 0.9 % (w/w) NaCl solution (in order to make the test item doughy). The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 -60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and oedema were evaluated numerically according to the score of DRAIZE. From 1 hour up to 72 hours after removal of the patches, no erythema and no edema reactions were observed. Based on the study results, the registration substance is not subject to labelling requirements with regard to skin irritating effects.
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.
