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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-471-0 | CAS number: 117309-52-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 11 February 1992 and 14 February 1992.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(naphthalene-2-sulfonamido)benzoic acid
- EC Number:
- 601-471-0
- Cas Number:
- 117309-52-1
- Molecular formula:
- C17H13NO4S
- IUPAC Name:
- 2-(naphthalene-2-sulfonamido)benzoic acid
- Test material form:
- solid
- Details on test material:
- Test material: NSABZ (2-(Naphthalene-2'-sulphonylamino)-benzoic acid)
Date of receipt: 20 December 1991.
Description: Very light brown powder.
Storage: In original container at room temperature.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For the purpose of this study the test material was moistened with distilled water immediately before application.
- Final dilution of a dissolved solid, stock liquid or gel: 0.5g of the test material was moistened with 0.5 ml of distilled water
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.26 - 2.34 kg
- Housing: individual housing in suspended metal cages
- Diet (e.g. ad libitum): Free access to food (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
- Water (e.g. ad libitum): free access to drinking water and food was allowed throughout the study.
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22°C
- Humidity (%): 41 - 43%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test material, moistened with 0.5 ml of distilled water
- Concentration (if solution): not specified - Duration of treatment / exposure:
- 4h
- Observation period:
- 24, 48 and 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch on the shorn skin
- Type of wrap if used: strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h after application
OBSERVATION TIME POINTS
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later
SCORING SYSTEM:
- Scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- Method of calculation: The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 2-(Naphthalen-2-sulfonylamino)benzoic acid did not produce positive criteria in any rabbit according to the EC labelling regulations and was classified as NON-IRRITANT to rabbit skin.
- Executive summary:
Study was performed to assess the irritancy potential of 2-(Naphthalen-2-sulfonylamino)benzoic acid following a single, 4-hour, semi-occluded application on New Zealand White rabbit following OECD guideline number 204 of 1981. 2-(Naphthalen-2 -sulfonylamino)benzoic acid did not produce positive criteria in any rabbit according to the EC labelling regulations and was classified as NON-IRRITANT to rabbit skin.
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.
