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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 811-484-5 | CAS number: 680972-33-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: Read across from category (Hydrotropes)
- Adequacy of study:
- key study
- Study period:
- 1993-06-22 to 1993-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 404 (Acute Dermal Irritation / Corrosion) and in complaince with Good Laboratory Practice Regulations as described by the OECD annex 2 C(81)30.
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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Room temperature is 21°C to 25°C, Humidity is 54%to 89%, Dose is (0.20 g) 200mg
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium Cumenesulphonic acid
- IUPAC Name:
- Sodium Cumenesulphonic acid
- Details on test material:
- - Name of test material (as cited in study report): Low Completion Index SE2SI (SEC-Base) (Sodium cumenesulphonate)- Molecular formula (if other than submission substance): C9H12O3S - Molecular weight (if other than submission substance): na- Substance type: Pure active substance- Physical state: Solid - Analytical purity: See below- Impurities (identity and concentrations): See below- Composition of test material, percentage of components: See below- Isomers composition: See below- Purity test date: See below- Lot/batch No.: See below- Expiration date of the lot/batch: See below- Stability under test conditions: See below- Storage condition of test material: Room temperature in a dessicator- Other:See below
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Rabbitry,Loudonville,Ohio
- Age at study initiation: na
- Weight at study initiation: 2.1 to 2.5 grams
- Housing: Individually housed in stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rabbit chow # 5322
- Water (e.g. ad libitum):Water purified by reverse osmosis -ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 25°C
- Humidity (%): 54% to 89%
- Air changes (per hr): na
- Photoperiod (hrs dark / hrs light): 12 hour dark and 12 hour light
IN-LIFE DATES: From: 1993-06-22 To: 1993-06-25
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200mg of test article
- Concentration (if solution): na
VEHICLE
- Amount(s) applied (volume or weight with unit):na
- Concentration (if solution):na
- Lot/batch no. (if required): na
- Purity:na - Duration of treatment / exposure:
- Three adult New Zealand white rabbits were treated with 200 mg of the test substance on to the intact skin sites with 25 mm Hilltop chamber with cotton pad.After 4 hours exposure period, the expendover tape were removeed and the treated sites were observed for erythema and edema at 4hr, 24 hour 48 hour and 72 hours.
- Observation period:
- 41/2 hour,24 hour, 48 hour and 72 hours.
- Number of animals:
- Three New Zealand white rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk of each animal
- % coverage: na
- Type of wrap if used: Wrappings of Expandover and Athletic tape was used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): na
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Eschar formation:
0=no erythema, 1= very slight erythema, 2= slight erythema, 3=moderate to severe erythema, 4=severe erytheama, 4/4 highest possible erythema score
Edema formation:
0=no edema, 1=very slight edema, 2=slight edema, 3=moderate to severe edema, 4=severe edema,4/4 =highest possible edema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hr
- Score:
- 1.33
- Max. score:
- 1.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 2 rabbits with grade 1 & 1 with grade 1
- Time point:
- other: 4 hr
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin iste
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 3 rabbits with grade 1
- Time point:
- other: 4 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.66
- Max. score:
- 1.66
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 rabbit with grade 1 & 2 with grade 2
- Time point:
- 24 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 3 rabbits with grade 0
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.66
- Max. score:
- 0.66
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 rabbit with grade 0 & 2 with grade 1
- Time point:
- 48 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 3 rabbits with grade 0
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin site
- Irritant / corrosive response data:
- PII 1.33 at 4 hours at erythema and 1.0 at edema intact skin site
PII 1.66 at 24 hours at erythema and 0.0 at edema intact skin site
PII 0.66 at 48 hours at erythema and 0.0 at edema intact skin site
PII 0.0 at 72 hours at erythema and 0.0 at edema intact skin site - Other effects:
- None
Any other information on results incl. tables
| Animal number | Degreeof erythema after (Observation ime) | Degreeof edema after (Observation ime) | Mean >=1.5 <2.3 ? | ||||||
| 24 hr | 48 hr | 72 hr | 24 hr | 48 hr | 72 hr | Erythema | Edema | ||
7803 |
1 | 2 | 2 | 0 | 0 | 0 | YES | NO | |
| Mean= 1.66 | Mean= 0.00 | ||||||||
| 7788 | 0 | 1 | 1 | 0 | 0 | 0 | NO | NO | |
| Mean=0.66 | Mean= 0.00 | ||||||||
| 7789 | 0 | 0 | 0 | 0 | 0 | 0 | NO | NO | |
| Mean= 0.00 | Mean= 0.00 | ||||||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is a mild skin irritant but no classification is requested under CLP Regulation.
- Executive summary:
Three New Zealand white rabbits were treated with 200 mg of test substance occlusively, produced slight erythema of all 3 three animals at 4.5 hours reading. Similar observations were made at 24hr, 48 hr and 72 hours. The skin responses completely resolved by 72 hours reading. Based on the observations, the test substance is a mildly irritating to the dermal tissue of the rabbit.
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.
