Registration Dossier
Registration Dossier
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EC number: 278-934-5 | CAS number: 78521-39-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22. August - 13. October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to OECD guideline under GLP.
- Justification for type of information:
- Study was performed in 2000 according to OECD guideline 404, before REACH Regulation came into force. The available data is reliable without restriction and was used in order to meet the information requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , 17. July 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid
- EC Number:
- 278-934-5
- EC Name:
- 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid
- Cas Number:
- 78521-39-8
- Molecular formula:
- C13H19NO4S
- IUPAC Name:
- 6-(4-methylbenzenesulfonamido)hexanoic acid
- Reference substance name:
- 6-[](4-Methyl-phenyl)sulfonyl]amino]hexansäure
- IUPAC Name:
- 6-[](4-Methyl-phenyl)sulfonyl]amino]hexansäure
- Details on test material:
- - Name of test material (as cited in study report): ASC plus
- Substance type: white, christalline powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 0604
- Expiration date of the lot/batch: 12/2001
- Storage condition of test material: room temperature, dark
- Date of receipt: 23. August 2000
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: E. A. Prinzhorn, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.27 (female), 3.63 and 3.73 (male)
- Housing: individual in cages
- Diet: Harlan Teklad TLM Rabbit Maintenace Diet (ad libitum)
- Water: drinking water ad libitum
- Acclimation period: more than 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: back was clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 patches with each containing 0.5 g of undiluted test material were applied onto different areas of the back.
Control: one untreated area on the back - Duration of treatment / exposure:
- Animal No. 1:
3 min, 1 h, 4 h
Animals No 2 and 3 were additionally exposed each for 4 h because no treatment related effects were observed for animal No 1. - Observation period:
- skin was examined for signs of erythema and oedema according to the classification system of guideline OECD 404 at 1, 24, 48 and 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage:
- Type of wrap if used: Gaze-patches, Semiocclusive bandage with Ypsiplast (Holthaus Medical, Remscheid-Lüttringhausen), Elastoplast (Beiersdorf), Stülpa (Beiersdorf)
- skin was examined for signs of erythema and oedema
- clinical signs were examined as well.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- and edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not possible because no changes occured
- Remarks on result:
- other: There were no signs of redness or swelling at all time points.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks:
- not possible because no changes occurred
- Remarks on result:
- other:
- Remarks:
- There were no signs of redness or swelling at all time points.
- Irritant / corrosive response data:
- controls: score for erythema and oedema: 0 at all time points, no signs of redness or swelling.
No other toxicological symptoms were observed for treatments and controls.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- fully reliable study,
According to the results of this study: not irritating to skin. - Executive summary:
The test substance (CAS 78521-39-8) was applied to the back of 3 rabbits within a skin irritation test according to guideline OECD 404. 0.5 g of pure undiluted test material were applied in each of 3 patches in a semiocclusive way for 48 hours. Time points for observation were 1, 24, 48 and 72 hours after removal of the patch.
Scores for oedema and erythema: 0 at all time points.
No signs of redness or swelling and no other symptoms.
According to the results of this study the test material is considered as not irritating to 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.
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