Registration Dossier
Registration Dossier
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EC number: 290-636-7 | CAS number: 90194-27-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- EC Number:
- 274-263-7
- EC Name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- Cas Number:
- 70024-69-0
- IUPAC Name:
- sodium 4-icosylbenzenesulfonate
- Details on test material:
- Storage condition of test material: room temperature and humidity
- Other: Brown liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, PA
- Weight at study initiation: 2.9-3.1 kg
- Housing: 1 animal/cage in suspended wire cages
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle washing with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Mean score calculated by average of results at 24h, 48h, and 72 h for each animal.
- Other effects:
- Animals did not display any abnormal signs throughout the test period. Bodyweights did not significantly alter.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Oedema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
1/0/1 |
0/0/1 |
24 h |
1/0/1 |
0/0/1 |
48 h |
1/0/2 |
0/0/1 |
72 h |
0/0/2 |
0/0/1 |
Average 24h, 48h, 72h |
0.7/1/0.7 |
0.3/0.3/0.3 |
Reversibility*) |
c/c/c |
c/c/c |
Average time (unit) for reversion |
72/0/14d |
0/0/14d |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is determined to be non-irritating.
- Executive summary:
In a primary dermal irritation study , 3 young adult New Zealand white rabbits were dermally exposed to 0.5 ml of Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
In this study, Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts is not a dermal irritant.
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