Registration Dossier
Registration Dossier
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EC number: 248-778-2 | CAS number: 28016-00-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- limited report, non-GLP, test with formulation. limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA, CFR Title 21, para. 191.11
- GLP compliance:
- no
Test material
- Reference substance name:
- Zinc bis(dinonylnaphthalenesulphonate)
- EC Number:
- 248-778-2
- EC Name:
- Zinc bis(dinonylnaphthalenesulphonate)
- Cas Number:
- 28016-00-4
- Molecular formula:
- Zn[C28H43O3S]2
- IUPAC Name:
- Zinc bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate))
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Bodyweight: 2.3 to 3.0 kg
No further details
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% in diluent oil - Duration of treatment / exposure:
- 24 hours
- Observation period:
- scored 24 and 72 hours after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Abrasions made over 2-3 cm2
- Type of wrap if used: plastic trunk band to prevent evaporation
REMOVAL OF TEST SUBSTANCE
- Washing (if done):none
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- ca. 3.66
- Reversibility:
- not reversible
- Remarks on result:
- other: score for non-abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- ca. 0.16
- Reversibility:
- not reversible
- Remarks on result:
- other: score for non-abraded skin
- Irritant / corrosive response data:
- The results are presented for the abraded and non-abraded skin.
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material is irritating to the rabbit's skin.
- Executive summary:
Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant.
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