Registration Dossier
Registration Dossier
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EC number: 219-669-7 | CAS number: 2494-89-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.02.1978 - 16.03.1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP
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: FDA guideline (federal register Vol. 38, No. 187, p. 27019, 1973)
- Principles of method if other than guideline:
- Patch-Test, okklusiv
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[(p-aminophenyl)sulphonyl]ethyl hydrogensulphate
- EC Number:
- 219-669-7
- EC Name:
- 2-[(p-aminophenyl)sulphonyl]ethyl hydrogensulphate
- Cas Number:
- 2494-89-5
- Molecular formula:
- C8H11NO6S2
- IUPAC Name:
- [2-(4-aminobenzenesulfonyl)ethoxy]sulfonic acid
- Details on test material:
- IUCLID5 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG (HIMK (SPFWiga))
- Age at study initiation: months
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: single
- Diet (ad libitum): Mischfutter ERKA 8300
- Water (ad libitum): tap water from automated supply
- Acclimation period: NA
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: comparison to untreated skin
- Amount / concentration applied:
- 500 mg pasted with 0.25 ml of 0.9 % NaCl-solution
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
EVALUATION TIME:
immediatetly, 24, 48 hours after removal of bandage
SCORING SYSTEM: according to test guideline
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Classification: not irritating
- Executive summary:
Testing of para - Base - Ester for skin irritation in rabbits according to FDA guideline (federal register Vol. 38, No. 187, p. 27019, 1973) . According to results the test item has not to be classified as skin irritant.
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