Registration Dossier
Registration Dossier
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EC number: 203-768-7 | CAS number: 110-44-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- The study was conducted within the frame of the existing substance program EU(XXX). In vitro methods were not available at that time. Therefore, an in vivo study was conducted.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 March 1987 - 27 March 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant OECD guidelines study, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hexa-2,4-dienoic acid
- EC Number:
- 203-768-7
- EC Name:
- Hexa-2,4-dienoic acid
- Cas Number:
- 110-44-1
- Molecular formula:
- C6H8O2
- IUPAC Name:
- hexa-2,4-dienoic acid
- Details on test material:
- Name of test material as cited in test report: Sorbinsäure; trans-trans-2,4-Hexadiensäure; 2,4-Hexadienoic acid (trans, trans)
Physical state: colouless crystals
Purity: 99% (according to the specification)
Impurities (identity and concentrations): According to the specification: <0.1% Aldehydes (calculated as Formaldehyde); < 1 ppm arsenic, mercury; < 5 ppm lead, zinc, copper
Molecular weight: 112,12 g/mol
Product Number: IKSS 205, IKSS 215, IKSS 225, CUSO 445, CUSO 645
Storage condition of test material: at 4°C in a fridge in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino New Zeland
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: HOECHST AG, Kastengrund, konventionalle Zucht
Age at study initiation: 3-5 months
Weight at study initiation: 2.9 - 3.3 kg
Housing: fully air-conditioned rooms in single cages
Diet: Altromin rabbit diet ad libitum
Water: deionised and dechlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50+/- 20%
- Photoperiod (hrs dark / hrs light): 12hrs/12 hrs
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethylenglycol
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per plaster
- Concentration (if solution): pure substance (solid)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml
- Concentration (if solution): pure substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min, and 24, 48, and 72 hours after patch removal
- Number of animals:
- three
- Details on study design:
- TEST SITE
- Area of exposure: about 2.5x2.5 cm of the dorsal part of the trunk
- Type of wrap if used: cellulose pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes. Residues of the test substances were washed off with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- During the study, no signs of irritation were observed.
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- non irritating
- Executive summary:
A 4 hour semi-occlusive application of sorbic acid to the inatct skin of three rabbits did not produce erythema nor edema. Based on test results, the test material was classified as not skin irritating to rabbit skin according to Draize classification scheme.
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