Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing used
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 68477-54-3
- Cas Number:
- 68477-54-3
- IUPAC Name:
- 68477-54-3
- Reference substance name:
- C9 resinfeed
- IUPAC Name:
- C9 resinfeed
- Details on test material:
- - Name of test material (as cited in study report): "C9 Resinfeed"
- Physical state: clear yellow/brown liquid
- Storage conditions: Room temperature
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: ENKI-Konijnenfarm, Someran, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2400-2850 g
- Housing: Individually in suspended, galvanised cages
- Diet: Standard laboratory rabbit diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 3°C
- Humidity: at least 40%
- Air changes: 10 per hr
- Photoperiod (hrs dark / hrs light): natural light cycle
IN-LIFE DATES: From: 22 May 1989 To: 13 June 1989
Test system
- Type of coverage:
- occlusive
- 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 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm area on back and/or flank
- Type of wrap if used: 2.5 x 2.5 cm patch (Melolin) fixed to application site with adhesive tape then entire trunk wrapped with self-adhesive gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No details reported
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: severe erythema seen
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: severe oedema seen
- Other effects:
- After 72 hours, slight incrustation was present in two rabbits. After 7 days, moderate scaliness was observed in one rabbit and moderate incrustation in the other two. After 12 days, skin effects had cleared in two rabbits but after 13 days moderate scaliness still persisted in the third rabbit but had cleared after 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- C9 Resinfeed is irritating but not corrosive to the skin.
- Executive summary:
The skin irritant potential of undiluted C9 Resinfeed (CAS 68477-54-3) was assessed in 3 New Zealand white rabbits using an exposure period of 4 hours. Severe erythema, moderate incrustation, moderate scaliness and severe oedema were seen in all 3 rabbits.
All effects had completely resolved 21 days after treatment. It can be concluded that C9 Resinfeed (CAS 68477-54-3) is irritating to rabbit skin and justifies classification Category 2, H315 under GHS/CLP.
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