Registration Dossier
Registration Dossier
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EC number: 700-751-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 3/5/1991-2/9/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study to OECD protocol and subject to GLP audit.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rosin, fumarated
- EC Number:
- 266-040-8
- EC Name:
- Rosin, fumarated
- Cas Number:
- 65997-04-8
- IUPAC Name:
- Rosin, fumarated
- Details on test material:
- - Name of test material (as cited in study report): rosin, fumarated
- Substance type: chemically modified UVCB
- Physical state: solid
- Analytical purity: nominally 100%
- Stability under test conditions: assumed stable
- Storage condition of test material: ambient, protected from light
- Other: Certificate of analysis provided
Substance was stated to be tall oil rosin, hardened with fumaric acid (fortification grade 12%)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, UKr
- Age at study initiation:
- Weight at study initiation: 2.26-2.94 kg
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum):ad lib
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 deg C
- Humidity (%): 49-62%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 14-17 May 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test site moistened with approx 0.2 ml water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 3x2 cm
- % coverage:
- Type of wrap if used: gauze patch, Blendermstrips and and elasticated bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Standard EU Erythema/Eschar formation - scale 0-4
Oedema - scale 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: not applicable
- Irritant / corrosive response data:
- No irritant or corrosive response
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not classifiable.
- Executive summary:
Substance is not irritant when tested in an OECD 404 test subject to Good laboratory Practice audit.
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