Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
