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Toxicological information

Skin irritation / corrosion

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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:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
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%)

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.