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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
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): rosin, maleated
- 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: Trade name Dynakoll VS 50 M. 15.5% maleated. Certificate of analysis provided.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, UKr
- Age at study initiation:
- Weight at study initiation: 2.55-2.96 kg
- Housing: suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum):ad lib
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 deg C
- Humidity (%): 45-61%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 28-31 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: 1 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks on result:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
ca. 0.3
Max. score:
4
Reversibility:
fully reversible
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: 1 h
Score:
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:
Mean erythema score (24 to 72 hours) was 0.1 and mean oedema score (24 to 72 hours) was 0. In this study, rosin, maleated is not a dermal irritant.


Therefore, rosin, maleated is not classified for corrosion/ irritation in Annex I of Directive 67/548/EEC. Based on the absence of any signs of irritation during the study, this material is not classifiable for skin irritation according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a primary dermal irritation study, three New Zealand White rabbits were dermally exposed to 0.5 grams of rosin, maleated (CAS 8050 -28 -0) for 4 hours using a semi-occlusive dressing. Animals then were observed for 72 hours. Mean erythema and oedema scores were calucated for the 24 to 72 hour time period. Mean erythema score (24 to 72 hours) was 0.1 and mean oedema score (24 to 72 hours) was 0. In this study, rosin, maleated is not a dermal irritant.