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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 based on grouping of substances (category approach)
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
Type:
Constituent
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 providedSubstance 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 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 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18-19 deg C- Humidity (%): 49-62%- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12IN-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 gTEST 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 bandageREMOVAL OF TEST SUBSTANCE- Washing (if done): warm water- Time after start of exposure: 4 hSCORING SYSTEM:Standard EU Erythema/Eschar formation - scale 0-4Oedema - 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 informationCriteria used for interpretation of results: EU
Conclusions:
Rosin, fumarated is not a primary skin irritant when tested using a method similar to that described in OECD Guideline 404. Mean erythema and edema scores for 24 to 72 hours were observed 0 in intact rabbit skin exposed to the test material under semi-occluded contact for 4 hours. Rosin, fumarated 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, six young adult New Zealand white rabbits were exposed to 0.5 g of rosin, fumarated applied for 4 hours under semi-occluded contact to intact skin. Methods used in this study were compliant with current guidelines (OECD 404). Animals were then observed for a period of 72 hours post-treatment. Irritation was scored. Mean erythema and edema scores for 24 to 72 hours were observed 0 in intact rabbit skin exposed to the test material under semi-occluded contact for 4 hours. Based on these findings, rosin, fumarated was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.