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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to guideline method
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of 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: GLP study conducted according to guideline method
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1hr
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24hrs
Remarks on result:
other: Score was 0.0 at 24, 48, and 72hrs
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1hr
Score:
0
Max. score:
4
Remarks on result:
other: Score was 0.0 at 24, 48, and 72hrs
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritant / corrosive response data:
One hour after removal of the dressing, a very slight erythema was observed in 3 animals. No further cutaneous reactions persisted after 24, 48 and 72 hours.
Other effects:
no data

no data

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Resin acids and Rosin acids, fumarated, esters with pentaerythritol 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.

Resin acids and Rosin acids, fumarated, esters with pentaerythritol 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:

This data is being read across from the source study that tested Resin acids and Rosin acids, fumarated, esters with pentaerythritol based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In a primary dermal irritation study, six young adult New Zealand white rabbits were exposed to 500 mg of Bevilite 62-115 (resin acids and rosin acids, fumarated, esters with pentaerythritol) 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, Bevilite 62-115 (resin acids and rosin acids, fumarated, esters with pentaerythritol) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard. 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
n/a
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Bevilite 62-115
- Substance type: Reaction product derived from UVCB
- Physical state: yellow grains
- Lot/batch No.: 910592

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Begrolles en Mauges, France)
- Age at study initiation:
- Weight at study initiation: 2.6+/10.1kg
- Housing: Individually housed in polystyrene cages.
- Diet (e.g. ad libitum): ad libitum, with certified pellet diet 'Rabbits sustenance ref: 112 C' (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, filtered tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3C
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: June 13, 1990 To: June 16, 1990

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: left flank as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg
Duration of treatment / exposure:
4hrs
Observation period:
24, 48 and 72 hrs after removal of patch
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: The test substance was ground down to a fine dust and applied to a 6 cm2 hydrophilic gauze patch saturated with 0.5ml of water.
- % coverage:
- Type of wrap if used:The gauze patch was held by an adhesive hypoallergic aerated semi-occlusive dressing attached to a gauze bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance not rinsed-off
- Time after start of exposure: Dressings were removed after 4hrs exposure

SCORING SYSTEM:
See Table 1 under 'Any other information on materials and methods incl. tables'

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1hr
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24hrs
Remarks on result:
other: Score was 0.0 at 24, 48, and 72hrs
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1hr
Score:
0
Max. score:
4
Remarks on result:
other: Score was 0.0 at 24, 48, and 72hrs
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: Individual animal scores not provided; only mean scores available
Irritant / corrosive response data:
One hour after removal of the dressing, a very slight erythema was observed in 3 animals. No further cutaneous reactions persisted after 24, 48 and 72 hours.
Other effects:
no data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Resin acids and Rosin acids, fumarated, esters with pentaerythritol 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.

Resin acids and Rosin acids, fumarated, esters with pentaerythritol 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 500 mg of Bevilite 62-115 (resin acids and rosin acids, fumarated, esters with pentaerythritol) 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, Bevilite 62-115 (resin acids and rosin acids, fumarated, esters with pentaerythritol) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.