Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts

Skin irritation / corrosion

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 OECD Guideline 404 and EU Method B.4 with no deviations that affected the results of the study.

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 for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of 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: GLP study conducted according to OECD Guideline 404 and EU Method B.4 with no deviations that affected the results of the study.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: No erythema was observed at the 24, 48 or 72-hour observation.

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No signs of edema were noted at 24, 48, or 72 hours after termination of exposure.

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:

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

Irritant / corrosive response data:

Except for slight erythema noted at the application site of a single rabbit one hour after termination of exposure, no signs of skin irritation (erythema and/or edema) were evident during the study.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Gum Rosin is not considered to be a skin irritant in rabbits when tested using the method described in OECD Guideline 404 and EU Method B.4. Gum Rosin is not classified in the Annex I of Directive 67/548/EEC for Skin Irritation/Corrosion. Based on the absence of any signs of erythema or edema at 24, 48, and 72 hours after termination of a 4-hour exposure to the test substance under semi-occlusive contact, Gum Rosin 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 male New Zealand white rabbits were dermally exposed on intact skin to 0.5 gram of Gum Rosin for 4 hours under semi-occlusive contact. Animals were then observed for a period of 72 hours post-treatment. Irritation was scored by the method described in OECD Guideline 404. Except for slight erythema noted at the application site of a single rabbit one hour after termination of exposure, no signs of skin irritation (erythema and/or edema) were evident during 24-, 48-, or 72-hour examinations. Based on mean values of 0 for both erythema and edema at the 24-, 48-, and 72-hour observations, Gum Rosin was not considered to be a skin irritant to rabbits, and presents a low irritation hazard upon skin contact under conditions of normal use.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rosin

EC Number:

232-475-7

EC Name:

Rosin

Cas Number:

8050-09-7

Molecular formula:

Unspecified.

IUPAC Name:

Rosin

Details on test material:

-Identity (according to study report): Rosin
-Source: Hexion Specialty Chemicals, BVBA
-Date received at Testing Laboratory: 15 October 2009
-Appearance: yellowish solid
-Storage: -20 °C
-Production date: June 2009
-Expiration date: June 2010
-Purity: 100%
-Code No.: PH-09/0286
-The test sample was used as supplied, after being reduced to a fine powder.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-Source: Elevage de Gerome (Quartier Labaste F40206 Linxe)
-Animals: 3 males
-Acclimation period: at least 5 days
-Weight at study initiation: 2.25-2.85 kg
-Age at study initiation: 11 or 12 weeks
-Housing: 1/cage in air conditioned rooms
-Diet: SDS-C15, available ad libitum
-Water: drinking water (tap-water from public distribution system) available ad libitum

ENVIRONMENTAL CONDITIONS:
-Room temperature (ºC): 17-23
-Relative humidity (%): 30-70
-Air exchanges: 15 changes/hour
-Light: 12 hour light/dark cycle

IN-LIFE DATES:
-Date of experiment initiation: 03 November 2009
-Date of experiment termination: 13 November 2009

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: An untreated area on the opposite side of the treated flank served as a control.

Amount / concentration applied:

0.5 gram of the neat test substance moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Approximately 24 hours prior to study initiation, the backs and flanks of 3 male rabbits were shaved with an electric clipper equipped with a fine comb to expose an area of skin about 6 cm x 6 cm. Initially one rabbit was treated by applying 0.5 gram of the test substance, moistened with distilled water, to an undamaged area of one flank. The test site was covered with a patch secured in place with a strip of surgical tape under a semi-occlusive dressing. Since no tissue damage was observed after a 3-minute and 1-hour exposure, the exposure period was extended for a 4-hour exposure to the test substance. Based on the lack of a skin response at the 3-minute and 1-hour observations, two additional rabbits were exposed to the test material in the same manner for a period of 4 hours. After termination of the 4-hour exposures, the patches were removed and the application sites were rinsed with distilled water. Observations for skin reactions were noted and recorded at 1, 24, 48, and 72 hours after termination of exposure. Evaluation of skin reactions were performed using the table Grading of Skin Reactions as described in OECD Guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: No erythema was observed at the 24, 48 or 72-hour observation.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No signs of edema were noted at 24, 48, or 72 hours after termination of exposure.

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Irritant / corrosive response data:

Except for slight erythema noted at the application site of a single rabbit one hour after termination of exposure, no signs of skin irritation (erythema and/or edema) were evident during the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Gum Rosin is not considered to be a skin irritant in rabbits when tested using the method described in OECD Guideline 404 and EU Method B.4. Gum Rosin is not classified in the Annex I of Directive 67/548/EEC for Skin Irritation/Corrosion. Based on the absence of any signs of erythema or edema at 24, 48, and 72 hours after termination of a 4-hour exposure to the test substance under semi-occlusive contact, Gum Rosin 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 male New Zealand white rabbits were dermally exposed on intact skin to 0.5 gram of Gum Rosin for 4 hours under semi-occlusive contact. Animals were then observed for a period of 72 hours post-treatment. Irritation was scored by the method described in OECD Guideline 404. Except for slight erythema noted at the application site of a single rabbit one hour after termination of exposure, no signs of skin irritation (erythema and/or edema) were evident during 24-, 48-, or 72-hour examinations. Based on mean values of 0 for both erythema and edema at the 24-, 48-, and 72-hour observations, Gum Rosin was not considered to be a skin irritant to rabbits, and presents a low irritation hazard upon skin contact under conditions of normal use.