Registration Dossier

The dermal irritation potential of Resin acids and Rosin acids, ammonium salts was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the skin of New Zealand White rabbits.

Based on the estimated results, Resin acids and Rosin acids, ammonium salts can be considered not irritating to skin and can be classified under the category “Not Classified” as per CLP regulation.

The ocular irritation potential of Resin acids and Rosin acids, ammonium salts was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the eyes of New Zealand White rabbits.

Based on the estimated results, Resin acids and Rosin acids, ammonium salts can be considered not irritating to eyes and can be classified under the category “Not Classified” as per CLP regulation

Reference

Endpoint:

skin irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction was done using OECD QSAR toolbox v3.3

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Resin acids and Rosin acids, ammonium salts
- Regulatory name: Resin acids and Rosin acids, ammonium salts
- Molecular formula: Not specified
- Molecular weight: Not specified
- Substance type: Organic
- Physical State: Solid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

5

Details on study design:

no data available

Other effects / acceptance of results:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation

Estimation method: Takes mode value from the 7 nearest neighbours
Domain logical expression:Result: In Domain

(((((((((("a" or "b" or "c" or "d" ) and ("e" and ( not "f") ) ) and "g" ) and "h" ) and "i" ) and "j" ) and "k" ) and "l" ) and ("m" and ( not "n") ) ) and ("o" and "p" ) )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon OR Bridged-ring carbocycles OR Carbocyclic spiro rings OR Carboxylic acid OR Cycloalkane OR Cycloalkene OR Fused saturated carbocycles OR Isopropyl OR O-Alkyl hydroxylamine by Organic Functional groups ONLY

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon OR Bridged-ring carbocycles OR Carbocyclic spiro rings OR Carboxylic acid OR Cycloalkane OR Fused saturated carbocycles OR Isopropyl OR O-Alkyl hydroxylamine OR Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Acid, aliphatic attach [-COOH] OR Alcohol, olefinic attach [-OH] OR Aliphatic Carbon [CH] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Amino acid, non-alpha carbon type OR Amino acid, olefine non-alpha type OR Carbonyl, aliphatic attach [-C(=O)-] OR Fused Aliphatic ring unit OR Miscellaneous sulfide (=S) or oxide (=O) OR Nitrogen, hydrogen attach {v+5} OR Olefinic carbon [=CH- or =C<] OR Oxygen or Sulfur, nitrogen attach [-O- or -S-] OR Oxygen, nitrogen attach [-O-] OR Tertiary Carbon by Organic functional groups (US EPA) ONLY

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Carbonic acid derivative OR Carboxylic acid OR Carboxylic acid derivative by Organic functional groups, Norbert Haider (checkmol) ONLY

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as No alert found by DNA binding by OECD

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> P450 Mediated Activation to Isocyanates or Isothiocyanates OR Acylation >> P450 Mediated Activation to Isocyanates or Isothiocyanates >> Formamides OR Michael addition OR Michael addition >> Polarised Alkenes-Michael addition OR Michael addition >> Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated amides OR Michael addition >> Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated esters OR SN1 OR SN1 >> Iminium Ion Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines OR SN2 OR SN2 >> Direct Acting Epoxides and related OR SN2 >> Direct Acting Epoxides and related >> Epoxides by DNA binding by OECD

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis ONLY

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon AND Bridged-ring carbocycles AND Carbocyclic spiro rings AND Carboxylic acid AND Cycloalkane AND Fused saturated carbocycles AND Isopropyl AND O-Alkyl hydroxylamine AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Acid, aliphatic attach [-COOH] AND Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Amino acid, non-alpha carbon type AND Amino acid, olefine non-alpha type AND Carbonyl, aliphatic attach [-C(=O)-] AND Fused Aliphatic ring unit AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, hydrogen attach {v+5} AND Olefinic carbon [=CH- or =C<] AND Oxygen or Sulfur, nitrogen attach [-O- or -S-] AND Oxygen, nitrogen attach [-O-] AND Tertiary Carbon by Organic functional groups (US EPA) ONLY

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Carbonic acid derivative AND Carboxylic acid AND Carboxylic acid derivative by Organic functional groups, Norbert Haider (checkmol) ONLY

Domain logical expression index: "k"

Similarity boundary:Target: HN(H)(H)OC(=O)C1C(C(O)=O)C2CC3C1(CCC1C3(C)CCCC1(C)C(O)=O)C=C2C(C)C
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "l"

Similarity boundary:Target: HN(H)(H)OC(=O)C1C(C(O)=O)C2CC3C1(CCC1C3(C)CCCC1(C)C(O)=O)C=C2C(C)C
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "m"

Referential boundary: The target chemical should be classified as Inclusion rules not met by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "n"

Referential boundary: The target chemical should be classified as Aliphatic acids and (Met)acrylic acids by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "o"

Parametric boundary:The target chemical should have a value of log Kow which is >= -0.263

Domain logical expression index: "p"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3.17

Interpretation of results:

other: not irritating

Conclusions:

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the skin of New Zealand White rabbits.

Executive summary:

The dermal irritation potential of Resin acids and Rosin acids, ammonium salts was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the skin of New Zealand White rabbits.

Based on the estimated results, Resin acids and Rosin acids, ammonium salts can be considered not irritating to skin and can be classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction was done using OECD QSAR toolbox v3.3

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Resin acids and Rosin acids, ammonium salts
- Regulatory name: Resin acids and Rosin acids, ammonium salts
- Molecular formula: Not specified
- Molecular weight: Not specified
- Substance type: Organic
- Physical State: Solid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

72 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3

Details on study design:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no signs of irritation observed

Estimation method: Takes mode value from the 8 nearest neighbours
Domain logical expression:Result: In Domain

((((((((((((((((((("a" or "b" or "c" or "d" ) and ("e" and ( not "f") ) ) and ("g" and ( not "h") ) ) and ("i" and ( not "j") ) ) and "k" ) and ("l" and ( not "m") ) ) and "n" ) and "o" ) and ("p" and ( not "q") ) ) and ("r" and ( not "s") ) ) and ("t" and ( not "u") ) ) and ("v" and ( not "w") ) ) and ("x" and ( not "y") ) ) and ("z" and ( not "aa") ) ) and "ab" ) and "ac" ) and "ad" ) and "ae" ) and ("af" and "ag" ) )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon OR Bridged-ring carbocycles OR Carbocyclic spiro rings OR Carboxylic acid OR Cycloalkane OR Cycloalkene OR Fused saturated carbocycles OR Isopropyl OR O-Alkyl hydroxylamine by Organic Functional groups ONLY

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon OR Bridged-ring carbocycles OR Carbocyclic spiro rings OR Carboxylic acid OR Cycloalkane OR Fused saturated carbocycles OR Isopropyl OR O-Alkyl hydroxylamine OR Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Acid, aliphatic attach [-COOH] OR Alcohol, olefinic attach [-OH] OR Aliphatic Carbon [CH] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Amino acid, non-alpha carbon type OR Amino acid, olefine non-alpha type OR Carbonyl, aliphatic attach [-C(=O)-] OR Fused Aliphatic ring unit OR Miscellaneous sulfide (=S) or oxide (=O) OR Nitrogen, hydrogen attach {v+5} OR Olefinic carbon [=CH- or =C<] OR Oxygen or Sulfur, nitrogen attach [-O- or -S-] OR Oxygen, nitrogen attach [-O-] OR Tertiary Carbon by Organic functional groups (US EPA) ONLY

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Carbonic acid derivative OR Carboxylic acid OR Carboxylic acid derivative by Organic functional groups, Norbert Haider (checkmol) ONLY

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as No alert found by DNA binding by OASIS v.1.3

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as AN2 OR AN2 >> Shiff base formation after aldehyde release OR AN2 >> Shiff base formation after aldehyde release >> Specific Acetate Esters OR Radical OR Radical >> Generation of reactive oxygen species OR Radical >> Generation of reactive oxygen species >> Thiols OR Radical >> Radical mechanism by ROS formation (indirect) or direct radical attack on DNA OR Radical >> Radical mechanism by ROS formation (indirect) or direct radical attack on DNA >> Organic Peroxy Compounds OR SN1 OR SN1 >> Nucleophilic attack after carbenium ion formation OR SN1 >> Nucleophilic attack after carbenium ion formation >> Specific Acetate Esters OR SN2 OR SN2 >> Acylation OR SN2 >> Acylation >> Specific Acetate Esters OR SN2 >> Alkylation, direct acting epoxides and related OR SN2 >> Alkylation, direct acting epoxides and related >> Epoxides and Aziridines OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Specific Acetate Esters by DNA binding by OASIS v.1.3

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.3

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> (Thio)Acyl and (thio)carbamoyl halides and cyanides OR Acylation >> Direct acylation involving a leaving group >> Anhydrides (sulphur analogues of anhydrides) OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR Michael Addition OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-Carbonyl compounds with polarized double bonds OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group >> Conjugated systems with electron withdrawing groups OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group >> Cyanoalkenes OR Nucleophilic addition OR Nucleophilic addition >> Addition to carbon-hetero double bonds OR Nucleophilic addition >> Addition to carbon-hetero double bonds >> Ketones OR Radical reactions OR Radical reactions >> Free radical formation OR Radical reactions >> Free radical formation >> Hydroperoxides OR SN2 OR SN2 >> SN2 Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction at a sp3 carbon atom >> Activated alkyl esters and thioesters by Protein binding by OASIS v1.3

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct Acylation Involving a Leaving group OR Acylation >> Direct Acylation Involving a Leaving group >> Acetates OR Michael addition OR Michael addition >> Polarised Alkenes OR Michael addition >> Polarised Alkenes >> Polarised alkene - esters by Protein binding by OECD

Domain logical expression index: "k"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis ONLY

Domain logical expression index: "l"

Referential boundary: The target chemical should be classified as Non-Metals by Groups of elements

Domain logical expression index: "m"

Referential boundary: The target chemical should be classified as Alkali Earth OR Alkaline Earth OR Halogens OR Metalloids OR Metals OR Rare Earth OR Transition Metals by Groups of elements

Domain logical expression index: "n"

Similarity boundary:Target: HN(H)(H)OC(=O)C1C(C(O)=O)C2CC3C1(CCC1C3(C)CCCC1(C)C(O)=O)C=C2C(C)C
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "o"

Similarity boundary:Target: HN(H)(H)OC(=O)C1C(C(O)=O)C2CC3C1(CCC1C3(C)CCCC1(C)C(O)=O)C=C2C(C)C
Threshold=30%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "p"

Referential boundary: The target chemical should be classified as Not categorized by Repeated dose (HESS)

Domain logical expression index: "q"

Referential boundary: The target chemical should be classified as Aliphatic/Alicyclic hydrocarbons (Alpha 2u-globulin nephropathy) Rank C OR Carboxylic acids (Hepatotoxicity) No rank OR Perhexiline (Hepatotoxicity) Alert OR Valproic acid (Hepatotoxicity) Alert by Repeated dose (HESS)

Domain logical expression index: "r"

Referential boundary: The target chemical should be classified as (!Undefined)Group All Lipid Solubility < 0.01 g/kg AND (!Undefined)Group C Surface Tension > 62 mN/m AND Group All Melting Point > 200 C AND Group C Melting Point > 55 C AND Group C Molecular Weight > 350 g/mol AND Group C Vapour Pressure < 0.0001 Pa by Skin irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "s"

Referential boundary: The target chemical should be classified as (!Undefined)Group CN Lipid Solubility < 0.4 g/kg OR Exclusion rules not met OR Group All log Kow < -3.1 by Skin irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "t"

Referential boundary: The target chemical should be classified as No alert found by rtER Expert System ver.1 - USEPA

Domain logical expression index: "u"

Referential boundary: The target chemical should be classified as Multi Cyclic Hydrocarbons by rtER Expert System ver.1 - USEPA

Domain logical expression index: "v"

Referential boundary: The target chemical should be classified as (!Undefined)Group All Lipid Solubility < 0.01 g/kg AND Group All Melting Point > 200 C AND Group C Melting Point > 55 C AND Group C Molecular Weight > 380 g/mol by Eye irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "w"

Referential boundary: The target chemical should be classified as Group C Aqueous Solubility < 0.0005 g/L by Eye irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "x"

Referential boundary: The target chemical should be classified as No alert found by Carcinogenicity (genotox and nongenotox) alerts by ISS

Domain logical expression index: "y"

Referential boundary: The target chemical should be classified as alpha,beta-unsaturated aliphatic alkoxy group (Genotox) OR Phtalate (or buthyl) diesters and monoesters (Nongenotox) OR Structural alert for genotoxic carcinogenicity OR Structural alert for nongenotoxic carcinogenicity by Carcinogenicity (genotox and nongenotox) alerts by ISS

Domain logical expression index: "z"

Referential boundary: The target chemical should be classified as Aliphatic acid [-C(=O)-OH] AND -C=CH [alkenyl hydrogen] AND Carbon with 4 single bonds & no hydrogens AND -CH - [cyclic] AND -CH- [linear] AND -CH2- [cyclic] AND Methyl [-CH3] AND Quaternary amine by Biodegradation fragments (BioWIN MITI)

Domain logical expression index: "aa"

Referential boundary: The target chemical should be classified as Aliphatic ether [C-O-C] by Biodegradation fragments (BioWIN MITI)

Domain logical expression index: "ab"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon AND Bridged-ring carbocycles AND Carbocyclic spiro rings AND Carboxylic acid AND Cycloalkane AND Fused saturated carbocycles AND Isopropyl AND O-Alkyl hydroxylamine AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "ac"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon AND Bridged-ring carbocycles AND Carbocyclic spiro rings AND Carboxylic acid AND Cycloalkane AND Fused saturated carbocycles AND Isopropyl AND O-Alkyl hydroxylamine AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "ad"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon AND Bridged-ring carbocycles AND Carbocyclic spiro rings AND Carboxylic acid AND Cycloalkane AND Fused saturated carbocycles AND Isopropyl AND O-Alkyl hydroxylamine AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "ae"

Referential boundary: The target chemical should be classified as Alkane, branched with tertiary carbon AND Bridged-ring carbocycles AND Carbocyclic spiro rings AND Carboxylic acid AND Cycloalkane AND Fused saturated carbocycles AND Isopropyl AND O-Alkyl hydroxylamine AND Overlapping groups by Organic Functional groups (nested) ONLY

Domain logical expression index: "af"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.69

Domain logical expression index: "ag"

Parametric boundary:The target chemical should have a value of log Kow which is <= 3.18

Interpretation of results:

other: not irritating

Conclusions:

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the eyes of New Zealand White rabbits.

Executive summary:

The ocular irritation potential of Resin acids and Rosin acids, ammonium salts was estimated using OECD QSAR toolbox v3.3 with logPow as the primary descriptor.

Resin acids and Rosin acids, ammonium salts was estimated to be not irritating to the eyes of New Zealand White rabbits.

Based on the estimated results, Resin acids and Rosin acids, ammonium salts can be considered not irritating to eyes and can be classified under the category “Not Classified” as per CLP regulation

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin Irritation:

In different studies,Resin acids and Rosin acids, ammonium saltshas been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its functionally similar read across substances, Glycerol esters of rosin [CAS: 8050-31-5] and Dehydroabietic acid[CAS: 1740-19-8].The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin irritation potential was estimated forResin acids and Rosin acids, ammonium salts.Resin acids and Rosin acids, ammonium saltswas estimated to be not irritating to skin of New Zealand White rabbits.

This result is supported by the experimental study summarized in Cosmetic Ingredient Review, December 14-15, 2015;for the functionally similar read across substance, Glycerol esters of rosin [CAS: 8050-31-5].3 New Zealand White Rabbits were subjected to a 4-h semi-occlusive patch test. 0.5 g test chemical was applied to intact skin, no vehicle was used but test chemical was moistened with distilled water. Animals were observed for up to 72 hours. No erythema or edema was observed in the rabbits during the 72 hour observation period.

Glycerol ester of rosin was considered to be not irritating to rabbit skin.

The above results are further supported by the experimental study summarized in Contact Dermatitis, 1989: 20: 41-50;for the functionally similar read across substance, Dehydroabietic acid[CAS: 1740-19-8]. The study was conducted asa part of the Guinea Pig Maximization assay. 10 female Pirbright White guinea pigs were applied different concentrations of dehydroabietic acid(10%,5% and 1%) to the right flank 1 day prior to the Challenge exposure. The reactions were scored and rated after 24 hours. The intensity of reactions were scored according to the following scale:

0 –no reaction = 0.0; (+) – discrete erythema covering more than half of the test area and considered as a very weak but positive reaction = 0.5; + - distinct confluent erythema covering the whole test area = 1.0; ++ - erythema and swelling restricted to test area = 2.0; +++ - erythema with intense swelling,; infiltration and exudation spreading over the test area = 3.0.

A (+) reaction was considered to be the threshold of irritancy.

The irritant threshold concentration of dehydroabietic acid was greater than 10%.

Hence, dehydroabietic acid can be considered to be not irritating to guinea pig skin when applied in concentrations up to 10%.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach,Resin acids and Rosin acids, ammonium saltswas not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Eye Irritation:

In different studies,Resin acids and Rosin acids, ammonium saltshas been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its functionally similar read across substances, and Glycerol esters of rosin [CAS: 8050-31-5] and Pentaerythrityl Rosinate[CAS: 8050-26-8].The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the ocular irritation potential was estimated forResin acids and Rosin acids, ammonium salts. Resin acids and Rosin acids, ammonium saltswas estimated to be not irritating to the eyes ofNew Zealand Whiterabbits.

This study is supported by the experimental result summarized in International Journal of Toxicology, Vol 17, Issue 4_suppl, pp. 83 - 94, 1998; for thefunctionally similar read across substance,Pentaerythrityl Rosinate[CAS: 8050-26-8].The study was performed according to Draize method.10% pentaerythriol rosinate in mineral oil (volume not specified) was instilled in to the conjunctival sac of 3 rabbits. The eyes were not rinsed and no anaesthesia was used throughout the study. The reactions were scored at 1, 2, 3 days after instillation according to Draize method. Maximum score = 110.

At day 1, all three rabbits had conjunctival scores of 2/20. The irritation persisted until day 2 in one of the three rabbits. No other signs of irritation were noted. The total and average scores for the test were 2/110 for day 1, 1/110 for day 2, and 0 for day 3.

Since the scores were zero and effects were completely resolved by day 3, it can be considered that Pentaerythrityl Rosinate was not irritating to rabbit eyes.

These studies are further supported by the experimental study summarized in International Journal of Toxicology, 2004; 23 Suppl 2:55-94; for thefunctionally similar read across substance,Glycerol esters of rosin [CAS: 8050-31-5]. 0.1ml of Purified Ester Gum 2 Octyldodecyl Myristate (contains 50% Glyceryl Rosinate and 50% Glyceryl octyldodecyl myristate) was instilled in the conjuctival sac of 6 New Zealand White Rabbits. The untreated eyes acted as controls. Eyes were not rinsed for up to 24 hours post instillation. Ocular reactions were scored at 24, 48, 72 hours post instillation according to Draize Scale (maximum total score -110)

At 72 hours an average score of 0 was reported. Hence, Glycerol esters of rosin was considered to be not an ocular irritant.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach,Resin acids and Rosin acids, ammonium saltswas not irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Available data for Resin acids and Rosin acids, ammonium salts suggests that it is not likely to cause any irritation to eyes and skin.

Resin acids and Rosin acids, ammonium salts can be classified under the category “Not Classified” as per CLP regulation.