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Diss Factsheets

Administrative data

Description of key information

4 HMT tests are available according to Kligman, A. M. (1966) method: One study showed a sensitising effect in 3 out of 27 volunteers after testing with 8% Stryrax ABS. RESIN (Epstein, 1976). In the 3 remaining HMT studies, no reactions were observed that were considered significantly allergic after testing with 8% Styrax.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
GLP compliance:
no
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
The study was conducted before REACH came into force and before OECD test guideline 429 was published.
Specific details on test material used for the study:
TEST MATERIAL
STYRAX HONDURAS EX HEXANE 81-8-PROD-1
Species:
other: human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
29 healthy male and female volunteers were screened and 25 completed the study. However results of 24 subjects were presented in the report.

Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8%
Day(s)/duration:
for 5 alternate day 48 hour periods
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: challenge site was not pretreated
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: challenge site was pretreated with 3% sodium lauryl sulfate
No. of animals per dose:
25 volunteers completed the study, results of 24 volunteers are presented in the study report.
Details on study design:
The materials were pretested on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 3% SLS.
The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 3% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 3% aqueous SLS under occlusion without SLS treatment on the right side. Questionable reactions were followed and retests will be applied.

Patch material: Webril cloth
Induction patch 1,5 inch square with 1.0 mL test solution
Challenge patch 1,0 inch square with 0.4 mL test solution
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
8%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: In this study the SLS was not particularly irritating giving burn reactions in about 20% of the subjects.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
not applicable
Interpretation of results:
study cannot be used for classification
Conclusions:
Preparation 81-8-PROD-1, STYRAX HONDURAS EX HEXANE, gave no reactions that were considered significantly allergic or irritant in the 24 subjects tested.
Executive summary:

A Human maximisation test was performed according to the Kligman, 1966 procedure. 29 healthy male and female volunteers were screened and 25 completed the study. However results of 24 subjects were presented in the report. The materials were pretested on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 3% SLS. The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 3% aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 3% aqueous SLS under occlusion without SLS treatment on the right side. Questionable reactions were followed and retests will be applied. In this study the SLS was not particularly irritating giving burn reactions in about 20% of the subjects. Preparation 81-8-PROD-1, STYRAX HONDURAS EX HEXANE, gave no reactions that were considered significantly allergic or irritant in the 24 subjects tested.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
GLP compliance:
no
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
The study was conducted before REACH came into force and before OECD test guideline 429 was published.
Specific details on test material used for the study:
TEST MATERIAL
S-TYRAX ABS. RESIN, 76-8-288
Species:
other: human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
Thirty-five healthy inmate volunteers were screened and twenty-seven completed the study.
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
for 5 alternate day 48 hour periods
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Challenge site was not pretreated.
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Challenge site was pretreated with 5% sodium lauryl sulfate
No. of animals per dose:
27 volunteers completed the study
Details on study design:
The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied with SLS treatment on the left and petrolatum on the right and labelled site 5. Questionable reactions were biopsied and followed daily for 1 week with retest at a separate site at a later time.

Patch material: Webril cloth
Induction patch 1,5 inch square with 1.0 mL test solution
Challenge patch 1,0 inch square with 0.4 mL test solution
Challenge controls:
Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied with SLS treatment on the left and petrolatum on the right and labelled site 5.
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
8%
No. with + reactions:
3
Total no. in group:
27
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
27
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
Not applicable
Interpretation of results:
study cannot be used for classification
Conclusions:
Preparations STYRAX ABS. RESIN sensitized 3 of the 27 subjects tested and should be considered a mild sensitizer.
Executive summary:

A Human maximisation test was performed according to the Kligman, 1966 procedure. The materials were presented on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 5% SLS. The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied with SLS treatment on the left and petrolatum on the right. Questionable reactions were biopsied and followed daily for 1 week with retest at a separate site at a later time. In this study SLS produced a moderate degree of irritation to subjects #5 and 7 who gave definate + allergic reactions at site the site with STYRAX (76-8-288) and 1 subject #25 gave a 1+ allergic reaction at the SLS treated site and a ± reaction at the non SLS treated site. However by biopsy and repeat patch testing it was apparent that he also had become sensitized to the material. Preparations STYRAX ABS. RESIN sensitized 3 of the 27 subjects tested and should be considered a mild sensitizer.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
GLP compliance:
no
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
The study was conducted before REACH came into force and before OECD test guideline 429 was published.
Specific details on test material used for the study:
TEST MATERIAL
STYRAX ALC. SOL. TURKISH IN DEP. 78-8-8283
Species:
other: human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
29 healthy male and female volunteers were screened and 25 completed the study.
Age 20 - 69
Gender: 10 males, 15 females

Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
for 5 alternate day 48 hour periods
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Challenge site was not pretreated
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Challenge site was pretreated with 2% sodium lauryl sulfate
No. of animals per dose:
25 volunteers completed the study
Details on study design:
The materials were presented on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 5% SLS.
The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5.

Patch material: Webril cloth
Induction patch 1,5 inch square with 1.0 mL test solution
Challenge patch 1,0 inch square with 0.4 mL test solution
Challenge controls:
SLS controls were placed on the left and petrolatum on the right and labeled site 5.
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
8%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
The test material produced one irritant reaction in subject #22
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
not applicable
Interpretation of results:
study cannot be used for classification
Conclusions:
No significant reactions were seen except in one subject, the site appeared irritated. It can be concluded that STYRAX ALC. SOL. TURKISH IN DEP. produced one irritant reaction.
Executive summary:

A Human maximisation test was performed according to the Kligman, 1966 procedure. 29 healthy male and female volunteers were screened and 25 completed the study. The materials were presented on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 5% SLS. The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right. No significant reactions were seen except in one subject, the site appeared irritated. It can be concluded that STYRAX ALC. SOL. TURKISH IN DEP. produced one irritant reaction.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
Kligman, A. M. (1966). "The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers". J. Invest. Dermatol. 47: 393–409.
GLP compliance:
no
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
The study was conducted before REACH came into force and before OECD test guideline 429 was published.
Specific details on test material used for the study:
TEST MATERIAL
STYRAX TURKISH EX HEXANE 81-8-PROD-2
Species:
other: human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
30 healthy male and female volunteers were screened and 26 completed the study.

Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
8%
Day(s)/duration:
for 5 alternate day 48 hour periods
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: challenge site was not pretreated.
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Challenge site was pretreated with 3% sodium lauryl sulfate
No. of animals per dose:
26 volunteers completed the study. Results of 25 volunteers are presented in the study report.
Details on study design:
The materials were pretested on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 3% SLS.
The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 3% aqueous SLS under occlusion for the initial patch only.
Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 3% aqueous SLS under occlusion without SLS treatment on the right side.

Patch material: Webril cloth
Induction patch 1,5 inch square with 1.0 mL test solution
Challenge patch 1,0 inch square with 0.4 mL test solution
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
8%
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
other: In this group approximately one-third of the subjects were irritated by SLS. However no other significant reactions were observed.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
not applicable
Interpretation of results:
study cannot be used for classification
Conclusions:
Preparation 81-8-PROD-2, STYRAX TURKISH EX HEXANE, produced no reactions that were considered significantly allergic or irritant in the 25 subjects tested.
Executive summary:

A Human maximisation test was performed according to the Kligman, 1966 procedure. 30 healthy male and female volunteers were screened and 26 completed the study. The materials were pretested on all subjects in order to determine whether sodium lauryl sulfate (SLS) pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-treated with 3% SLS. The materials were applied under occlusion to the same site on the volar aspect of the forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-treated for 24 hours with 3% aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 3% aqueous SLS under occlusion without SLS treatment on the right side. In this group approximately one-third of the subjects were irritated by SLS. However no other significant reactions were observed. One subject #20 failed to receive challenge patches and will be retested in the near future. Preparation 81-8-PROD-2, STYRAX TURKISH EX HEXANE, produced no reactions that were considered significantly allergic or irritant in the 25 subjects tested.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Four human maximisation tests are available and performed according to the Kligman, 1966 procedure. These studies are used in a weigh of evidence approach to determine the sensitising potential of Styrax: 

Reference

Test substance

Method

Participants

conclusion

Epstein, 1976

8% STYRAX ABS. RESIN

HMT, Klingman, 1966 procedure

27

Mild sensitizer (3/27 sensitisation reactions)

Epstein, 1978

8% STYRAX ALC. SOL. TURKISH IN DEP

HMT, Klingman, 1966 procedure

25

Not sensitising

Epstein, 1981

8% 81-8-PROD-1, STYRAX HONDURAS EX HEXANE

HMT, Klingman, 1966 procedure

24

Not sensitising

Epstein, 1981

8% 81-8-PROD-2, STYRAX TURKISH EX HEXANE

HMT, Klingman, 1966 procedure

25

Not sensitising

 Three studies performed with 8% test susbtance showed no reactions that were considered significantly sensitising. The Epstein, 1976 study showed a sensitising effect in 3 out of 27 volunteers after exposure to 8% STYRAX ABS. RESIN. It was concluded that STYRAX ABS. RESIN is a mild sensitiser.

According to ECETOC 2002, classification is given when more than 5% of the volunteers have a positive response therefore Styrax is considered not skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In conclusion, Styrax resinoid oil should not be classified as sensitising according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and according to the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).