Storax (balsam)

Skin sensitisation

Administrative data

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

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

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

Details on test animals or test system and environmental conditions:

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

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: petrolatum

Amount / concentration applied:

8%

Duration of treatment / exposure:

48 hours

Number of animals:

25

Details on study design:

In a pre-test for a human maximization study, a patch of the test material in petrolatum was applied to normal sites on the backs of 25 healthy male and female volunteers for 48 hours under occlusion. The skin irritation of Styrax alcohol soluble Turkish in DEP in a concentration of 8% was evaluated prior to a human maximization test and to determine whether sodium lauryl sulfate pretreatment was necessary.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

<= 0

Reversibility:

other: not relevant

Remarks on result:

no indication of irritation

Remarks:

Styrax alcohol soluble Turkish in DEP in a concentration of 8%

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

<= 0

Reversibility:

other: not relevant

Remarks on result:

no indication of irritation

Remarks:

Styrax alcohol soluble Turkish in DEP in a concentration of 8%

Irritant / corrosive response data:

No skin irritation observed.

Interpretation of results:

GHS criteria not met

Conclusions:

8% Styrax alcohol soluble Turkish in DEP was not irritating to human skin under the conditions of this test.

Executive summary:

In a pre-test for a human maximization study, a patch of the test material in petrolatum was applied to normal sites on the backs of 25 healthy male and female volunteers for 48 hours under occlusion. The skin irritation of Styrax alcohol soluble Turkish in DEP in a concentration of 8% was evaluated prior to a human maximization test and to determine whether sodium lauryl sulfate pretreatment was necessary. No skin irritation observed. 8% Styrax alcohol soluble Turkish in DEP was not irritating to human skin under the conditions of this test.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

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.

Test material

Test material information

Constituent 1

Reference substance name:

Storax (balsam)

EC Number:

232-458-4

EC Name:

Storax (balsam)

Cas Number:

8046-19-3

Molecular formula:

Not applicable, UVCB - NCS

IUPAC Name:

Storax (balsam)

Test material form:

liquid

Details on test material:

CAS 8046-19-3
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Styrax resinoid oil, Styrax oil, Styrax, Storax oil, Storax

Specific details on test material used for the study:

TEST MATERIAL
STYRAX ALC. SOL. TURKISH IN DEP. 78-8-8283

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

8%

Day(s)/duration:

for 5 alternate day 48 hour periods

Adequacy of induction:

not specified

Challenge

Challenge 1

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

8%

Day(s)/duration:

48 hours

Adequacy of challenge:

other: Challenge site was not pretreated

Challenge 2

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

Results and discussion

In vivo (non-LLNA)

Results

Results 1

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

Results 2

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

Results 3

Reading:

1st reading

Group:

positive control

Remarks on result:

not measured/tested

Remarks:

not applicable

Applicant's summary and conclusion

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.