Resin acids and Rosin acids, esters with trimethylolpropane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

In vivo study OECD 406

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

Acceptable guinea pig maximisation test that followed sound scientific principles.

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, esters with trimethylolpropane

EC Number:

284-009-7

EC Name:

Resin acids and Rosin acids, esters with trimethylolpropane

Cas Number:

84776-83-0

Molecular formula:

UVCB substance - Molecular formula Not applicable for UVCBs

IUPAC Name:

Resin acids and Rosin acids, esters with trimethylolpropane

Test material form:

solid

Details on test material:

Vapour pressure: less than 1.4 x 10-3 Pa at 25 °C
Water solubility: 0.06.09x10-4 kg/m-4 g/l
Density: 1.07 x10³ kg/m³ at 19.8 ∓ 0.5 °C
Appearance: pale yellow solid
Melting point: 24.2 to 51.2 ± 0.5 °C (297 to 324 ± 0.5 K)
Boiling point: 418 ± 0.5 °C (691 ± 0.5 K) at 100.9 kPa.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Test material name: Ester of tall oil rosin
- CAS 84776-83-0
- Product Test Name: Bevilite 62-85
- Batch Number: 610496
- Appearance: Brittle sold
- Received: 20/05/1987
- Storage: Ambient temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Number of females: 40
- Identification: by ear tattoo

- Acclimation: performed in the lab - no additional details
- House: In suspended caged with wire mesh floors
- Water: Free access
- Diet: ad libitum - Vitamine C-enriched Guinea-Pig Diet F.D.1 (Special Diet Service Limited). Hay was given once weekly.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Concentration / amount:

7.5% w/w in piquid paraffin

Day(s)/duration:

24, 48,72 %

Adequacy of induction:

highest technically applicable concentration used

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Concentration / amount:

10% and 5% w/w in liquid paraffin

Day(s)/duration:

24 hr

Adequacy of challenge:

not specified

No. of animals per dose:

20

Details on study design:

TEST ANIMALS:
Number: 20 (from Number 4300 to 4319)

PRELIMINARY INVESTIGATIONS
The intradermal and topical irritancy of a range of dilutions of ester of tall oil rosin was investigated to identify:
- irritant test substance concentrations suitable for the induction phase of the main study
- non – irritant concentrations by the topical route of administration for the challenge phase

The following concentrations of ester of tall oil rosin were selected:
- Induction:
*Intradermal injection: 7.5% w/w in liquid paraffin
*Topical application: 30% w/w in liquid paraffin
- Challenge
* 10% and 5% w/w in liquid paraffin
PROCEDURE
The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pif maximisation test described by B. Magnusson and A.M Kligman (1970) in “Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens”.
The procedure consists of 2 parts: Induction and challenge.
INDUCTION
A 4x6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of air with electric clippers. Three pairs of intradermal injections were made simultaneously into this area.
1. Freund’s complete adjuvant was diluted with an equal volume of water for irrigation.
2. Ester of tall oil rosin, 7.5% w/w in liquid paraffin
3. Ester of tall oil rosin, 7.5% w/w in 50:50 mixture of Freund’s complete adjuvant and liquid paraffin.
TOTAL APPLICATION
One week after the injection, the same 4x6 cm intrascapular area was clipped and shaved free of hair.
A 2x4 cm patch of Whatman No. 3 paper was saturated with ester of tall oil rosin 30% w/w in liquid paraffin. The patch was placed on the skin and covered ny a length of impermeable plastic adhesive tape (5cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with impervious plastic adhesive tape. The dressing was left in place for 48 hr.
CONTROL ANIMALS
During the induction period the control animals were treated similarly to the test animals with exception that the test compound was omitted from the intradermal injections and topical application.
CHALLENGE
The test and control animals were challenged topically two weeks after the induction period using ester of tall oil rosin 10% and 5% w/w in liquid paraffin.
Hair was removed by clipping and the shaving from an area on the left flank of each guinea-pig. A 2x2 cm patch of Whatman N 3 was saturated with approximately 0.2 ml of ester of tall oil rosin 10% w/w in liquid paraffin and applied to an anterior site on the flank. The test material 5% w/w in liquid paraffin was applied in a similar manner to a posterior site. The patched were sealed to the flank for 24 hours under strips covered by Elastoplast would round the trunk and secured with Sleek.
READING CHALLENGE REACTION
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patched.
Reactions were scored as follows:
- No erythema=0
- Slight erythema=1
- Well defined erythema-2
- Moderate erythema=3
- Severe erythema= to slight eschar formation (injuries and depth) =4

Oedema formation:
- No oedema= 0
- Slight oedema= 1
- Well defined oedema= 2
- Moderate oedema= 3
- Severe oedema= 4

INTERPRETATION OF THE RESULTS
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in the control animals, the results for that test was classified as inconclusive.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group.

Positive control substance(s):

yes

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10% and 5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Not reported

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10% and 5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Not reported

Remarks on result:

positive indication of skin sensitisation

Results 3

Key result

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

10% and 5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Not reported

Remarks on result:

no indication of skin sensitisation

Results 4

Key result

Reading:

1st reading

Hours after challenge:

72

Group:

negative control

Dose level:

Freund's treated controls

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 5

Group:

positive control

Remarks on result:

other: Not specified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals. The test material was not considered to have a sensitisation potential.

Executive summary:

The intradermal and topical irritancy of a range of dilutions of ester of tall oil rosin was investigated to identify the irritant test substance concentrations suitable for the induction phase of the main study and the non – irritant concentrations by the topical route of administration for the challenge phase.

The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximisation test described by B. Magnusson and A.M Kligman (1970) in “Allergic Contact Dermatitis in the Guinea-Pig: Identification of contact allergens”.

The procedure consisted of 2 parts: Induction and challenge.

A 4x6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of air with electric clippers. Three pairs of intradermal injections were made simultaneously into this area.

1. Freund’s complete adjuvant was diluted with an equal volume of water for irrigation.

2. Ester of tall oil rosin, 7.5% w/w in liquid paraffin

3. Ester of tall oil rosin, 7.5% w/w in 50:50 mixture of Freund’s complete adjuvant and liquid paraffin.

One week after the injection, the same 4x6 cm intrascapular area was clipped and shaved free of hair.

A 2x4 cm patch of Whatman No. 3 paper was saturated with ester of tall oil rosin 30% w/w in liquid paraffin. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (5cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with impervious plastic adhesive tape. The dressing was left in place for 48 hr.

During the induction period the control animals were treated similarly to the test animals with exception that the test compound was omitted from the intradermal injections and topical application.

The test and control animals were challenged topically two weeks after the induction period using ester of tall oil rosin 10% and 5% w/w in liquid paraffin.

Hair was removed by clipping and the shaving from an area on the left flank of each guinea-pig. A 2x2 cm patch of Whatman N 3 was saturated with approximately 0.2 ml of ester of tall oil rosin 10% w/w in liquid paraffin and applied to an anterior site on the flank. The test material 5% w/w in liquid paraffin was applied in a similar manner to a posterior site. The patched were sealed to the flank for 24 hours under strips covered by Elastoplast would round the trunk and secured with Sleek.

The challenge sites were evaluated 24, 48 and 72 hours after removal of the patched.

Based on the results of the study, the dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals. There was no evidence of delayed contact hypersensitivity seen in 18 animals.