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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 July 2002 to 17 February 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline- and GLP-compliant; No data on Buehler tests with positive control substances are given in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study report other than LLNA method was available before REACH entry into force. Additional animal testing was omitted for reasons of animal welfare.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Resin 835 A (Lot:0141762)
- Molecular formula (if other than submission substance): main component C20H28O2
- Molecular weight (if other than submission substance): main component 300 g/mol
- Physical state: solid
- Composition of test material, percentage (w/w) of components: 52 % dehydroabietic acid, 47.2 % partially hydrogenated rosin
- Purity test date: 1 July 2002
- Lot/batch No.: 0141762
- Expiration date of the lot/batch: 5 June 2003
- Stability and homogeneity in the vehicle: guaranteed for 4 hours in sesame oil
- Storage condition of test material: at approx. 20 °C in a fume cupboard

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Mol:DH (Moellegaard)
Sex:
female
Details on test animals and environmental conditions:
- Source: M & B A/S, P.O. bos 1079, 8680 Ry, Denmark
- Weight at study initiation: mean 334.8 g, min 270 g, max 361 g
- Housing: 5 animals per cage, Makrolon type IV, on soft wood granulate
- Diet (e.g. ad libitum): ssniff Ms-H (V 2233), ad lib.
- Water (e.g. ad libitum): tap water, ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
100 %: 0.5 g test substance moistened with 0.2 mL sesame oil per animal and per administration (induction and challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
100 %: 0.5 g test substance moistened with 0.2 mL sesame oil per animal and per administration (induction and challenge)
No. of animals per dose:
- 10 in the control group
- 20 in the treatment group
Details on study design:
RANGE FINDING TESTS:
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was administered to the flanks of guinea pigs:

Animal No. Left flank Right flank
1 100 % (moistened) 20 % in sesame oil
2 100 % (moistened) 4 % in sesame oil
3 20 % in sesame oil 4 % in sesame oil

The hair on the flanks of the animals was removed mechanically. 0.5 mL or 0.5 g of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 6 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and edema according to the scale Draize.

No signs of irritation occurred after administration of the different test concentrations. Based on these results, 100 % Resin 835 A (Lot: 0141762) was selected for the sensitization treatments.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Test groups: 20 animals
- Control group: 10 animals (sesame oil)
- Site: left flank, front part
- Frequency of applications: 1/week
- Duration: 6 h
- Concentrations: 100 % (0.5 g test substance moistened with 0.2 mL sesame oil)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 (day 30)
- Test groups: 20 animals
- Control group: 10 animals (sesame oil)
- Sites: test substance: right flank hind part; vehicle: right flank front part
- Concentrations: 100 % (0.5 g test substance moistened with 0.2 mL sesame oil)
- Evaluation (hr after challenge): 48 and 72 h (i.e. 24 and 48 h after removal of the patches)
Challenge controls:
10 animals were treated identically to the treatment group animals.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: not applicable. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: not applicable. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the present study, none of twenty animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study Resin 835 A (Lot: 0141762) showed no evidence for sensitizing properties according to the classification criteria of Directive 2001/59/EC.
Executive summary:

Skin sensitization testing of Resin 835 A (Lot: 0141762) was performed in female guinea pigs according to the method of BUEHLER.

Dermal induction was performed using 100 % Resin 835 A (Lot: 0141762) 0.5 g moistened with 0.2 mL in sesame oil. The control group was exposed to sesame oil only. Challenge treatment was carried out with 100 % Resin 835 A (Lot: 0141762) 0.5 g moistened with 0.2 mL in sesame oil.

The validity of the test system is confirmed by the periodically conducted positive control test using Alpha-hexylcinnamaldehyde for the maximization test (report number PT02-0041, dated 13 -Jun-2002; Aventis Pharma Deutschland GmbH, ProTox).

Based on the results of this study Resin 835 A (Lot: 0141762) showed no evidence for sensitizing properties according to the classification criteria of Directive 2001/59/EC.