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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-07-11 to 2000-08-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Zinn(II)-ricinoleat
IUPAC Name:
Zinn(II)-ricinoleat
Constituent 2
Reference substance name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
EC Number:
700-814-2
Molecular formula:
not applicable UVCB substance
IUPAC Name:
Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Species : Dunkin Hartley strain, albino guinea pig (SPF-quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EC).
Source : Charles River Deutschland, Kisslegg, Germany.
Number of animals : Experimental group: 10 females. Control group: 5 females (females were nulliparous and non-pregnant).
Age : Young adult animals (approx. 4 weeks old) were selected.
Identification : Ear tattoo.
Reliability check : The results of a reliability test performed not more than 6 months previously are summarised in the Appendix. Similar procedures were used in the reliability test and in this study.
Conditions : A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21°C, a relative humidity of 50% and 12 hours artificial fluorescent light and 12 hours dark per day. Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
Accommodation : Group housing of 5 animals per labelled metal cage with wire-mesh floors. The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions.
Diet : Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg); (Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, Lage, Germany). Certificates of analysis were examined and retained in the NOTOX archives. Hay (B.M.I., Helmond, The
Netherlands) was provided once a week.
Water : Free access to tap water. Certificates of quarterly analysis for tap-water were examined and retained in the NOTOX archives.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
1 % in corn oil for intradermal induction, 20 % for the epidermal challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1 % in corn oil for intradermal induction, 20 % for the epidermal challenge
No. of animals per dose:
Experimental group: 10 females.
Control group: 5 females.
Details on study design:
INDUCTION - Experimental animals:
Day 1 : The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
A) A 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.) with water for injection (Fresenius AG, Bad Homburg, Germany).
B) The test substance at a 1 % concentration.
C) A 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant.
Note: One of each pair was on each side of the midline and from cranial A) to caudal C).
Day 3 : The dermal reactions caused by the intradermal injections were assessed for irritation.
Day 8 : The scapular area between the injection sites was clipped and subsequently treatedwith 0.5 ml of a 100% test sUbstance concentration using a Metalline patch (2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance using water and the dermal reactions caused by the epidermal exposure were assessed for irritation.
INDUCTION - Control animals:
The control animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administered.
CHALLENGE - All animals:
Day 22 : One flank of all animals was clipped and treated by epidermal application of a 20% test substance concentration and the vehicle (0.15 ml each), using Patch Test Plasters (Leukotest ®, Beiersdorf Medical, Almere, The Netherlands). The patches were held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 24 hours exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.

Grading Irritation Reactions:
Erythema and eschar formation:
No erythema 0
Slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:
No oedema 0
Slight oedema (barely perceptible) 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
(Intradermal reactions were assessed for erythema only or, if necrosis is present the diameter of necrosis.)

Grading Challenge Reactions:
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Moderate erythema and swelling 3
Intense erythema and swelling 4

Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMIC ALDEHYDE was tested in an independent study as reliability check of the test system

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Challenge readings:

 

Animal number

Day 24

Day 25

Comments

20 % *

Vehicle **

20 % *

Vehicle **

 

Control

 

 

 

 

 

51

0

0

0

0

 

52

0

0

0

0

 

53

0

0

0

0

 

54

0

0

0

0

 

55

0

0

0

0

 

Experimental

 

 

 

 

 

56

1

0

1

0

sensitized

57

1

0

1p

0

sensitized

58

2

0

1

0

sensitized

59

2

0

2p

0

sensitized

60

1

0

1

0

sensitized

61

1

0

2

0

sensitized

62

1

0

1

0

sensitized

63

1

0

1

0

sensitized

64

1

0

1

0

sensitized

65

2

0

2p

0

sensitized

* test substance concentration

** corn oil

P = scaliness

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The skin reactions observed in response to a 20% test substance concentration in all (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 100 per cent.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), ZINN(II)-RICINOLEAT should be labelled as: may cause sensitisation by skin contact (R 43).
Executive summary:

Assessment for Contact Hypersensitivity to ZINN(II)-RICINOLEAT in the Albino Guinea Pig (Maximisation Test).

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens". Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 1 % concentration and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). Two weeks after the epidermal application all animals were challenged with a 20% test substance concentration and the vehicle. In the challenge phase, skin reactions varying between grades 1 and 2 were observed in all experimental animals in response to the 20% test substance concentration. No skin reactions were evident in the control animals. Scaliness was seen in some treated skin sites among the experimental animals. The skin reactions observed in response to a 20% test substance concentration in all (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 100 per cent.