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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986-11-12 to 1986-12-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study with acceptable restrictions The following deviations from the guideline occurred: - the animals were only observed 24 hours after challenge. The 48 hour observation was not conducted during the study. - the Magnusson and Kligman scale was slightly modified. The scale included a 0.5 value (slightly patchy erythema), which is normally not included in the scale. This was the only value recorded during the observation period. - study design did not included a positive control

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Tin (II)-methane sulphonate (supplied by Riedel de Haen AG, Seelze)
- Physical state: white, fine-grained powder
- Storage condition of test material: in darkness, normal room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS - Hoe:DHPK (SPF - LAC.)/Boe.
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Hamelner Straße 3, 4923 Extertal 1
- Weight at study initiation: 300 - 382 g
- Housing: max. 5 animals in one cage; Macrolon plastic cages IV, 20 cm high, 33 cm width, 55 cm length; bedding material: H-3/4 (producer: Hahn & Co., Bredenbeck); Production: from pure soft wood, dried, dust free and sterilized
- Diet (ad libitum): Ssniff-G (Alleindiät für Meerschweinchen) (producer: Ssniff Spezialdiäten GmbH); pellets, 1.0 cm large, 0.5 cm diameter
- Water (ad libitum): aqua fontana as for human consumption
- Acclimation period: 7 days at least

ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C ± 2°C
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal: 0.25% of the test substance
Topical induction: 1% of the test substance
Challenge: 1% of the test compound
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal: 0.25% of the test substance
Topical induction: 1% of the test substance
Challenge: 1% of the test compound
No. of animals per dose:
10 males / 10 females
Details on study design:
Prior to treatment the shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm).

RANGE FINDING TESTS:
To exclude primary skin irritations two animals/group were treated dermally in a preliminary study under occlusiv conditions with the following concentrations of the sample: 100% (undiluted), 75%, 25%, 5%, 2.5%, 1% and 0.5% in aqua dest..
Results:
100% (undiluted): 24 hours and partly 48 hours slight erythema
75% in aqua dest.: 24 hours and partly 48 hours erythema (24 hours necrosis 1 animal)
25% and 5% in aqua desti.: 24 hours and 48 hours slight erythema
2.5% in aqua dest.: 24 hours partly slight erythema
1% and 0.5% in aqua dest.: no primary skin irritation

MAIN STUDY
A. INDUCTION EXPOSURE
1) Intradermal treatment
On the day of the experiment all animals of both groups were treated intradermally into two skin areas situated bilateral to the spine. The first injection sites were located at the craniodorsal area and the following onces were performed underneath.

Test group:
Injection 1: 0.25% of test compound in aqua dest.(2 injections)
Injection 2: 0.25% of test compound in FCA (2 injections)
Injection 3: 1:1 FCA diluted in aqua dest. (2 injections)
Control group:
Injection 1: undiluted FCA (2 injections)
Injection 2: 0.25% auqa dest. in FCA (2 injections)
Injection 3: undiluted aqua dest. (2 injections)

2) Topical treatment
7 days later the same sites were treated topically with 0.5 mL of the test sample (test group) and the vehicle (control group), in the maximal concentration which is proved to cause no primary irritation (Range finding). After the application the treated areas were covered with a gauze pad and fixed to the animals trunk with "Elstoplast" (Closed Patch Test). 48 hours post administration the bandage was removed.

B. CHALLENGE EXPOSURE
3 weeks after the first dermal treatment a second dermal treatment was carried out on both test- and control group. The test and control group recieved the test substance on the left clipped flank and the vehicle on the right clipped flank.
The animals were treated again analogously to the 1st dermal treatment for 24 hours.
24 hour post administration the bandages were removed and the first evaluation was conducted.
48 hours post administration the second evaluation was done according to slightly modified Magnusson and Kligman grading scale (please refer table 1 in the "Any other information on materials and methods incl. tables" below)
Challenge controls:
Vehicle control group 10 male/10 female
Challenge dose: 1% of the test compound
Positive control substance(s):
no

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% of the test substance in aqua dest.
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
(±) Slight patchy erythema (grade 0.5) was observed in 10/20 guinea pigs.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% of the test substance in aqua dest.. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: (±) Slight patchy erythema (grade 0.5) was observed in 10/20 guinea pigs..
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% of the test substance in aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% of the test substance in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Aqua dest.
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Main study:

24 hours and 48 hours after challenge slight erythema were observed at the side treated with the compound in the test group. The control side of the test and control group (right flank) was without any findings.

In the control group partly slight primary skin reaction were observed 24 hours post administration at the test substance side. After 48 hours post adminsitration the concerning animals of this group were again without any findings.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered to be a skin sensitizer. 10/20 (50%) animals showed a positive response.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is a skin sensitizer.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is classified in Category 1.