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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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Additional to an LLNA study with the test substance, a valid guinea pig maximization study with the read-across substance, CAS 68516-73-4, is available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Yellow powder
Specific details on test material used for the study:
- Lot/batch No.: 201P69495
- Expiration date of the lot/batch: 22-MAY-2005
- Stability under test conditions: stable
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: 4 - 6 weeks at delivery
- Weight at study initiation: 300 - 359 g
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (air conditioned room)
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2001-07-03 To: 2001-08-03

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
10% (intradermal)
30% (epicutaneous)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
10% (intradermal)
30% (epicutaneous)
No. of animals per dose:
10 test group
5 control group
Details on study design:
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 30% in PEG 300 one week after the intradermal induction. The animals of the control group were intradermally induced
with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10% in PEG 300 and PEG 300 alone under occlusive dressing.
Challenge controls:
CONTROL GROUP
TONER YELLOW 3GP, 10% in PEG 300 (left flank)
PEG 300 only (right flank)

TEST GROUP
TONER YELLOW 3GP, 10% in PEG 300 (left flank)
PEG 300 only (right flank)
Positive control substance(s):
yes
Remarks:
2-MERCAPTOBENZOTHIAZOLE

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none

Any other information on results incl. tables

Challenge with vehicle only caused no skin reactions in the control group and test group, respectively.

CONTROL GROUP

No skin reactions were observed in the animals when treated with either PEG 300 only or when treated with the test item at 10% in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch.

TEST GROUP

No skin reactions were observed in the surviving animals when treated with either PEG 300 only or when treated with the test item at 10% in PEG 300. Yellow discoloration produced by the test item was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.

The body weight of the animals was within the range commonly recorded for animals of this strain and age. No clinical signs were observed. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.

One animal died during the study. No cause of death could be identified and no skin reactions were observed. The death is considered to be incidental.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met