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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 - 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17-07-1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was performed already in 2002.

Test material

Constituent 1
Specific details on test material used for the study:
Identity: ISOPROPYL N-LAUROYLSARCOSINATE
Description: pale yellow liquid
Batch number: 002013
Purity: 92.9 %
Stability of test item: stable under storage conditions
Expiry date: 31-03-2003

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
Test system: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
Rationale: Recognized by the international guidelines as a recommended test system
Source: RCC Ltd., Füllinsdorf / Switzerland
Number of animals for main study / pretests: 15 males / 7 males
Age at pretest start/beginning of acclimatization period: 4 – 6 weeks
Body weight at pretests start: Pretest groups: 373 – 403 g
Body weight at beginning of acclimatization period: Control and test group: 354 – 413 g

Acclimatization: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretests. Only animals without any visible signs of illness were used for the study.
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 +/- 3°C and for relative humidity between 30-70 %. 12 hours fluorescent light/12 hours dark, music during the light period.
Accommodation: Individually in Makrolon type-4 cages
Diet: Pelleted standard Provimi Kliba 3418 ad libitum
Water: Community tap-water

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
Induction Concentration: 100 %
0.1 mL of 50 % of the test item in FCA
Day(s)/duration:
day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
0.1 mL of undiluted test item under occlusive dressing
Day(s)/duration:
day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
Two patches of filter paper were saturated with the test item at the highest tested non-irritating concentration of 0.5 %. The volume of vehicle and test item preparation applied was approximately 0.2 mL.
Day(s)/duration:
day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test group: 10
Control group: 5
Details on study design:
Dose selection for the main study
lntradermal and Epidermal lnduction: The concentration of test item used for each induction exposure was well-tolerated systemically and was the highest to cause mild-to-moderate skin irritation.
Epidermal Challenge: Concentration that was the maximum tested non-irritant concentration. To determine the different concentrations one intradermal and three epidermal pretests were performed.

Interpretation
The results obtained from test animals following the challenge application were compared with the results seen in control animals.
An allergic reaction was defined by visible reddening of the challenge site.
If the dermal reactions of test animals following the challenge were more marked and/or persistent than those of the control animals, the animals were considered to show evidence of contact hypersensitivity.
If the dermal reactions of test animals following the challenge were not clearly different from the reactions seen in the control group animals, the results for the test animals were considered "inconclusive".
The test animals were considered to show no evidence of contact hypersensitivity if the dermal reactions to the challenge application were identical or less marked and/or persistent than the reactions observed in the control animals.
By "maximizing" the exposure and enhancing allergenicity, some problems could arise, particularly in relation to specificity, especially the potential for false-positive reactions. An inflammatory response at challenge may not necessarily be due to allergenicity, but instead may be a false-positive irritant response caused by an inducing hyperirritability.

Observations
Viability / Mortality: Daily from delivery of the animals to the termination of the test
Clinical signs (systemic): Daily from delivery of the animals to the termination of the test
Skin reactions: At the times specified during the pretests, induction and challenge periods
Body weights: At pretest I, II, III and acclimatization start, on test days 1, 8 (test item treatment start in the pretest II), 18 (test item treatment start in the pretest III) and termination of the test.
No necropsies were performed in the animals of the epidermal pretest II, III, control and test group sacrificed at termination of the observation period nor in the animals of the intradermal and epidermal pretest I sacrificed on test day 1 of the main study.
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 chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
None of the control and test animals showed skin reactions after the challenge treatment with the test item at 0.5 % (w/w) in PEG 300.
Executive summary:

In order to assess the cutaneous allergenic potential of the test item, the Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs according to OECD GL 406. The intradermal induction of sensitization in the test group was performed in the nuchal region with the undiluted test item and an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item 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 lest animals were challenged by epidermal application of the test item at 0.5 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No toxic symptoms were evident in the guinea pigs of the control or test group and no deaths occurred. None of the control and test animals showed skin reactions after the challenge treatment with the test item at 0.5 % (w/w) in PEG 300.