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Diss Factsheets

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:
supporting study
Study period:
28th January 1987 - 20th March 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: the protocol of Guillot-Gonnet-Clément-Brulos published by the AFNOR: FD n° T03-300
Deviations:
no
Principles of method if other than guideline:
Guinea-pig maximisation test.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea-pig maximisation study was conducted prior to LLNA methodology availability.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Various
- Females nulliparous and non-pregnant:[yes
- Weight at study initiation: 300 to 500 g
- Housing: Polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days before the begining of treatment
- Indication of any skin lesions: none.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 to 70% RH
- Photoperiod (hrs dark / hrs light): a 12-hour light-dark cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.2% w/v at 0.5 mL
Day(s)/duration:
Initial application
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% w/v in 0.5 mL
Day(s)/duration:
Every 48 hours following initial application for a total of 7 applications.
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.2% w/v at 0.5 mL
Day(s)/duration:
48 hours
No. of animals per dose:
10/sex
1/sex untreated.
Details on study design:
RANGE FINDING TESTS: A minimum of one treated group of 2 males and 2 females were dosed 0.5 mL (this being the maximum quantity applicable under an occlusive patch) of concentrations of 100% and 0.2% w/v in water . Two concentrations per animal were administered to clipped skin on the dorsal area for 48 hours and kept in contact with the skin under an occlusive patch. The substance was applied once and cutaneous examinations were carried out 6, 24 and 48 hours after removal of the patches.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 7 exposures.
- Exposure period: 48 hours.
- Test groups: 1 test group
- Control group: 1 control group
- Site: clipped upper thoracic region, just behind the right scapulum.
- Frequency of applications: every 48 hour
- Concentrations: 0.5 mL

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: untreated region of the abdominal lateral region.
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 6, 24 and 48 hours after removal of the occlusive patch.

Challenge controls:
Untreated animal served as controls because the substance was used as supplied (i.e. no vehicle).
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
6
Group:
test chemical
Dose level:
5% w/v challenge
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
None.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% w/v challenge
No. with + reactions:
0
Total no. in group:
17
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% w/v challenge
No. with + reactions:
0
Total no. in group:
17
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance at 5% w/v not produce any cutaneous sensitising reaction (nil or very weak) in 19 out of 20 animals in the guinea pig maximisation test.
Executive summary:

In an amended guinea pig maximisation test to evaluate the sensitisation potential of the substance male and female mice (ten animals/sex) were exposed (occlusive) topically to the substance at 0.2% w/v in water during first application followed by 7 topical (occlusive) applications at 5% w/v in water every 48 hours. Following a resting period of 12 days a challenge application was administered topically for 48 hours employing 0.2% w/v in water at 0.5 mL a site away from the site of initial induction. The skin site was monitored for any signs of irritation at 6, 24 and 48 hours post-application. A skin biopsy was taken from those animals in which irritation was observed at 6 hours following the challenge application. Macroscopic and histological evaluations were conducted on these tissues. No other animals exibited signs of irritation for the remainder of the study. Macroscopic and histological evaluations were conducted on these tissues as well. The findings indiacte that the substance is not a skin sensitiser or is a weak sensitiser as reported by the study facilitator.