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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:
15 January 2002 to 15 February 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with GLP regulations.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A scientifically valid Guinea Pig Maximization Test (GPMT) was conducted on the substance before the Local Lymph Node Assay was available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Perfluormethoxypropylvinylether
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Analytical purity: 98%
- Purity test date: 30 November 2000
- Lot/batch no.: Lot 3
- Storage condition of test material: Darkness at approximately 5 °C in a refrigerator under nitrogen atmosphere

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M & B A/S
P.O. Box 1079
DK-8680 Ry
Denmark
- Age at study initiation:
- Weight at study initiation:
- Housing: 5 animals per cage in transparent macrolon (type V) cages.
- Diet (e.g. ad libitum): Ssniff Ms-H (V 2233), ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period:At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 January 2002 To: 15 February 2002

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Tylose
Concentration / amount:
25% test substance in Tylose
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Tylose
Concentration / amount:
25% test substance in Tylose
No. of animals per dose:
There were 10 animals in the treatment group and 5 in the control group.
Details on study design:
Day 1: Intradermal injection, Day 8: 48 hour epicutaneous dermal induction, Day 22: 24 hour epicutaneous dermal challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal induction, 1 epicutaneous induction
- Exposure period: 48 hour epicutaneous induction.
- Test groups: The test article group contained 10 females.
- Control group: The control group contained 5 females.
- Site: Dorsal
- Frequency of applications: 1 intradermal, 1 epicutaneous
- Duration: Day 1: Intradermal injection, Day 8: 48 hour epicutaneous dermal induction, Day 22: 24 hour epicutaneous dermal challenge.
- Concentrations: Intradermal induction: 5% test article in Tylose, Epicutaneous induction: 25% test article in Tylose
B. CHALLENGE EXPOSURE
- No. of exposures: 1 epicutaneous challenge exposure.
- Day(s) of challenge: Study Day 22
- Exposure period: 24 hour epicutaneous challenge exposure
- Test groups: All 10 females in the test group were challenged epicutaneously.
- Control group: All 5 females in the control group were challenged epicutaneously.
- Site: Left flank.
- Concentrations: 25% test article in Tylose
- Evaluation (hr after challenge): 24 hours after removal of the patches.
Challenge controls:
Tylose
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Intradermal injection induction: 0.1 mL of 5% test article in Tylose, Epicutaneous induction and challenge: 0.5 mL of 25% test article in Tylose.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
The body weight gains of the animals were not impaired. Treated animals showed no clinical signs of toxicity throughout the study. No skin reactions were observed in the control and treatment group 24 and 48 hours after removal of the challenge patch.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Intradermal injection induction: 0.1 mL of 5% test article in Tylose, Epicutaneous induction and challenge: 0.5 mL of 25% test article in Tylose.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The body weight gains of the animals were not impaired. Treated animals showed no clinical signs of toxicity throughout the study. No skin reactions were observed in the control and treatment group 24 and 48 hours after removal of the challenge patch..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article showed no evidence for dermal sensitization potential.
Executive summary:

The dermal sensitization potential of the test article was determined in guinea pigs. The study was conducted in accordance with OECD GLP (1999). The test method was based on EU Method B.6 (1996), OECD Guideline 406 (1992), and U.S. EPA: OPPTS:870.2600 (1998). On Study Day 1, female guinea pigs (10, test group) were induced with 0.1 mL of 5% test article in Tylose by intradermal injection in the dorsal region (2x4 cm). A control group (5 female) were exposed in the same manner without the addition of the test article. Two intradermal injections per animal of 50% Freund's Adjuvant, 5% test substance in Tylose, and test article mixture in 50% Freund's Adjuvant were administered. The injection sites were left uncovered. On Study Day 8, the second induction exposure of 0.5 mL of 25% test article in Tylose was administered to a 2 x 4 cm cellulose patch. The patch was placed over the area where the intradermal injections were administered. The exposure area was kept under an occlusive bandage for 48 hours. No treatment was conducted from Study Days 11-21. On Study Day 22, the challenge exposure of 0.5 mL of 25% test article in Tylose was administered on a 2 x 4 cm cellulose patch. The administration area was kept under an occlusive bandage for 24 hours. Approximately 24 and 48 hours after the removal of the patches the exposure area was examined for erythema and edema according the the Magnusson/Kligmann scale. Body weights (Day -1 and Day 25) and clinical signs (Daily) were recorded. The body weight gains of the animals were not impaired. The treated animals showed no clinical signs of toxicity throughout the study. No skin reactions were observed in the control and treatment group 24 and 48 hours after removal of the challenge patch. Based on the results of the study, the test article showed no evidence for dermal sensitization potential.