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Diss Factsheets

Administrative data

Description of key information

The skin sensitisation potential of the test item on guinea pigs was determined in a GLP study comparable to OECD 406. It is concluded that repeated administration of Sucralose does not cause delayed contact hypersensitivity in guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-07-26 until 1986-08-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No information was provided on positive controls (sensitivity and reliability should be assessed every six months).
Justification for type of information:
A guinea pig maximization test is provided to fill this endpoint, as the LLNA test was not a standard method in 1986. The study was performed following a standard protocol under GLP and is of sufficient quality. No indication of human skin irritation or sensitization potential has been reported during 30 years of widespread use of the substance as sweetener.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive controls data reported
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA test was not a standard method in 1986.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: From sponsor; Batch No. 163003
- Expiration date of the lot/batch: not specified
- Purity test date: 99.4%; date not provided

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 degrees C, protected from light
- Stability under test conditions: Identity, homogeneity and stability of test material in selected vehicle was the responsibility of the Sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: Identity, homogeneity and stability of test material in selected vehicle was the responsibility of the Sponsor.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test material was prepared at appropriate concentrations in distilled water and/or Freunds Complete Adjuvant (FCA).

FORM AS APPLIED IN THE TEST (if different from that of starting material)
Test material was prepared at appropriate concentrations in distilled water and/or Freunds Complete Adjuvant (FCA).
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Animal Breeding Ltd., Heathfield Sussex
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Bred under hygienic conditions; Examined on delivery and found to be in good state of health.
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 275-381 grams
- Housing: 56 x 38 x 18 cm high density polypropylene cages with stainless steel grid floors and tops
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days
- Indication of any skin lesions: None

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23 degrees C
- Humidity (%): 55%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
- IN-LIFE DATES: From: 26 June 1986 To: 2 August 1986
Route:
other: Intradermal-anterior sites
Vehicle:
water
Concentration / amount:
Freunds Complete Adjuvant (FCA) diluted in water
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
other: Intradermal-middle sites
Vehicle:
water
Concentration / amount:
30% w/v Sucralose
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
other: Intradermal-posterior sites
Vehicle:
other: Freunds Complete Adjuvant (FCA)
Concentration / amount:
10% w/v Sucralose 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:
water
Concentration / amount:
50% (w/v) of Sucralose / 0.6mL
Day(s)/duration:
Day 8 / 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50% w/v / 0.03ml applied to right flank
Day(s)/duration:
Day 22 / 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 per sex for the test group
10 per sex for the control group
Details on study design:
RANGE FINDING TESTS:
-Intradermal injection: Four guinea pigs injected with single intradermal injections of 1%, 3%, 5%, 10% and 30% w/v Sucralose in distilled water in two animals or 1%, 3%, 5%, and 10% w/v Sucralose in FCA in the other two animals. Reactions were assessed approximately 24 and 48 hours after injection.
-Topical application: Five guinea pigs were subject to single intradermal injection of FCA at least 3 days prior to administration of test material. Two were used to ascertain the maximum tolerable concentration of tesst material and three to determine the maximum non-irritant concentration of test material following occluded application to the skin.
-First phase: 0.03 ml topical application of 5%, 10%, 30% and 50% w/v Sucralose in distilled water to 4 sites each on two guinea pigs. Occulsive application for 24 hours.
-Second phase: Repeated by using three guinea pigs to assess the irritancy of 5%, 10%, 30% and 50% w/v Sucralose in dstilled water.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two; Intradermal on Day 1 and Epicutaneous on Day 8
- Exposure period: 48 hours for epicutaneous occlusive patch on Day 8
- Test groups: FCA; For Intradermal: 30% w/v Sucralose in distilled water; 10% w/v TGS in FCA; For epicutaneous/topical: 50% w/v Sucralose in water
- Control group: FCA; Distilled Water; Distilled water in FCA
- Site: Dorsal median line parallel to spinal column (anterior, middle, posterior)
- Frequency of applications: Day 1 (3 injections); Day 8 (topical)
- Duration: Topical-48 hours
- Concentrations: For Intradermal: 30% w/v Sucralose in distilled water; 10% w/v TGS in FCA; For epicutaneous/topical: 50% w/v Sucralose in water

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: All
- Control group: Water
- Site: Flanks of animals trunk
- Concentrations: 50% w/v Sucralose in water
- Evaluation (hr after challenge): 24
Challenge controls:
0.03 ml distilled water
Positive control substance(s):
no
Positive control results:
not indicated
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% w/v Sucralose in water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slight patchy erythema (score of +/-) in 2 animals; Controls had similar response
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% w/v Sucralose in water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slight patchy erythema (score of +/-) in 2 animals; Controls had similar response
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% Distilled Water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
slight patchy erythema (score of +/-) in one animal
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% Distilled Water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: naive control
Dose level:
50% w/v sucralose in water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
one animal with patch erythema (score of +/-)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: naive control
Dose level:
50% w/v sucralose in water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
one animal with patchy erythema (score of +/-)
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitisation potential of the test item on guinea pigs was determined in a GLP study comparable to OECD 406. It is concluded that repeated administration of Sucralose does not cause delayed contact hypersensitivity in guinea pigs.
Executive summary:

The potential of Sucralose to cause delayed contact hypersensitivity in guinea pigs was assessed by the Magnusson-Kligman Maximisation test. The shaven dorsa of ten male and female Dunkin-Hartley guinea pigs were subject to intradermal injections of Freunds Complete Adjuvant, 30% w/v Sucralose in distilled water, or 10% Sucralose in the adjuvant on day 1. Seven days later the same area of skin was treated by occlusive topical application of 50% w/v Sucralose in distilled water for 48 hours. The control group received the same treatment except that test material was replaced by vehicle in all cases. On day 22 all animals were challenged by occluded application of distilled water to the right flank and 50% TGS in distilled water to the left flank for 24 hours. No significant dermal responses were observed in any test or control group animal following challenge application of 50% w/v Sucralose in water. Therefore, the test substance was determined to not elicit delayed contact hypersensitivity in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential of Sucralose to cause delayed contact hypersensitivity in guinea pigs was assessed by the Magnusson-Kligman Maximisation test. The shaven dorsa of ten male and female Dunkin-Hartley guinea pigs were subject to intradermal injections of Freunds Complete Adjuvant, 30% w/v Sucralose in distilled water, or 10% Sucralose in the adjuvant on day 1. Seven days later the same area of skin was treated by occlusive topical application of 50% w/v Sucralose in distilled water for 48 hours. The control group received the same treatment except that test material was replaced by vehicle in all cases. On day 22 all animals were challenged by occluded application of distilled water to the right flank and 50% TGS in distilled water to the left flank for 24 hours. No significant dermal responses were observed in any test or control group animal following challenge application of 50% w/v Sucralose in water. Therefore, the test substance was determined to not elicit delayed contact hypersensitivity in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments), the test substance should not be classified for skin sensitisation.