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EC number: - | CAS number: -
- Life Cycle description
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- Endpoint summary
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- Ecotoxicological Summary
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- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 December 2016 to 05 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The substances are structurally similar, both ytterbium compounds are in their +3 oxidation state. As the metal cation governs toxicity, it is concluded that the same effect will be observed.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 80 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Intense erythema was noted in three animals, moderate erythema was noted in five animals and discrete erythema was noted in two animals 24 hours after the first induction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Interpretation of results:
- other: Not sensitising in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the test material is not considered to be a skin sensitiser.
- Executive summary:
The aim of the study was to evaluate the possible sensitisation of the test material using the guinea pig maximisation test. The study was performed in accordance with the standardised guidelines OECD 406 and EU method B.6 under GLP conditions.
According to the results of the pre-tests, the test material was applied to 10 Guinea pigs during the the induction phase (intradermic injection at 20% and topical application at 80%). Induction was followed by a 10-day rest phase.
On day 0 after shearing the scapular zone, three pairs of intradermal injections of 0.1 mL were performed on the scapular zone, including the test material at 20% in physiological saline. On day 7 the scapular zone was brushed with a solution of sodium lauryl sulphate at 10 % in thick Vaseline to create a local irritation and then on day 8 a topical application under occlusive dressing was applied for 48 hours on the injection sites of each animal. The occlusive dressing was removed on day 10 and the treated areas were rinsed with distilled water. The challenge phase was conducted under occlusive dressing for 24 hours and consisted of a single topical application of the test material diluted at 80 % and at 40 % in distilled water. The challenge was applied on day 21, removed on day 22 and then observed on days 23 and 24 (24 and 48 hours after removal respectively).
In the treated group (treatment dose of 80 %), a very slight erythema was noted in 10 % (1/10) of the treated animals 24 hours after the challenge phase.No macroscopic cutaneous reactions attributable to allergy were noted 48 hours after the challenge phase. In the control group (associated with the treatment dose of 80 %), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase. In the treated group (treatment dose of 40 %), no macroscopic cutaneous reactions attributable to allergy were noted after the challenge phase. In the control group (associated with the treatment dose of 40 %), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase.
Under the conditions of this study, the test material does not have to be classified in category 1 as a skin sensitiser, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The rare earth substances are known to give false positives in the LLNA studies. The Maximisation study was therefore deemed to be more appropriate for investigating the skin sensitisation potential of this substance.
Test material
- Reference substance name:
- Ytterbium trifluoride
- EC Number:
- 237-354-2
- EC Name:
- Ytterbium trifluoride
- Cas Number:
- 13760-80-0
- Molecular formula:
- F3Yb
- IUPAC Name:
- Ytterbium(3+) trifluoride
- Test material form:
- solid: particulate/powder
- Details on test material:
- -White powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: YBF1002/16
- Expiration date of the lot/batch: 17 October 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, darkness
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test material was used freshly prepared in physiological saline.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 3 to 4 weeks old
- Weight at study initiation: 303 to 350 g
- Housing: In groups of 3
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 to 70%
- Air changes: At least 10 per hour
- Photoperiod: twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Intradermal and Topical
- Vehicle:
- other: Physiological saline (Intradermal) and Distilled water (Topical)
- Concentration / amount:
- Intradermal: 20 %/ 0.1 mL
Topical: 80 %/ 0.5 mL - Day(s)/duration:
- Intradermal induction took place on Day 0. On Day 8, animals received a topical induction application which was covered for 48 hours.
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- other: Topical
- Vehicle:
- other: Distilled water
- Concentration / amount:
- 80 and 40 % / 1 sample cup
- Day(s)/duration:
- On day 21 the challenge dose was applied for 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 in the negative control, 10 in the treated group.
- Details on study design:
- RANGE FINDING TESTS:
- Determination by intradermal injection of the Maximal Non Necrotizing Concentration (MNNC):
Two animals received a volume of 0.1 mL of the test material, on both sides of the spine, at 4 concentrations: diluted at 80%, 50%, 20% and 10% in physical saline in view to determine the MNNC. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after the injections.
- Determination by topical application of the Pre-Maximal Non Irritant Concentration (Pre-MNIC):
This test, which allowed evaluating the irritancy potential of the test material, defined whether an application of sodium lauryl sulphate would be needed during topical induction phase. The test material was applied on the dorso-lumbar zone of two guinea pigs shorn beforehand, with occlusive dressing for 24 hours, at 4 different concentrations: diluted at 80%, 50%, 20% and 10% in distilled water. After the removal of the occlusive dressing, the treated areas were rinsed with distilled water. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing.
- Determination by topical application of the Maximal Non Irritant Concentration (MNIC):
Three guinea pigs were treated according to the same treatment as animals from group 1 (control) for the induction phase (i.e. physiological saline and distilled water). During the challenge phase, the animals were treated with the test material placed onto the selected treatment sites and covered with an occlusive dressing for a period of 24 hours at 4 different concentrations: diluted at 80%, 50%, 20% and 10% in distilled water. After the removal of the occlusive dressing, the treated areas were rinsed with distilled water. A macroscopic evaluation of the cutaneous reactions was conducted 24 and 48 hours after removal of the occlusive dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Induction:
Day 0: After shearing the scapular zone, three pairs of intradermal injections (ID) of 0.1 mL were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
GROUP 1 (control):
-2 ID: Freund’s Complete Adjuvant diluted at 50 % in physiological saline
-2 ID: physiological saline
-2 ID: a mixture with equal volumes v/v: Freund’s Complete Adjuvant at 50% and physiological saline
GROUP 2 (Treated):
-2 ID: Freund’s Complete Adjuvant diluted at 50 % in physiological saline
-2 ID: test material at 20% in physiological saline
-2 ID: a test mixture in equal volumes v/v: Freund’s Complete Adjuvant at 50% and the test item at 40% in physiological saline
Topical Induction:
Day 7: The scapular zone of all the animals in each group, shorn beforehand, was brushed with a solution of sodium lauryl sulphate at 10% in thick Vaseline, in order to create a local irritation.
Day 8: A topical application under occlusive dressing (25mm x 25mm non-woven swab of 4-layer patch held in contact with the skin by means of 50 mm wide hypoallergenic adhesive tape) for 48 hours was performed on the injection sites of each animal.
GROUP 1 (control): 0.5 mL of distilled water.
GROUP 2 (treated): 0.5 mL of the test material at 80 % in distilled water.
Day 10: The occlusive dressing was removed and the treated areas were rinsed with distilled water.
REST PHASE
The animals of both groups were left for 10 days.
B. CHALLENGE EXPOSURE
Day 21: The experimental procedure of this phase was identical for both groups 1 (Control) and 2 (Treated) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application, under occlusive dressing, was performed during 24 hours:
1 sample cup containing the test material diluted at 80 % (MNIC) and 1 sample cup containing the test item diluted at 40 % in distilled water (1/2 MNIC).
Day 22: The occlusive dressing was removed and the treated areas were rinsed with distilled water.
Day 23: 1st reading time – 24 hours after the patch removal.
Day 24: 2nd reading time – 48 hours after the patch removal.
INTERPRETATION OF RESULTS
The test material will be regarded as a sensitiser if 30% or more of the test animals show a sensitisation response. - Challenge controls:
- No, the experimental procedure of this phase was identical for both groups 1 (Control) and 2 (Treated).
- Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- The number of animals sensitised was ≥ 70%.
Therefore, under the experimental conditions, the reference substance a-Hexylcinnamaldehyde must be classified in category 1 “Skin sensitisation” sub-category 1B in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 80 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Intense erythema was noted in three animals, moderate erythema was noted in five animals and discrete erythema was noted in two animals 24 hours after the first induction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 / 80 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Preliminary studies
- MNNC determination:
Necrosis to slight necrosis was observed in the animals at the tested concentrations of 80 and 50%. 24 hours after the injections, moderate to discrete erythema was observed in the animals at the tested concentrations of 20 and 10 %. The first induction of the Group 2 has been carried out by intradermal injection at the maximal non necrosing concentration of 20 %.
- Pre MNIC determination:
24 hours after the removal of the occlusive dressings, no cutaneous reaction was noted whatever the tested concentration. In view of these results, the concentration selected was 80% for the 2nd induction of the Group 2 and the MNIC determination began at the concentration of 80%.
- MNIC determination:
24 and 48 hours after the removal of the occlusive dressings, no cutaneous reaction was noted whatever the tested concentration. In view of this result, the concentrations selected were 80% (MNIC) and 40% (1/2 MNIC).
Main study
- Induction phase Group 2:
Intense erythema was noted in three animals (3/10), moderate erythema was noted in five animals (5/10) and discrete erythema was noted in two animals (2/10) 24 hours after the first induction. Discrete erythema was noted in four animals (4/10) and dryness of the skin was noted in all the animals (10/10) 24 hours after the second induction.
- Induction phase Group 1:
No cutaneous reaction was noted during the induction phase.
- Challenge phase Groups 1 & 2:
Overall results of the challenge phase with the test material (readings at 24 and 48 hours) are given in Table 1. In the treated group (treatment dose of 80 %), a very slight erythema was noted in 10 % (1/10) of the treated animal 24 hours after the challenge phase. No macroscopic cutaneous reactions attributable to allergy were noted 48 hours after the challenge phase. In the control group (associated with the treatment dose of 80 %), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase.
In the treated group (treatment dose of 40%), no macroscopic cutaneous reactions attributable to allergy were noted after the challenge phase.
In the control group (associated with the treatment dose of 40%), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase.
-Weight evolution
No abnormality was recorded in the body weight gain of both groups.
- Mortality
No mortality was registered during the main test.
Table 1: Macroscopic evaluation (readings at 24 and 48 hours) of cutaneous reactions
Groups |
Reading time |
Concentrations |
Incidence |
% of positive responses≥1 |
% of animal sensitised |
|||
0 |
1 |
2 |
3 |
|||||
Group 1 Control |
24 h |
80 % |
5 |
0 |
0 |
0 |
0 |
- |
48 h |
80 % |
5 |
0 |
0 |
0 |
0 |
- |
|
24 h |
40 % |
5 |
0 |
0 |
0 |
0 |
- |
|
48 h |
40 % |
5 |
0 |
0 |
0 |
0 |
- |
|
Group 2 Treated |
24 h |
80 % |
9 |
1 |
0 |
0 |
10 |
10 |
48 h |
80 % |
10 |
0 |
0 |
0 |
0 |
0 |
|
24 h |
40 % |
10 |
0 |
0 |
0 |
0 |
0 |
|
48 h |
40 % |
10 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the test material is not considered to be a skin sensitiser.
- Executive summary:
The aim of the study was to evaluate the possible sensitisation of the test material using the guinea pig maximisation test. The study was performed in accordance with the standardised guidelines OECD 406 and EU method B.6 under GLP conditions.
According to the results of the pre-tests, the test material was applied to 10 Guinea pigs during the the induction phase (intradermic injection at 20% and topical application at 80%). Induction was followed by a 10-day rest phase.
On day 0 after shearing the scapular zone, three pairs of intradermal injections of 0.1 mL were performed on the scapular zone, including the test material at 20% in physiological saline. On day 7 the scapular zone was brushed with a solution of sodium lauryl sulphate at 10 % in thick Vaseline to create a local irritation and then on day 8 a topical application under occlusive dressing was applied for 48 hours on the injection sites of each animal. The occlusive dressing was removed on day 10 and the treated areas were rinsed with distilled water. The challenge phase was conducted under occlusive dressing for 24 hours and consisted of a single topical application of the test material diluted at 80 % and at 40 % in distilled water. The challenge was applied on day 21, removed on day 22 and then observed on days 23 and 24 (24 and 48 hours after removal respectively).
In the treated group (treatment dose of 80 %), a very slight erythema was noted in 10 % (1/10) of the treated animals 24 hours after the challenge phase.No macroscopic cutaneous reactions attributable to allergy were noted 48 hours after the challenge phase. In the control group (associated with the treatment dose of 80 %), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase. In the treated group (treatment dose of 40 %), no macroscopic cutaneous reactions attributable to allergy were noted after the challenge phase. In the control group (associated with the treatment dose of 40 %), no macroscopic cutaneous intolerance reactions were recorded after the challenge phase.
Under the conditions of this study, the test material does not have to be classified in category 1 as a skin sensitiser, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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