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Registration Dossier
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EC number: 907-498-7 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-06-09, 1992-07-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 84/449/EEC B.6 (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was not established at the time of study
Test material
- Reference substance name:
- Dioctadecyl 3,3'-thiodipropionate
- EC Number:
- 211-750-5
- EC Name:
- Dioctadecyl 3,3'-thiodipropionate
- Cas Number:
- 693-36-7
- Molecular formula:
- C42H82O4S
- IUPAC Name:
- dioctadecyl 3,3'-sulfanediyldipropanoate
- Details on test material:
- - Name of test material (as cited in study report): TK 10594 (IRGANOX PS 802)
- Substance type: Organic
- Physical state: Solid, white
- Analytical purity: >95 %
- Lot/batch No.: EN 255003.02
- Expiration date of the lot/batch: 1995-05
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, Stein, Switzerland
- Weight at study initiation: 318 - 430 g
- Housing: Individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): Ad libitum, standard guinea pig pellets (NAFAG No. 845, Gossau SG)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Arachis oil (first induction); vaseline (second induction and challenge)
- Concentration / amount:
- 5 % in arachis oil for intradermal injection
50 % (w/w) in vaseline for epicutaneous induction
30% in vaseline for challenge (highest non-irritant concentration)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Arachis oil (first induction); vaseline (second induction and challenge)
- Concentration / amount:
- 5 % in arachis oil for intradermal injection
50 % (w/w) in vaseline for epicutaneous induction
30% in vaseline for challenge (highest non-irritant concentration)
- No. of animals per dose:
- 10 males an 10 females in dose groups
5 males and 5 males in control group - Details on study design:
- RANGE FINDING TESTS: determination of the maximum subirritant concentration: 1, 5, 10, 30, and 50 % in vaseline. Erythema reactions were observed with 50 % TK 10594 in vaseline.
The highest dose for intradermal injection was chosen based on solubility and systemic tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (one intradermal and one epicutaneous)
- Exposure period: 48 h for epicutaneous induction
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant (FCA)/saline mixture 1:1 (v/v)
- test article in Oleum arachidis (w/v)
- test article in the adjuvant (FCA)/saline mixture (w/v)
In the second week of induction the test item was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
- Control group: FCA and vehicle
- Site: Neck
- Frequency of applications: Weekly
- Duration: 0-14 d
During weeks 3 and 4 no treatments were performed.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test item in vaseline or vaseline alone
- Control group: test item in vaseline or vaseline alone
- Site: Flank
- Concentrations: 30 %
- Evaluation (hr after challenge): 24 and 48 after removing the dressing - Challenge controls:
- No re-challenge performed.
- Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
- Positive control results:
- After 48 h challenge, 7 out of 10 animals were positive. After 72 hours 6 out of 10 animals were still positive .
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not sensitizing in the Guinea Pig Maximization test.
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