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EC number: 257-765-0 | CAS number: 52234-82-9
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- - Principle of test:
study conducted according to Magnusson, B. and Kligman A.M.: The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J. Invest. iDermatol. 52, 268 - 276 (1969)
- Short description of test conditions: intradermal and percutaneous (occlusive coverage; 1 week after intradermal induction) applikation of the test substance (induction); 3 percutaneous challenges (2, 3 and 4 weeks after the percutaneous induction);
- Parameters analysed / observed: body weight (recorded before each applikation and at the end of the observation period); clinical signs (assessed daily); sensitisation rate - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not established yet by the time the study was conducted.
Test material
- Reference substance name:
- Pentaerythritol tris(3-aziridin-1-ylpropionate)
- EC Number:
- 260-568-2
- EC Name:
- Pentaerythritol tris(3-aziridin-1-ylpropionate)
- Cas Number:
- 57116-45-7
- Molecular formula:
- C20H33N3O7
- IUPAC Name:
- 3-[(3-aziridin-1-ylpropanoyl)oxy]-2-{[(3-aziridin-1-ylpropanoyl)oxy]methyl}-2-(hydroxymethyl)propyl 3-aziridin-1-ylpropanoate (non-preferred name)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- No. of test material: 82/355-1
- Purity: ca. 99.5 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark
- Stability under test conditions: guaranteed for at least the study period
- Stability of the test substance in the solvent/vehicle: Since the test substance was prepared immediately before the application, stability was not tested.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: diluted in aqua dest.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, 4923 Extertal 1
- Microbiological status of animals, when known: SPF-LAC
- Age at study initiation: not specified
- Weight at study initiation: 250 - 309 g
- Housing: 5 animals per cage
- Diet: Saniff GK 4 mm, ad libitum
- Water: tap water ad libitum; twice a week tap water + ascorbic acid (0.2 g/L)
- Acclimation period: not specified
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1 % in aqua dest. or Freunds Adjuvant/Aqua dest. (1:1)
- Day(s)/duration:
- reading after 24 h
- Adequacy of induction:
- other: a higher concentration (5 %) caused mortality in a dose range finding study
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- approx. 0.3 g test substance (10 % in aqua dest.); sucked up by filter paper strips
- Day(s)/duration:
- 48 h; reading ca. 48 h after application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- approx. 0.15 g test substance (5 % in aqua dest.); sucked up by filter paper strips
- Day(s)/duration:
- approx. 2 weeks after last induction; 24 h; readings ca. 24 after patch removal as well as 48 and 72 h after application
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- approx. 0.15 g test substance (5 % in aqua dest.); sucked up by filter paper strips
- Day(s)/duration:
- 24 h; readings ca. 24 after patch removal as well as 48 and 72 h after application
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- approx. 0.15 g test substance (5 % in aqua dest.); sucked up by filter paper strips
- Day(s)/duration:
- 24 h; readings ca. 24 after patch removal as well as 48 and 72 h after application
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (10 in control group)
- Details on study design:
- RANGE FINDING TESTS: In a preliminary experiment with percutaneous occlusive application of the test substance, a concentration of 10 % aqueous test substance caused minimal skin irritation, whereas a concentration of 5 % aqueous test substance was determined as the highest non-irritant concentration. The intradermal application of a 5 % aqueous test substance preparation resulted in mortality of 18/20 animals. The 2 survivors showed bad general conditions.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and percutaneous)
- Exposure period: 48 h (percutaneous induction)
- Control group: only for the intradermal injection; without test substance
- Site: shoulders (intradermal induction); flanks (percutaneous induction)
- Frequency of applications: 2 injections
- Duration: percutaneous induction was performed 1 week after the intradermal induction
- Concentrations: 1 % test substance in aqua dest. or Freunds Adjuvant/Aqua dest. (1:1) for the intradermal induction; approx. 0.3 g test substance (10 % in aqua dest.), sucked up by filter paper strips for the percutaneous induction
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: 1st challenge approx. 2 weeks after the last induction; 2nd challenge 1 week later; 3rd challenge 2 weeks after the 1st challenge
- Exposure period: 48 h each
- Control group: same procedure as for the experimental groups
- Site: flanks
- Concentrations: approx. 0.15 g test substance (5 % in aqua dest.), sucked up by filter paper strips
- Evaluation (hr after challenge): ca. 24, 48 and 72 h after application - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st challenge
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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