Registration Dossier
Registration Dossier
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EC number: 939-698-5 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 08 Mar - 08 Apr 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions. No positive controls were used to show the sensitivity and reliability of the assay.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive controls were used to show the sensitivity and reliability of the assay
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 110615-47-9
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- IUPAC Name:
- 110615-47-9
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: yellow viscous liquid
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Germany (preliminary study)
- Weight at study initiation: main study: 308.6 (controls) and 310.0 g (test groups); preliminary study: 334.7 g (group A), 312.7 g (group B) and 322.7 g (group C)
- Housing: animals were housed in groups of 5 (preliminary study) or groups of 2-3 (main study) in Makrolon Type IV cages.
- Diet: Altromin-Haltungsdiät 3032 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
- Concentration / amount:
- Induction, intradermal: 0.1%
Induction, epicutaneous: 10%
Challenge: 1.25 and 2.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
- Concentration / amount:
- Induction, intradermal: 0.1%
Induction, epicutaneous: 10%
Challenge: 1.25 and 2.5%
- No. of animals per dose:
- 20 (controls), 20 (test groups), 15 (preliminary study)
- Details on study design:
- RANGE FINDING TESTS:
A. Group A (5 animals) - Intradermal induction
- Test concentrations: 0.1, 0.5, 1.0 and 2.0%
- Results: 0.1% of the test substance was chosen for the main study, since it caused significant skin irritation and no necrosis.
B. Group B (5 animals) - Epicutaneous induction
Test concentrations: 5 and 10%
-Results: 10% of the test substance provoked slight skin irritation and eschar formation and was chosen as concentration for the main assay.
C. Group C (5 animals) - Challenge
Challenge: 2.5 and 5%
- Results: 2.5% of the test substance was selected for the main study, since 5% caused slight irritations in 4/5 animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA in 0.9% NaCl solution
Injection 2: test substance in 20% 1,2-propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: test substance in 1,2-propylene glycol
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA in 0.9% NaCl solution
Injection 2: 20% 1,2-propylene glycol
Injection 3: 20% 1,2-propylene glycol in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: 1,2-propylene glycol
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: twice (Day 1 and Day 8)
- Duration: Days 0-8
- Concentrations: intradermal 0.1%, epicutaneous 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance in 1,2-propylene glycol
- Control group: test substance in 1,2-propylene glycol
- Site: right flank (test substance)
- Concentrations: 1.25 and 2.5%
- Evaluation (hr after challenge): 24 and 48 h
- Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 1.25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 1.25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 2.5%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 2.5%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.1%; challenge: 1.25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.1%; challenge: 1.25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.1%; challenge: 2.5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.1%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 1.25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 1.25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 2.5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.1%; challenge: 1.25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.1%; challenge: 1.25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.1%; challenge: 2.5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.1%; challenge: 2.5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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