Registration Dossier
Registration Dossier
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EC number: 203-561-1 | CAS number: 108-21-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study in a peer reviewed journal. Some doubt about which isomer tested.
Data source
Reference
- Reference Type:
- publication
- Title:
- Development and validation of an alternative dermal sensitisation test: The mouse ear swelling test.
- Author:
- Gad SC, Dunn BJ, Dobbs DW, Reilly C, Walsh RD
- Year:
- 1 986
- Bibliographic source:
- Tox Appl Pharmac 84, 93-114
Materials and methods
- Principles of method if other than guideline:
- Mouse ear swelling test. Substance topically applied to shave body of animal on one or more daily occasions. 4 days after induction, test solution applied to one ear of mouse and inert vehicle to other ear as control. Difference in thickness of ears measured after 24 hrs from challenge and used as an indication of delayed type contact hypersensitivity response. Control animals that had not received the induction exposure also concurrently 'challenged' to check for unexpected irritation response.
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Substance described as 'butyl acetate'. Assumed to be n-butyl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories or Harlan Sprague-Dawley.
- Age: 6-8 weeks
- Housing: 5 per wire bottomed stainless steel cage
- Diet ad libitum): Purina Lab rodent chow 5001
- Water ad libitum)
- Acclimation period: 1 week
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction exposure: 100%
Challenge exposure: 50%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction exposure: 100%
Challenge exposure: 50%
- No. of animals per dose:
- 10 test animals, 5 irritation control animals
- Details on study design:
- A. INDUCTION EXPOSURE
- two id injections of FCA totalling 50ul injected at test site.
- No. of exposures: 3 consecutive daily applications of 100ul of substance. Allowed to dry before animals returned to cages
- Site: shaved stomach area.
- Concentration: neat
B. CHALLENGE EXPOSURE
- Days after last induction exposure: 7
- No. of exposures: 1
- Exposure: single applications of 20ul of test substance to left ear of mouse. 20ul of vehicle control applied to right ear
- Site: left and right ears
- Concentrations: 50% (maximum that did not cause irritation.)
- Evaluation (hr after challenge): 24 and 48 hrs. Ear thickness measured using a spring loaded 'Oditest' guage (accurate to 10um) following light anaethetisation of animals. - Challenge controls:
- Right ears of test animals plus irritation controls
- Positive control substance(s):
- yes
- Remarks:
- cinammic aldehyde
Results and discussion
- Positive control results:
- Other positive controls showed 100% of animals sensitised: these included toluene diisocyanate, oxazolone and N,N-dimethyl-p-nitrosoaniline.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: all readings combined
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: all readings combined. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: all readings combined
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: all readings combined. . Hours after challenge: 24.0. Group: positive control. Dose level: 50 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a mouse ear swelling test, n-butyl acetate showed no evidence of sensitising potential.
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