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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
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
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
Induction exposure: 100%
Challenge exposure: 50%
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
Positive control results:
Other positive controls showed 100% of animals sensitised: these included toluene diisocyanate, oxazolone and N,N-dimethyl-p-nitrosoaniline.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
In a mouse ear swelling test, n-butyl acetate showed no evidence of sensitising potential.

Justification for selection of skin sensitisation endpoint:
only available reliable data

Justification for classification or non-classification