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Toxicological information

Skin sensitisation

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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: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The sensitization potential of some perfume ingredients tested using modified draize procedure
Author:
Sharp, DW
Year:
1978
Bibliographic source:
Toxicology, 9, 261-271

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
non-standard grading of skin effects, non-GLP
Principles of method if other than guideline:
The skin sensitisation potential of 3,5,5-trimethyl hexyl acetate was tested in guinea pigs in a modified Draize sensitisation test.
GLP compliance:
no
Type of study:
Draize test
Justification for non-LLNA method:
Study was performed before LLNA guideline implementation took place.

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexyl acetate
EC Number:
261-245-9
EC Name:
3,5,5-trimethylhexyl acetate
Cas Number:
58430-94-7
Molecular formula:
C11H22O2
IUPAC Name:
3,5,5-trimethylhexyl acetate
Details on test material:
3,5,5-Trimethylhexyl acetate, purity unknown

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Sensitization tests were carried out on inbred Hartley strain albino guinea pigs bred in our own colony. During testing they were housed in wire mesh
cages in pairs of the same sex and were fed pelleted guinea pig diet, cabbage, hay and water ad libitum. Ten animals weighing about 350 g at the start of testing were used in each test which comprised either 4 males and 6 females or visa versa. For demonstration of sensitivity by challenge with the test substance the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
Intradermal induction concentration: 0.5%
Intradermal challenge concentration: 0.2%
Epicutaneous challenge concentration: 20%
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
Intradermal induction concentration: 0.5%
Intradermal challenge concentration: 0.2%
Epicutaneous challenge concentration: 20%
No. of animals per dose:
10 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal injection at 4 sites
- Exposure period: 14 days
- Test groups: single test group of 10 animals
- Control group: none
- Site: 4 sites overlying the 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications: one
- Duration: 14 days
- Concentrations: 0.5% in 0.1 mL aliquots

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 14 days after induction
- Exposure period: One challenge as intradermal injection; for topical application not known, but test substance was probably not removed
- Test groups: single test group of 10 animals
- Control group: second challenge included control group
- Site: intradermal challenge in one flank and topical challenge in the other
- Concentrations: 0.2% in 0.1 mL aliquots intradermally; 20% in 0.1 mL aliquots topically
- Evaluation: first evaluation 24 hours after challenge; 7 days later second challenge with controls
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2% intradermally
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none were reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2% intradermally. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20% topically
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none were reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% topically . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
Reading:
rechallenge
Hours after challenge:
168
Group:
test chemical
Dose level:
0.2% intradermally
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none were reported
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: 0.2% intradermally . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
Reading:
rechallenge
Hours after challenge:
168
Group:
test chemical
Dose level:
20 % topically
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none were reported
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: 20 % topically. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU