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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published article fulfilled basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Using UV generater to find the photoallergy of the test substance
Principles of method if other than guideline:
The literature does not give information for whether it was conducted with any standard or guideline, but comparing the method used in the report with OECD 406, it can be concluded the test procedure is similar to OECD test guideline 406.
GLP compliance:
no
Remarks:
Old publication
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Sensitization endpoint information was published in 1989, when GMPT test was still state of the art. To avoid additional animal testing LLNA was not performed.

Test material

Constituent 1
Chemical structure
Reference substance name:
Homosalate
EC Number:
204-260-8
EC Name:
Homosalate
Cas Number:
118-56-9
Molecular formula:
C16H22O3
IUPAC Name:
3,3,5-trimethylcyclohexyl salicylate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Hartley outbred guinea pigs, weighing 350 to 450 gm were used for the study. Groups were composed of equal numbers of males and females.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Ethanol
Concentration / amount:
Induction conditions; 1 % w/v in methanol or methanol alone; Challenge conditions 1 % w/v in acetone or acetone alone;
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Ethanol
Concentration / amount:
Induction conditions; 1 % w/v in methanol or methanol alone; Challenge conditions 1 % w/v in acetone or acetone alone;
No. of animals per dose:
20 animals per test group for induction with homosalate and UVA, 5 animal per test group for induction with sham and 10 animals per test group for induction with methanol and UVA
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Exposure period: 2 hours everytime
- Control group: yes
- Site: nuchal area
- Frequency of applications: 3 times per week
- Duration: 2 weeks
- Concentrations: HMS was applied as a 1 % (w/v) concentration in methanol for induction.

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 10 to 14 day
- Exposure period: 2 hours
- Control group: yes
- Site: dorsal area
- Concentrations: 1 % (w/v) concentration in acetone for challenge; The animals were then exposed to 10 J/cm2 UVA radiation.
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
vehicle control of acetone was used.
Positive control substance(s):
yes
Remarks:
musk ambrette (MA) and tetrachlorosalicylanilide (TCSA)

Results and discussion

Positive control results:
The results show that guinea pigs treated with MA + 10 J/cm2 UVA for both induction and challenge demonstrated incidence and severity indexes of 12/20 and 1.1, respectively. The data clearly indicate a classic photo-allergic response.

Guinea pigs treated with TCSA plus UVA at induction and challenge demonstrated approximately a 2-fold increase in both the incidence and severity response

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction with HMS+UVA; Test group challenge with UVA and 1% HMS in acetone
Dose level:
1% in acetone
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction with HMS+UVA; Test group challenge with UVA and 1% HMS in acetone. Dose level: 1% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction with HMS+UVA; Test group challenge with UVA and 1% HMS in acetone
Dose level:
1% in acetone
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction with HMS+UVA; Test group challenge with UVA and 1% HMS in acetone. Dose level: 1% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Sham induction; challenged by HMS + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Sham induction; challenged by HMS + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Sham induction; challenged by HMS + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Sham induction; challenged by HMS + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Sham induction; challenged by HMS only
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Sham induction; challenged by HMS only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Sham induction; challenged by HMS only
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Sham induction; challenged by HMS only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Sham induction; challenged by Acetone + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Sham induction; challenged by Acetone + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Sham induction; challenged by acetone + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Sham induction; challenged by acetone + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Sham induction; challenged by Acetone only
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Sham induction; challenged by Acetone only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Sham induction; challenged by acetone only
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Sham induction; challenged by acetone only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: induced by methanol + UVA; challenged by Acetone + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: induced by methanol + UVA; challenged by Acetone + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: induced by methanol + UVA; challenged by Acetone + UVA
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: induced by methanol + UVA; challenged by Acetone + UVA. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: induced by methanol + UVA; challenged by Acetone only
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: induced by methanol + UVA; challenged by Acetone only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
other: induced by methanol + UVA; challenged by Acetone only
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induced by methanol + UVA; challenged by Acetone only. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induced by HMS+UVA; challenged byHMS only
Dose level:
1% in acetone
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induced by HMS+UVA; challenged byHMS only. Dose level: 1% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induced by HMS+UVA; challenged byHMS only
Dose level:
1% in acetone
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induced by HMS+UVA; challenged byHMS only. Dose level: 1% in acetone. No with. + reactions: 0.0. 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:
It can be concluded the homosalate can not cause skin sensitisation both under and without UV radiation.
Executive summary:

The potential of homosalate and 2 known human photoallergens (musk ambrette and tetrachiorosalicylanilide) to cause photoallergy, and/or contact sensitization was determined using Guinea Pig Maximisation Test (GPMT), which was similar to OECD test guideline 406. The model was slightly modified by employing 6 exposures over 2 weeks and using Hill Top Chambers®for application of the test material. Musk ambrette and tetrachlorosalicylanilide (TCSA) was used as positive control in guinea pigs, although with TCSA. The results of studies conducted with homosalate showed that homosalate was neither allergen nor photoallergen.