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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published article fulfilled basic scientific principles.
Qualifier:
equivalent or similar to
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
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.
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;
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)
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
In a specific investigation on skin contact allergenic potential of homosalate equivalent to an OECD 406 study, homosalate was found not to be sensitizing.

Justification for selection of skin sensitisation endpoint:
Valid published literature investigating specifically the skin contact allergenic potential of the reference substance under use conditions (with and without UV exposure) as homosalate is used in sunscreen as UV filter.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Homosalate is not considered to be sensitizing.

Justification for classification or non-classification

The substance does not require classification for skin sensitization according to CLP (Regulation (EC) No 1272/2008) as it did not induce skin contact response when tested in accordance with OECD 406 (Guinea pig maximisation test). For respiratory irritation there is no valid test system available and no information was found in public literature correlating homosalate with concerns on respiratory sensitization. Therefore, homosalate is not classified for respiratory sensitization due to lack of data.