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Description of key information

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Skin sensitisation

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Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
For animal welfare reasons no new study (LLNA) was conducted. Instead existing data was obtained via the SIEF. Therefore the type of study could not be influenced by the registrant at this point.
Species:
guinea pig
Strain:
other: Crl:(HA)BR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 416-485 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
1. induction: intradermal injection: 0.1%
2. induction: topical application: 5%
3. challenge: topical application: 1.0%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1. induction: intradermal injection: 0.1%
2. induction: topical application: 5%
3. challenge: topical application: 1.0%
No. of animals per dose:
20 for the test group
10 for the control group
Details on study design:
RANGE FINDING TESTS: In an irritation screening study, a subgroup of four male guinea pigs received 0.1mL intradermal injections of T-7 prepared at concentrations of 0.1, 1.0, 5, 10, and 25% w/v in sterile water (five test sites per animal). The test sites were evaluated for dermal reactions at 24 and 48 hours after injection. A second irritation screening subgroup of four animals first received duplicate 0.1mL intradermal injections of 1:1 Freund’s Complete Adjuvant (FCA) and sterile water on the shaved shoulder area (one injection on each side of the midline). Seven days after administration of the intradermal injections, the animals received a topical application of the test material at concentrations of 10, 25, 50 and 75% w/v in sterile water. Each animal received all four concentrations of the test material (four test sites per animal). All test sites were occluded for 24 hours. After treatment, all four animals exhibited severe dermal reactions at some of the sites and clinical signs of toxicity including hypoactivity, lacrimation, hypothermia, dyspnea, squinted eyes, and decreased feces. As a result of these observations, the animals were sacrificed in a moribund condition and 24 hour scores were not obtained. A third irritation screening subgroup of four animals first received duplicate 0.1mL intradermal injections of 1:1 Freund’s Complete Adjuvant (FCA) and sterile water on the shaved shoulder area (one injection on each side of the midline). Seven days after administration of the intradermal injections, the animals received a topical application of the test material at concentrations of 0.1, 0.5, 1.0 and 5.0% w/v in sterile water. Each animal received all four concentrations of the test material (four test sites per animal). All test sites were occluded for 24 hours and dermal irritation was evaluated at 24 and 48 hours after removal of the patches.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 inductions
- Exposure period: 1. intradermal injection 7 days, 2. topical application: 48 hours
- Test groups: 1 group received 1:1 dilution of FCA in sterile water or test substance diluted in water
- Control group: 1 group received 1:1 dilution of FCA in sterile water or water alone
- Site: intradermal injection: shoulder area: anterior sites, medial sites and posterior sites
- Frequency of applications: 3 intradermal injections, after seven days one topical application
Challenge controls:
Induction: intradermal injection: anterior site: 1:1 dilution of FCA in sterile water; medial site: sterile water; posterior site: 1:1 dilution of FCA in sterile water
Induction: topical application: sterile water
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
8
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 9.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
5
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 9.0.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on the results of this study the test item is not considered to be a dermal sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential of the substance was investigated in a Guinea Pig Maximization Test.

Based on the results of an irritation screening study the test item was administered as 0.1% (w/v) mixture in sterile water and in 1:1 FCA/sterile water for the intradermal injection phase, as a 5% (m/v) mixture in sterile water for the topical induction phase, and as a 1% mixture for the challenge application phase in the definitive study. Twenty animals were assigned to the test group and 10 animals were assigned to the irritation control group (negative control).

None of the animals in the test or the irritation control group exhibited a dermal reaction to the challenge application of the test material.

Therefore, based on the outcome of the available Guinea Pig Maximization Test, the substance is not considered to be a skin sensitizer.


Migrated from Short description of key information:
No sensitizing potential could be induced with the test substance in a Guinea Pig (modified) maximization test.

Justification for selection of skin sensitisation endpoint:
There is one valid GLP guideline study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
For the endpoint respiratory sensitization no study is available.

Justification for selection of respiratory sensitisation endpoint:
Data are conclusive but not sufficient for classification of the test substance with regard to skin sensitization in accordance to the CLP Regulation (EC) No 1272/2008.

Justification for classification or non-classification

Data are conclusive but not sufficient for classification of the test substance with regard to skin sensitization in accordance to the CLP Regulation (EC) No 1272/2008.