Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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%
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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.

Applicant's summary and conclusion

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.