Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline confirmed study, no information about age and weight of study animals

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, Pennsylvania
- Age at study initiation: nn
- Weight at study initiation: nn
- Housing: Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 32-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 2.3.-3.4.2000

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
Injections for induction were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of 1.0% test material in PEG 400
c. Injection Pair C: 0.1 mL of 1.0% test material/FCA emulsion

Injections for the challenge and rechallenge control animals were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of PEG 400
c. Injection Pair C: 0.1 mL of 1.0% PEG 400/FCA emulsion

Topical Induction: 100 %, 0.25g

Challenge: 100 %, 0.25g
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
Injections for induction were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of 1.0% test material in PEG 400
c. Injection Pair C: 0.1 mL of 1.0% test material/FCA emulsion

Injections for the challenge and rechallenge control animals were as indicated below:
a. Injection Pair A: 0.1 mL of FCA emulsion
b. Injection Pair B: 0.1 mL of PEG 400
c. Injection Pair C: 0.1 mL of 1.0% PEG 400/FCA emulsion

Topical Induction: 100 %, 0.25g

Challenge: 100 %, 0.25g
No. of animals per dose:
10
Details on study design:
Dermal Observations
The test sites at challenge were graded for dermal irritation at approximately 24 and 48 hours following chamber removal using the Dermal Grading
System

Clinical Observations
Any unusual observations and mortality were recorded. The animals were observed for general health/mortality twice daily, once in the morning and once in the afternoon.

Body Weights
Individual body weights were obtained for all sensitization study animals on the day prior to intradermal induction (day -1) and for the test and challenge control animals on the day prior to challenge dosing. Final body weights were collected for all animals prior to euthanasia.

Scheduled Euthanasia
All sensitization study animals were euthanized by carbon dioxide inhalation following each animal's final scoring interval. Gross necropsy examinations were not required for these animals.
Challenge controls:
topical induction 0.8 ml PEG (solvent), challenge: 0.25g
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde

Results and discussion

Positive control results:
Using «-Hexylcinnamaldehyde as a positive control, Springbom Laboratories, Inc., Spencerville, Ohio, has completed a study during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Maximization Design). Following intradermal induction at 5.0% w/v alpha-Hexylcinnamaldehyde in propylene glycol, topical induction at 5.0% w/v alpha-Hexylcinnamaldehyde in propylene glycol and challenge at levels of 0.5% and 1.0% w/v «-Hexylcinnamaldehyde in propylene glycol, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the test substance is not considered to be a contact sensitizer in guinea pigs. The results of the alpha-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized by Springbom Laboratories would detect potential contact sensitizers.