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Diss Factsheets

Administrative data

Description of key information

GLP guideline study according to OECD 406

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
Study period:
1999-02-23 to 1999-05-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Adopted 17th July 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Suitable non-LLNA data was already available.
Specific details on test material used for the study:
- CAS No.: 51581-32-9
- Batch No.: TMFP 304
- Purity: at least 99 %
- Solubility in water: soluble
- Storage: In the refrigerator, in the dark
- Appearance: colorless liquid
- pH: 7.29
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 341 g to 454 g
- Housing: Makrolon cages type III with wire mesh lids, single caging
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 60
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 (v/v) in: physiological saline, 1 + 1 (v / v) blended with FCA (Freund's complete adjuvant)
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
test substance, 5 % (v / v) in physiological saline
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
FCA, 1 + 1 (v / v) blended with physiological saline
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 g per animal
Day(s)/duration:
48 h
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 mL of test substance
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 mL of deionised water
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
20 animals for the test substance group
10 animals for the control group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h
- Test groups: Group C (test substance)
- Control group: Group K3 (negative control)
- Site: 2 cm X 4 cm


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21- 22
- Exposure period: 24 h
- Test groups: Group C (test substance)
- Control group: Group K3 (negative control)
- Site: 2 cm X 2 cm
- Evaluation (hr after challenge): 24 and 48 h

OTHER: A preliminary test was carried out with 3 female guinea pigs, pretreated with FCA. 4 different concentrations of the test substance were administered intradermally and 7 days later 4 concentrations of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of exposure was 24 hours. The test substance was dissolved in corn oil for the intradermal injections and in acetone for the epicutaneous administration.
Test substance concentration for Intradermal exposure: 0.1, 1.0, 5.0 and 20.0 %
Test substance concentration for Epicutaneous exposure: 1, 10, 50 and 100 %
Challenge controls:
0.5 mL of test substance and 0.5 mL of deionised water were applied to each animal.
Positive control substance(s):
yes
Positive control results:
90% (9/10) of the animals had a positive skin reaction. The results prove the sensitivity of the strain of animals used and the reliability of the experimental technique.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 5% TS intradermal + 100% TS epicutaneous; Challenge: 50% TS (left flank); water (right flank)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 5% physiological saline (intradermal) + water (epicutaneous); Challenge: 100% TS (left flank); water (right flank)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 5% TS intradermal + 100% TS epicutaneous; Challenge: 50% TS (left flank); water (right flank)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 5% physiological saline (intradermal) + water (epicutaneous); Challenge: 100% TS (left flank); water (right flank)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: periodic checks with known sensitizers (HEXYL ClNNAMIC ALDEHYDE)
Hours after challenge:
48
Group:
positive control
Dose level:
intradermal induction: 0.5% in corn oil; epicutaneous induction: 50% in acetone; challenge: 10% in acetoneaceton
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Mortality: 2 animals died on Day 1 after the intradermal induction exposure, 2 animals on Day 8 and 5 animals on Day 9 after the epicutaneous induction exposure. The cause of death in each case was intestinal obstruction or shock after extensive inflammation of the bowels, considered to be test substance related.

Body weight: No significant differences in the mean body weights between the test substance group and the control group were observed

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, the test item is not considered to be skin sensitizing under the UN GHS Criteria.
Executive summary:

In a dermal sensitization study (OECD 406) with the test item, 20 young adult female guinea-pigs of the HsdPoc: DH strain were tested using the method of Magnusson and Kligman. Two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure were performed. Observations were performed 24 and 48 h after the challenge exposure. All test substance treated sites of all animals of the negative control group and of the test substance group were normal at any observation time. No animal of the test substance group was regarded as sensitised.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a dermal sensitization study according to OECD 406, 20 young adult female guinea-pigs were tested negative using the method of Magnusson and Kligman.