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Diss Factsheets

Administrative data

Description of key information

Guinea pig maximisation test: non-sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
This in vivo Guinea pig maximisation test was conducted before the amendments to the data requirements in Annex VII and VIII came into force.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Maximisation test according to Magnusson and Kligman (1970)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was conducted in 1988, before the LLNA method was established as the standard in vivo study for skin sensitisation
Species:
guinea pig
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 208-320 g
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
- Indication of any skin lesions: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
0.05 to 0.1 mL of a 3% w/v solution
Day(s)/duration:
Start of study
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
0.2 to 0.3 mL of a 30% w/v solution
Day(s)/duration:
One week after intradermal injection for 48 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
0.05 to 0.1 mL of a 10% and a 30% (w/v) solution
Day(s)/duration:
Two weeks after second induction for 24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
19 animals
Details on study design:
All animals were challenged two weeks after the topical induction by application of 0.05 to 0.1 mL of a 30% (w/v) solution of the test substance in corn oil to the left shorn flank and 0.05 to 0.1 mL of a 10% (w/v) solution of the test substance in corn oil to the right shorn flank for 24 hours, under occlusive dressings. The challenge sites were examined 24 and 48 hours after removal of the dressings and any erythema present were scored.
Challenge controls:
10 animals were treated in the same way as the 19 animals used in the study
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
1
Total no. in group:
19
Clinical observations:
None reported
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% w/v
No. with + reactions:
3
Total no. in group:
19
Clinical observations:
None reported
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
None reported
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30% w/v
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
None reported
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30% w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported

Following challenge with a 30% (w/v) solution of the test substance in corn oil, scattered mild redness was seen in three out of nineteen test animals. No response was seen in any of the control animals. The net percentage response was 16%. Therefore, challenge with the 30% (w/v) solution elicited a mild skin sensitisation response in previously induced guinea pigs.

Following challenge with a 10% (w/v) solution of the test substance in corn oil, scattered mild redness was seen in one of the nineteen test animals. No response was seen in any of the control animals. The net percentage response was 5%. Therefore, challenge with the 10% (w/v) solution elicited a weak skin sensitisation response in previously induced guinea pigs.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance did not elicit responses in this guinea pig maximisation test that would trigger a classification for skin sensitisation.
Executive summary:

The skin sensitisation potential of the test substance was investigated under non-GLP in a guinea pig maximisation test following the principles as described by Magnusson and Kligman (1970). The principles of the study are equivalent or similar to those laid down in the relevant OECD regulatory guideline. The experiment is considered relevant, adequate and conclusive.

The study involved two main procedures: an induction of a response and a challenge of that response. The induction was carried out upon 19 female guinea pigs, bodyweight range from 208-320 g. Firstly, intradermal injections of 0.05 to 0.1 mL of the following were made to the shorn scapular regions:

- Freund's Complete Adjuvant plus corn oil in the ratio 1:1,

- a 3% (w/v) solution of the test substance in corn oil,

- a 3% (w/v) solution of the test substance in a 1:1 mixture of Freund's Complete Adjuvant and corn oil.

Secondly, one week later a topical application of 0.2 to 0.3 mL of a 30% (w/v) solution in corn oil of the test substance was made to the shorn scapular region and was held in contact with the skin for 48 hours by means of occlusive dressings.

The nineteen test animals plus ten negative control animals were challenged two weeks after the topical induction by application of 0.05 to 0.1 mL of a 30% (w/v) solution of the test substance in corn oil to the left shorn flank and 0.05 to 0.1 mL of a 10% (w/v) solution of the test substance in corn oil to the right shorn flank for 24 hours, under occlusive dressings. The challenge sites were examined 24 and 48 hours after removal of the dressings and any erythema present were scored.

Following challenge with the 30% solution, scattered mild redness was seen in three out of 19 test animals. No responses were seen in any of the control animals. The net percentage response was 16%. Following challenge with a 10% solution, scattered mild redness was seen in one of the nineteen test animals. No response was seen in any of the control animals. The net percentage response was 5%.

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

The available in vivo guinea pig maximisation test is reliable, relevant and adequate for the derivation of a classification of the substance. Based on the results of the in vivo study, a classification for skin sensitisation under the CLP Regulation (EC) No. 1272/2008 is not warranted.