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Diss Factsheets

Administrative data

Description of key information

Guinea pig (GPMT): not sensitizing, OECD Guideline, GLP (Safepharm Laboratories Ltd, 1253/006, 1998). Only an incomplete study report is available and relevant data are missing. The reliability of the study is therefore restricted. However, with 20 animals, no skin reactions were noted 24 and 48 hours after challenge.

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
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:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When this study was performed, the LLNA method did not yet exist in form of an OECD testing guideline.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 288 - 374g
- Housing: singly or in pairs
- Diet (ad libitum): Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K., ad libitum
- Water (ad libitum): mains tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 53-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal induction: 25% (w/v) dilution of test material in distilled water
Topical induction: 50% w/w in distilled water
Topical challenge: 50% and 25% w/w in distilled water
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal induction: 25% (w/v) dilution of test material in distilled water
Topical induction: 50% w/w in distilled water
Topical challenge: 50% and 25% w/w in distilled water
No. of animals per dose:
20 test animals, 10 control animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Induction
- The injections were:
• Test groups
Shortly before treatment on day 0 the hair was removed from an area of appr. 40 mm x 60 mm on the shoulder of each animal with veterinary clippers. A row of three injections (0.1 mL each) was made on each side of the mid-line:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 25% w/v formulation of the test material in distilled water
iii) a 25% w/v formulation of the teswt material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
• Control group:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) arachis oil B.P.
iii) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.

Epicutaneous Induction
- No. of exposures: 1, one week after intradermal induction
- Site: the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the test material formulation. A filter paper patch (40 mm x 20 mm), loaded with the test material formulation as a thick, even layer was applied to the prepared skin and held in place with a strip of surgical adhesive tape (50 mm x 30 mm) covered with an overlapping length of aluminium foil. The patch and foil were further secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
- Frequency of applications: once
- Duration: 48 hours
- Concentrations: 50% w/w in distilled water

B. CHALLENGE EXPOSURE
parts of the description were lacking
-Exposure period: 24 h
-Site: both flanks
-Concentrations: 25 and 50%
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.

- Skin Reactions observed after intradermal induction

The test material injection sites could not be evaluated due to orange-coloured staining. Incidents of very slight erythema were noted at the intradermal injection sites of control group animals at the 24 and 48-hour observations.

- Skin Reactions observed after topical induction

Orange-coloured staining was noted at the topical induction sites of all test group animals at the 1 and 24-hour observations. The staining prevented an evaluation of the degree of erythema at all of these sites except one, where very slight erythema was noted at the 24-hour observation.

Very slight oedema was also noted at the induction sites of eight test group animals at the 1-hour observation.

Incidents of bleeding were noted in test and control group animals at the l-hour observation.

No skin reactions were noted at the topical induction sites of control group animals at the 1 and 24-hour observations.

 

- Skin Reactions observed after topical challenge

Orange-coloured staining was noted at all challenge sites at the 24 and 48-hour observations.

No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guinea pig maximization test (Safepharm Laboratories Ltd, 1253/006, 1998), which was performed according to OECD guideline 406 and GLP requirements, young female Dunkin-Hartley guinea pigs (20 animals) were treated with the test substance, dissolved in distilled water. Intradermal injections were performed with 25% of the test substance and topical inductions were carried out with 50% one week after intradermal inductions. After the topical induction, a challenge was performed epicutaneously with 25 and 50% of the test substance (on the right and left flank of the animals) four 24 hours.Evaluation for sensitisation was performed 24 and 48 hours post termination of exposure: the test material produced a 0% (0/20) sensitisation rate. Only orange-coloured staining was noted at all challenge sites at the 24 and 48-hour observations.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

 Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. No local reactions were observed in the guinea pig maximization test (OECD 406). Based on the data, classification for sensitisation is not warranted under Regulation (EC) No.1272/2008.

No data are available to assess the respiratory sensitization potential of the test material.