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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:
other: conforms to current guideline and GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This Guinea pig maximization test was performed in 2001, i.e. before the LLNA became the standard test for assessment.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): TPP
- Physical state: White granular solid
- Lot/batch No.: F21022
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: supplied by David Hall Limited UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 345 - 410 g
- Housing: singly or in pairs in solid floor polyproylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to guinea pig FD1 diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 deg C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours/light


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
intradermal induction: 5%
topical induction: 75 %
topical challenge: 75 % and 50 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
intradermal induction: 5%
topical induction: 75 %
topical challenge: 75 % and 50 %
No. of animals per dose:
10 test and 5 control
Details on study design:
1st application; intradermal induction:
Shortly before treatment the hair was removed from an area approx. 40 x 60 mm on the sholder region of each animal. A row of three injections was made:
a) Freud's Complete Adjuvant plus destilled water in a ration 1:1
b) 5 % w/w TPP in arachis oil
c) a 5% w/w formulation of TPP in a 1:1 preparation with Freud's Complete Adjuvant plus destiled water
Approx. 24 and 48 hours after intradermal induction the degree of erythema at the test material injection site was evaluated.

2nd application; topical induction:
On day 7 the same area was clipped again and treated with topical application of the test material (75 % w/w in arachis oil; occlusive epicutaneous)

3rd application topical Challenge:
On day 21 an area of approx. 50 x 70 mm on both flancs of each animal was ciplled free of hair and topicallytreated with 75 % and 50% w/w TPP in arachis oil (occlusive epicutaneous)
Positive control substance(s):
yes
Remarks:
2-Mercaptobenothiazole

Study design: in vivo (LLNA)

Positive control substance(s):
mercaptobenzothiazole (CAS No 149-30-4)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 and 75 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 and 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 and 75 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 and 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not sensitizing
Executive summary:

A study was performed to assess the contact sensitisation potential of TPP in guinea pigs according to OECD guidelines study 406. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on sighting tests, the concentrations of TPP for the induction and challenge phases were selected as:

Intradermal induction: 5%w/w in arachis oil; Topical Induction: 75%w/w in arachis oil; Topical challenge 75 and 50%w/w in arachis oil. The results showed that TPP produced a 0% (0/10) sensisitisation rate and classified as a non-sensitiser to guinea pig skin.