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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
Study period:
06 Mar 1992 - 02 Feb 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA was not yet validated at the time of the study.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation:
- Weight at study initiation: test group: 342.6 ± 19.63 g; vehicle controls: 342.3 ± 17.62 g
- Housing: 1 - 4 per cage, Makrolon Type IV
- Diet (e.g. ad libitum): Altromin tpf 3022, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Quarantine: 6 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 45 - 65%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 1992-08-04 To: 1992-09-24

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.2%
Day(s)/duration:
Day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1.0%
Day(s)/duration:
Day 7, 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.005%
Day(s)/duration:
Day 21, 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
22
Details on study design:
RANGE FINDING TESTS:
Intradermal: 0.2%, 1%, 5%, 10% w/w in paraffin oil
Topical: 0.005%, 0.01%, 0.05%, 0.2%, 1%, 4%, 10%, 25% w/w in petrolatum
Challenge controls:
22 naive (sham-induced) animals
Positive control substance(s):
yes
Remarks:
DNCB, 0.1% (ethanol), 1.0% (petrolatum), 0.025% (petrolatum) for intradermal induction, topical induction, and challenge, respectively.

Results and discussion

Positive control results:
22/22 of animals showed skin reactions

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.005%
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.025%
No. with + reactions:
22
Total no. in group:
22
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.025%
No. with + reactions:
22
Total no. in group:
22
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the GPMT results, DMPT is not a skin sensitizer.