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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The Maximisation test has been performed in 2006.

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.7%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-7 weeks
- Weight at study initiation: male 303-398 g; female 262-314 g
- Housing: 2 to 3 guinea pigs of same sex per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 64-66
- Air changes (per hr): min 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
5.0% v/v d-trans Allethrin in propylen glycol was selected for intrdermal injection.
Day(s)/duration:
day 0
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Undiluted d-trans Allethrin was selected for topical application during induction.
Day(s)/duration:
day 7
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Undiluted d-trans Allethrin was selected for topical application during challenge exposure.
Day(s)/duration:
day 21
No. of animals per dose:
30 guinea pigs.
Control: 10 animals (5 males and 5 females)
Treatment group: 20 animals (10 males and 10 females)
Details on study design:
The skin reactions were recorded post induction (intradermal injections/topical application) following the Draize method and at 24 and 48 hours post challenge treatment following the Magnusson and Kligman grading scale.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 ml
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:
test chemical
Dose level:
0.2 ml
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:
positive control
Dose level:
0.2 ml , 2 mercaptobenzothiazole
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2 ml , 2 mercaptobenzothiazole
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Very slight erythema (8/20 guinea pigs), well-defined erythema (12/20 guinea pigs) and very slight oedema (18/20 guinea pigs) to slight oedema (1/20 guinea pigs) on day 1 following intradermal injecton.

Very slight erythema (13/20 guinea pigs) well-defined erythema (7/20 guinea pigs) and very slight oedema (13/20 guinea pigs) on day 10 on the left flank of the treatment group guinea pigs following topical application on day 7.

No skin reactions in the guinea pigs from the control group either on day 1 or day 10.

Any positive skin response at 24 or 48 hours post patch removal.

No clinical signs.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A skin sensitisation rate of 0% at 24 and 48 hours post patch removal was observed using an adjuvant. d-trans Allethrin 75/25 is not considered as skin sensitiser to guinea pigs as the guinea pigs from the treatment group exhibited negative skin response.