Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

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%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Jai Research Foundation
- Age at study initiation: 20 to 21 weeks
- Weight at study initiation: minimum 2.158 max 2.400 kg
- Housing: individual rabbit
- Diet:. ad libitum):
- Water : ad libitum
- Acclimation period: 5 to 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 64-65%
- Air changes (per hr): min 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.5 ml test item was aplied evenly to the clipped intact skin of rabbit.
Duration of treatment / exposure:
The treated and the control sites were covered with gauze patches secured at the margins by non-irritating tape for a period of four hours.
Observation period:
The skin reactions of all rabbits were observed and scored at 1, 24, 48 and 72 hours; at day 7 post patch removal (for rabbit 1) only
Number of animals:
3 healthy adult, male albino rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.33 - <= 1
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
At 24 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbits.
At 48 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbits no. 1 and 2 , and no erhytema and no oedema was observed on the treated site of the rabbits no.3.
At 72 h post patch removal, very slight erythema and no oedema was observed on the treated site of the rabbit no. 1 , and the treated site of rabbit no. 2 and 3 appeared normal.
At day 7 post patch removal the treated site of rabbit no. 1 appeared normal.
Other effects:
No clinical signs in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Since the mean scores of erythema and oedema following observation at 24,48,72 hours post patch removal were not significant in any of the tested rabbits, d-trans Allethrin was not classified as irritant for the skin.