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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 December 2009 - 12 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Fenitrothion TG
Reddish/yellow oily liquid
Lot No.: 070502
Purity: 95.1%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labs, Japan
- Age at study initiation: 11 weeks
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 5 January 2010 To: 8 January 2010

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
0.5 mL of the test material was applied to the clipped dorsal skin of three rabbits for 4 hours under semi-occlusive conditions. Exposure was terminated by washing the remaining test material from the application site with acetone. Local dermal reactions were scored at 24, 48 and 72 hours after removal of the dressing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no evidence of local dermal irritation at the application site in any rabbit at any time point.
Other effects:
There were no signs of toxicity.

Any other information on results incl. tables

Mean scores for irritation

 

24h

48h

72h

Mean (24-72h)

Erythema

0.00

0.00

0.00

0.00

Oedema

0.00

0.00

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There was no evidence of local dermal irritation at the application site in any rabbit at any time point; fenitrothion does not therefore require classification for skin corrosion or skin irritation according to the CLP criteria.
Executive summary:

The skin irritation potential of fenitrothion was investigated in a rabbit study according to OECD 404. 0.5 mL fenitrothion was applied to the clipped dorsal skin of three rabbits for 4 hours under semi-occlusive conditions.  Exposure was terminated by washing the remaining test material from the application site.  Local dermal reactions were scored at 24, 48 and 72 hours after removal of the dressing. There was no evidence of local dermal irritation at the application site in any rabbit at any time point; fenitrothion does not therefore require classification for skin corrosion or skin irritation according to the CLP criteria.