Registration Dossier

Administrative data

Description of key information

Guideline-compliant studies of skin corrosion/irritation and eye irritation in the rabbit are available for fenitrothion.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Fenitrothion TG
Reddish/yellow oily liquid
Lot No.: 070502
Purity: 95.1%
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
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.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Fenitrothion TG
Reddish/yellow oily liquid
Lot No.: 070502
Purity: 95.1%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kitayam Labs
- 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: 4 January 2010 To: 7 January 2010
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Not applicable: the treated eyes were unwashed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
0.1 mL of the test material was instilled into one eye of three rabbits. Ocular reactions were scored at 11, 24, 48 and 72 hours.
Irritation parameter:
cornea opacity 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:
cornea opacity 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:
cornea opacity 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:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis 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:
chemosis 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:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point. All reactions had resolved by 48 hours.

Summary of ocular reactions

 

24h

48h

72h

Mean (24-72h)

Cornea

0.00

0.00

0.00

0.00

Iris

0.00

0.00

0.00

0.00

Erythema

0.33

0.00

0.00

0.11

Chemosis

0.33

0.00

0.00

0.11

Interpretation of results:
GHS criteria not met
Conclusions:
Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point.  All reactions had resolved by 48 hours. The reactions are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.
Executive summary:

The eye irritation potential of fenitrothion was investigated in a rabbit study performed in compliance with OECD 405. 0.1 mL of the test material was instilled into one eye of three rabbits' ocular reactions were scored at 11, 24, 48 and 72 hours. Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point.  All reactions had resolved by 48 hours. The reactions seen in this study are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

The eye irritation potential of fenitrothion was investigated in a rabbit study performed in compliance with OECD 405. 0.1 mL of the test material was instilled into one eye of three rabbits' ocular reactions were scored at 11, 24, 48 and 72 hours. Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point.  All reactions had resolved by 48 hours. The reactions seen in this study are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.

There are no studies of respiratory irritation; however the lack of skin and eye irritation and the absence of relevant signs in the acute inhalation toxicity study indicate that fenitrothion is unlikely to be a respiratory irritant.

Justification for classification or non-classification

Fenitrothion has a harmonised classification under CLP and is not classified as a skin or eye irritant. The results of the available studies are consistent with the harmonised classification; no change is therefore proposed.