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Toxicological information

Eye irritation

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Administrative data

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

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 405 (Acute Eye 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 / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.