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Administrative data

Description of key information

No skin irritation potential as well as no eye irritation potential was determined in two skin irritation studies and in two eye irritation studies with the test substance and the read-across test substance (free acid of Diflufenzopyr sodium salt).  

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:
1995-05-23 until 1995-05-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically reliable study, similar to current OECD guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
November, 1984
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2.1 to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°c
- Humidity: 30 - 70 %
- Air changes: 19 air changes per hour
- Photoperiod: 12 hours of artificial light

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: moistened with 0.5 ml distilled water
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours after test substance application
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 100 mm X 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing on the moistened gauze pads

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean scores of animals 1-6
Time point:
other: 24, 48, 72 hours
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean scores of animals 1-6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
1995-05-30 until 1995-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically reliable study, similar to current OECD guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: a standard laboratory diet SDS Stanrab (P) Rabbit, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70 %
- Air changes: approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated as a control
Amount / concentration applied:
50 mg of the test substance
Duration of treatment / exposure:
Until end of the observation period
Observation period (in vivo):
1, 2, 3, 24, 48, 72 hours and 4 and 7 days after instillation
Number of animals or in vitro replicates:
7 rabbits
Details on study design:
SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0.05
Max. score:
4
Reversibility:
fully reversible within: 48 hours

One animal was not considered in the results/scores presented above (results of 6 animals presented instead of 7) as the animal was not treated as the rest of the animals (pre test). The treated eye of this animal was washed, in opposite to the other treated eyes of the other animals. No irritation/ corrosion effects were observed in the washed eye of this animal.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

Key study

A study was performed to assess the skin irritation potential of a formulation of the test substance to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81-5. Six rabbits were administered a single dermal dose of 0.5 g in a semi-occlusive application and observed for four days. Very slight dermal irritation was observed. The reactions had resolved by day 2 or 3.

Supporting study

A study was performed to assess the skin irritation potential of read-across test substance (free acid of Diflufenzopyr sodium salt) to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81-5. Six rabbits were administered a single dermal dose of 0.5 g in a semi-occlusive application and observed for four days. No dermal reactions occured.

Eye

Key study

A study was performed to assess the eye irritation potential of a formulation of the test substance to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81- 4. Seven rabbits were each administered a single ocular dose of 0.5 g of the test substance and observed for seven days after instillation. A transient mild to well-defined conjunctival irritation was observed. All reactions had resolved 1 or 2 days after instillation.

Supporting study

A study was performed to assess the eye irritation potential of the read-across test substance (free acid of Diflufenzopyr sodium salt) to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81- 4. Seven rabbits were each administered a single ocular dose of 0.3 g of the test substance and observed for seven days after instillation. Dulling of the cornea and mild conjunctival irritation were observed. All reactions had resolved 1 or 2 days after instillation.

Justification for selection of skin irritation / corrosion endpoint:
Most reliable study

Justification for selection of eye irritation endpoint:
Most reliable study

Justification for classification or non-classification

Based on data available the test substance is not classified for skin and eye irritation according to the criteria of Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).