sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate

Endpoint summary

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

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Version / remarks:

November, 1984

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

no

Qualifier:

equivalent or similar to guideline

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).