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Administrative data

Description of key information

Not irritating to the skin of rabbits (OECD TG 404, Schoch 1987)
Not irritating to the eyes of rabbits (OECD TG 405, Schoch 1987)

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:
27 January 1987 to 30 January 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2190 to 2320 g
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

IN-LIFE DATES: From: 27.01.1987 To: 30.01.1987
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: site moistened with distilled water containing 0.5% CMC and 0.1% polysorbate 80
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable

Duration of treatment / exposure:
4 hours
Observation period:
72 hours after removal of the treatment
Number of animals:
Three male rabbits
Details on study design:
TEST SITE
- Area of exposure: 36 cm2 of flank exposed, 0.5 g of test powder applied under small gauze
- Type of wrap if used: gauze patch covered by aluminium foil, secured around trunk by adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: not specified

SCORING SYSTEM: OECD Draize assessment method
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was evident for two rabbits at one and 24 hours. No other reactions were noted.
Other effects:
None
Interpretation of results:
not irritating
Conclusions:
The substance was not irritating to the skin of rabbits.
Executive summary:

The skin irritation properties of the substance were tested under GLP to OECD TG 404 in an in vivo study with rabbits. The solid test material was applied to a gauze patch moisturized with distilled water containing 0.5% carboxymethyl cellulose and 0.1% polysorbate 80 which was placed on the shaved flank of three male albino New Zealand White rabbits. Flanks were shaved 24 hours before dosing. 0.5 g of cloquintocet-mexyl applied to the skin on a gauze patch, was covered with aluminium foil and fastened around the trunk by an adhesive tape to form an occlusive dressing. The patch was held in place for 4 hours. Skin reactions were evaluated according to the OECD scoring system after 1, 24, 48 and 72 hours. Very slight erythema was reported at the one hour observation time in all three rabbits and at 24 hours in two rabbits. The erythema had fully reversed at 48 hours. No oedema or other dermal effects were observed. Cloquintocet-mexyl is non-irritating to the skin.

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:
24 December 1987 to 03 March 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2180 to 2550 g
- Housing: conventional laboratory housing units not otherwise specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

IN-LIFE DATES: From: 24.02.1987 To: 03.03.1987
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The report indicates 0.1 mL (a weight of 48 mg) was instilled into each treated eye
Duration of treatment / exposure:
The eyes were examined over a period of 7 days. No rinse out procedures were included to flush the test material away at any point
Observation period (in vivo):
Observation and assessment of ocular damage completed at 1, 24, 48 and 72 hours post-instillation and again after 7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Standard Draize method

TOOL USED TO ASSESS SCORE: None specified - simple visual checks only
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Signs of irritation were evident 1, 24 and 48 hours following instillation affecting the conjunctivae and cornea. No adverse effects noted for the iris.
All signs of irritation had resolved within 72 hours
Interpretation of results:
not irritating
Conclusions:
Cloquintocet-mexyl is not irritating to the eyes.
Executive summary:

An in vivo study in rabbits was conducted under GLP to OECD TG 405 to evaluate the eye irritation potential of the substance. An aliquot of 0.1 mL (48 mg) of cloquintocet-mexyl was placed into the conjunctival sac of one eye of three male New Zealand White rabbits. Ocular reactions were evaluated at 1, 24, 48, and 72 hours and 7 days following treatment. The results showed transient slightly irritating effects in the cornea and conjunctivae that had fully resolved within 72 hours. Cloquintocet-mexyl was evaluated to be not irritating to the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Cloquintocet-mexyl has been tested under GLP in rabbits to OECD TG 404 (Schoch M, 1987). An aliquot of 0.5 g of the solid test material was applied to a gauze patch moisturised with distilled water containing 0.5% carboxymethyl cellulose and 0.1% polysorbate 80. The gauze was placed on the shaved flank of three male albino New Zealand White rabbits. There was evidence of slight erythema after 1 and 24 hours which had fully reversed after 48 hours. No oedema or other adverse effects were observed. There was no evidence of corrosion.

Eye irritation

The substance has been tested under GLP in rabbits to OECD TG 405 (Schoch M, 1987). An aliquot of 0.1 mL (48 mg) of cloquintocet-mexyl was placed into the conjunctival sac of one eye of three male New Zealand White rabbits. Ocular reactions were evaluated at 1, 24, 48, and 72 hours and 7 days following treatment. The results showed transient slightly irritating effects in the cornea and conjunctivae that had fully resolved within 72 hours.

Justification for classification or non-classification

The substance does not meet the criteria for classification as skin or eye irritant
- under Regulation (EC) 1272/2008, Annex I, Part 3, 3.2.
- under Regulation (EC) 1272/2008, Annex I, Part 3, 3.3.