Registration Dossier

Administrative data

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:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CGA185072 technical
- Physical state: solid
- Analytical purity: 91.6%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
>= 0.22
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Two rabbits had scores of 1 for erythema after 24 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
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

Any other information on results incl. tables

Table 1: Summary of results

Erythema and Eschar

Animal no.

1 M

2 M

3 M

after 1 hour

1

1

1

after 24 hours

1

0

1

after 48 hours

0

0

0

after 72 hours

0

0

0

mean score 24 to 72 h

0.22

Oedema

after 1 hour

0

0

0

after 24 hours

0

0

0

after 48 hours

0

0

0

after 72 hours

0

0

0

mean score 24 to 72 h

0

M: Male

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Very slight erythema was reported at the one and 24 hour observation times. No reactions were recorded at 48, and 72 hours. According to the Commission Directive 2001/59/EC the mean values of the scores between 24 to 72 hours after application were below the threshold for classification as an Irritant.
Executive summary:

Cloquintocet-mexyl technical, purity 91.6%, batch P. 607001/002. The solid test material was applied to a gauze patch moisturized with distilled water containing 0.5% CMC and 0.1% polysorbate 80 which was placed on the shaved flank of three male albino NZW 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. Cloquintocet-mexyl is non-irritating to the skin.