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Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:
16 Sep - 03 Oct 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (M.A.F.F.), notification 59NohSan N° 4200 (1985)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, St Germain-sur-L'Arbresle, France
- Weight at study initiation: 2.6–3.2 kg (females)
- Housing: rabbits were housed individually in plastic cages.
- Diet: certified pellet diet 112C (Usine d'Alimentation Rationnelle, Villemoisson-sur-Orge, France), ad libitum
- Water: filtered and softened water from the municipal water supply, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17–21
- Humidity (%): 40-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 Sep 1997 To: 03 Oct 1997
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: left flanks remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g (1 mL of 0.9% saline was used to moisten the test substance to ensure good contact with the skin)

Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the right flank
- Type of wrap: the test substance was covered by a hydrophilic gauze patch, which was secured by a semi-occlusive hypoallergenic dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the residual test substance was gently removed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test substance elicited no cutaneous reactions when applied to the rabbit skin.
Other effects:
No further local or systemic effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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:
16 Sep - 10 Oct 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (M.A.F.F.), notification 59 NohSan N° 4200 (1985).
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, St Germain-sur-L'Arbresle, France
- Housing: rabbits were housed individually in plastic cages.
- Diet: certified pellet diet 112C (Usine d'Alimentation Rationnelle, Villemoisson-sur-Orge, France), ad libitum
- Water: filtered and softened water from the municipal water supply, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17–21
- Humidity (%): 40-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 Oct 1997 To: 10 Oct 1997
Vehicle:
unchanged (no vehicle)
Controls:
other: right eye remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 0.5% sodium fluorescein solution and UV lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Test substance instillation into the rabbit eye induced no iridial, corneal and conjunctival changes.
Other effects:
No further local or systemic effects were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritating potential of the test substance was investigated in a study following OECD guideline 404 and in compliance with GLP (Thouvenin, 1997a). The unchanged test material (0.5 g) was prepared on a moistened patch and applied to the clipped skin of the right flank of 6 female rabbits for 4 h under semiocclusive conditions. The skin of the left flank remained untreated and served as control site. Skin reactions at the treated sites were evaluated 1, 24, 48 and 72 h after removal of the patches. Single application of the test substance elicited no irritation to the rabbit skin. No signs of systemic toxicity were seen. The mean erythema and oedema scores over 24, 48 and 72 h were 0 for all 6 animals.

 

Eye irritation

An eye irritation study was conducted with ethiprole according to OECD guideline 405 and under GLP conditions (Thouvenin, 1997b). The unchanged test material (0.1 g) was placed into the lower conjunctival sac of the left eye of 6 female rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Test substance instillation into the rabbit eye induced no iridial, corneal or conjunctival effects. No further local or systemic toxic effects were observed. The mean cornea, iris, conjunctivae and chemosis scores over 24, 48, and 72 h were 0 for all 6 animals.

 

Respiratory tract

This information is not available.

Justification for classification or non-classification

The available data on skin and eye irritation of ethiprole do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.