Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05/04/1997 - 17/03/1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP, Guideline study: Six rabbits instead of 3 (92/69/EEC B.4) were used since this is a regulatory requirement of EPA-FIFRA. The initial skin reactions were scored 30 minutes after patch removal rather than at 60 minutes. Clinical signs and body weights not reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
equivalent or similar 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)
Version / remarks:
(1982)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF 59 NohSan no. 4200 (1985)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand White (Hra:(NZW)SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 14-18 weeks old
- Weight at study initiation: 2260 – 2602 g
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
distilled
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 g
- pH: no data

VEHICLE
- Amount applied: 0.3 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 rabbits (5 males and female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: The occlusive dressings were removed and the test sites washed with water to remove all traces of test article.
- Time after start of exposure: After 4 hours

SCORING SYSTEM:
- Name of grading system: Dermal erythema & eschar formation and edema were graded according to the Draize scoring method and the primary dermal irritation index (PDII) was calculated. EPA and EU index scores were calculated for each animal.
- Time points where grading took place: 30 minutes after patch removal, and subsequently at 24, 48 and 72 hours.

STATISTICS:
No statistical methods were employed.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: overall
Score:
0.2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Three of the 6 test animals showed very slight (grade 1) erythema reactions 30 minutes after patch removal. Very slight erythema persisted in one of these animals until 24 hours, but was not apparent in the other 2 animals at this time. The remaining 3 animals showed no evidence of dermal irritation at any of the observation intervals. Edema and other manifestations of dermal irritation did not occur in any animal at any observation interval (Table 1). Five of the 6 animals had EU index scores of 0.0 and the remaining animal had an index score of 0.33. Consequently, dinotefuran is not classified as irritating to skin according to EU criteria. The PDII for dinotefuran was calculated as 0.2, a score defined as indicating slight irritation according to the EPA classification system.

Table 1: Individual skin irritation and index scores

Animal

Individual erythema / edema scores at:

EPA index

EU index

 

30 minutes

24 hours

48 hours

72 hours

score*

score**

1

1 / 0

0 / 0

0 / 0

0 / 0

0.25

0.0

2

0 / 0

0 / 0

0 / 0

0 / 0

0

0.0

3

0 / 0

0 / 0

0 / 0

0 / 0

0

0.0

4

1 / 0

0 / 0

0 / 0

0 / 0

0.25

0.0

5

0 / 0

0 / 0

0 / 0

0 / 0

0

0.0

6

1 / 0

1 / 0

0 / 0

0 / 0

0.50

0.33

Total score

(erythema + edema)

3

1

0

0

PDII***

0.2

Mean

0.06

* EPA index score = total erythema & edema score at all observation intervals / no. of observation intervals

** EU index score = total erythema & edema score at the 24, 48 and 72hr intervals / no. of observation intervals

*** PDII = sum of individual index scores / no. of animals, rounded to nearest 0.1

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dinotefuran does not require classification as a skin irritant in the EU according CLP regulation.
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
other justification
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05/04/1997 - 11/06/1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP, Guideline study: Nine rabbits instead of 3 (92/69/EEC B.5) were used, the eyes of 6 rabbits remaining unwashed (regulatory requirement in US) and the eyes of 3 animals washed 30 seconds after instillation of test article. Clinical signs and body weights (after treatment) not reported.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
equivalent or similar 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)
Version / remarks:
(1982)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF 59 NohSan no. 4200 (1985)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand White (Hra:(NZW)SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 14-18 weeks old
- Weight at study initiation: 2334 - 2694 g
- Sex: males and females
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
- Exposure period: Washed group: 3 rabbits 30-second exposure; Unwashed group: 6 rabbits 96 h
- Post-exposure period: 14-days
Observation period (in vivo):
- The treated eyes of all animals were examined for ocular irritation reactions 1, 24, 48, 72 and 96 hours and 7 and 14 days after instillation.
Number of animals or in vitro replicates:
9 rabbits, 6 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: With water (both eyes of 3 rabbits for 1 minute)
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Irritation reactions were graded and scored according to the Draize technique. Sodium fluorescein examinations were performed to assist the visualisation of possible corneal lesions

- pH: no data
- Statistics: no statistical analyses were employed
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 1 hour
Score:
13
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 24 hours
Score:
14.8
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 48 hours
Score:
6.7
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 72 hours
Score:
3.2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 96 hours
Score:
1.8
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 7 days
Score:
2.2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 14 days
Score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: unwashed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 1 hour
Score:
12
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 24 hours
Score:
14.7
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 48 hours
Score:
8.3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 72 hours
Score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 96 hours
Score:
3.3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 7 days
Score:
1.3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
overall irritation score
Remarks:
according to the method of Kay & Calandra (1962)
Basis:
mean
Remarks:
total eye irritation score at each interval for all animals / no. animals in the group
Time point:
other: 14 days
Score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: washed group
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
> 0 - < 2
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
> 0 - < 2
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 0 - < 3
Max. score:
2
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
> 0 - < 3
Max. score:
2
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
> 0 - < 3
Max. score:
2
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
> 0 - < 3
Max. score:
2
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
> 0 - < 3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
> 0 - < 2
Max. score:
2
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 0 - <= 1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
> 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 96 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
> 0 - <= 1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
> 0 - <= 1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
> 0 - <= 1
Reversibility:
fully reversible within: 96 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
> 0 - <= 3
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
The unwashed eyes of 4 of 6 animals showed slight (grade 1) corneal opacity with epithelial peeling, and iridial irritation in 2 of 6 animals within 24 hours of instillation of dinotefuran (Table 1 and Table 2). The reaction was accompanied by slight to moderate (grade 1 or 2) erythema, chemosis and clear or purulent discharge in all 6 animals. The eyes of 4 of the animals had returned to normal appearance within 96 hours of instillation and the remaining 2 animals had returned to normal 14 days after instillation. A positive reaction occurred in 3 of 3 animals in the washed group and was characterised by slight corneal opacity and slight to moderate erythema, chemosis and discharge. With the exception of one of 3 animals that showed slight erythema and chemosis on day 7, the washed eyes of all animals returned to normal appearance by 96 hours. The appearance of the eyes of the 3rd animal had returned to normal on day 14. The mean irritation scores for all ocular reactions according to Commission Directive 93/21/EEC (Annex VI) were greatest at 24 hours in both the washed and unwashed groups (Table 1). Thereafter, they progressively declined until day 14 at which time all animals in the washed and unwashed eye groups were free of all ocular irritation reactions. None of the individual animal or group mean irritation scores exceeded the EU criteria for classification as “irritating to eyes”.

Table 1: Group mean irritation scores according to Commission Directive 93/21/EEC (Annex VI)

Observation

Mean irritation scores in the:

 

Unwashed group at:

Washed group at:

 

1hr

24hr

48hr

72hr

96hr

1hr

24hr

48hr

72hr

96hr

Corneal opacity

0.2

0.7

0.2

0.2

0.2

0.0

1.0

0.0

0.0

0.0

Iris lesion

0.2

0.3

0.2

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Erythema

2.0

2.0

1.3

0.8

0.3

2.0

2.0

1.7

1.3

1.0

Edema

2.0

1.5

1.2

0.3

0.2

2.3

1.7

1.3

0.7

0.7

Table 2: Individual irritation scores

Observation

Time

Individual scores

 

 

unwashed group

washed group

 

 

1

2

3

4

5

6

7

8

9

Cornea

1hr

0 / 0

0 / 0

1 / 1

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

(severity/area)

24hr

0 / 0

0 / 0

1a/ 1

1a/ 1

1a/ 1

1a/ 2

1a/ 1

1a/ 1

1a/ 2

(A / B)

48hr

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

1a/ 1

0 / 0

0 / 0

1a/ 1

 

72hr

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

1a/ 1

0 / 0

0 / 0

0 / 0

 

96hr

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

1 / 1

0 / 0

0 / 0

0 / 0

 

7days

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

1 / 1

0 / 0

0 / 0

0 / 0

 

14days

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

Iris

1hr

0

0

1b

0

0

0

0

0

0

(C)

24hr

0

0

1b

0

0

1b

0

0

0

 

48hr

0

0

0

0

0

1b

0

0

0

 

72hr

0

0

0

0

0

0

0

0

0

 

96hr

0

0

0

0

0

0

0

0

0

 

7days

0

0

0

0

0

0

0

0

0

 

14days

0

0

0

0

0

0

0

0

0

Redness

1hr

2c

2c

2c

2c

2c

2c

2c

2c

2c

(D)

24hr

2c

2c

2c

2c

2c

2c

2c

2c

2c

 

48hr

1

1

1

1

2c

2c

2

1

2c

 

72hr

0

1

0

1

1

2

1

1

2c

 

96hr

0

0

0

1

0

1

1

0

2

 

7days

0

0

0

1

0

2

0

0

1

 

14days

0

0

0

0

0

0

0

0

0

Chemosis

1hr

2

2

2

2

2

2

2

2

3

(E)

24hr

1

2

1

1

1

3

2

1

2

 

48hr

1

1

1

1

1

2

1

1

2

 

72hr

0

0

0

0

1

1

0

0

2

 

96hr

0

0

0

0

0

1

0

0

2

 

7days

0

0

0

0

0

1

0

0

1

 

14days

0

0

0

0

0

0

0

0

0

Discharge

1hr

1d

1d

2d

2e

2e

2d

0

0

1e

(F)

24hr

0

1d

1d

1d

1d

2d

0

0

0

 

48hr

0

0

0

0

0

0

0

0

0

 

72hr

0

0

0

0

0

0

0

0

0

 

96hr

0

0

0

0

0

0

0

0

0

 

7days

0

0

0

0

0

0

0

0

0

 

14days

0

0

0

0

0

0

0

0

0

acorneal epithelial peeling;

binjected;

cblanching;

dclear discharge;

epurulent discharge

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dinotefuran is slightly irritating to the eyes of the rabbit but does not require classification in the EU according to the CLP regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

Justification for classification or non-classification