Registration Dossier

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:
24 Feb - 05 Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: single housing
- Diet: Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay was provided three times per week.
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1-21.0 (actual temperature)
- Humidity (%): 39-61 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 cmx3 cm
- Type of wrap if used: metalline patch on micropore tape, wrapped around the abdomen and secured with coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean after 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight oedema (grade 1) were observed in all 3 animals 1 hour after exposure and were fully reversible within 24 h.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No staining of the treated skin by the test substance was observed and no test substance remnants were seen.

Table 1: Individual results of the skin irritation study.

Rabbit No.

1

2

3

Observation time

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

2

1

2

1

2

1

24 h

2

0

1

0

1

0

48 h

1

0

0

0

1

0

72 h

0

0

0

0

0

0

Mean value

1.0

0.0

0.3

0.0

0.7

0.0

24 + 48 + 72 h

Table 2: Age and body weight of the animals.

Rabbit No.

1

2

3

Age at start (weeks)

10-12

7-9

7-9

Body weight (gram)

 

 

 

prior to application

2484

1545

1771

at termination

2605

1650

1835

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:
01 Mar - 11 Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: single housing
- Diet: Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay was provided three times per week.
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-21.0 (actual temperature)
- Humidity (%): 37-66 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
(scoring after 1, 24, 48, and 72 h)
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
After the 24-h observation a solution of 2% fluorescein in water (pH 7) was instilled to both eyes of each animal to quantitatively determine corneal epithelial damage.

OBSERVATIONS:
Mortality/viability: checked twice daily
Toxicity: at least one daily
Body weight: day of treatment and at termination
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
After 1 h all 3 animals showed mild to moderate redness (score 1/2/2). At 24 h redness was reversed in 1 animal and the score of 2 was reduced to 1 in the other 2 animals. After 48 h no redness was observed in any animal.

Table 1: Individual results of eye irritation study.

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

2

 

 

 

 

1

2

0

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

3

 

 

 

 

1

1

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.67

0.00

0.00

0.00

24

0.67

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.22

0.00

0.00

0.00

Table 2: Age and body weight of individual animals.

Rabbit No.

1

2

3

Age at start (weeks)

11-13

10-12

10-12

Body weight (gram)

 

 

 

prior to application

2398

2575

2413

at termination

2541

2890

2610

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:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloropropenoic acid ester (CAS 96383-55-0) was tested for its skin irritation potential in a study according to OECD 404 in New Zealand White rabbits (van Otterdijk, 2004). The clipped skin of 3 animals was exposed to 0.5 g test material (undiluted) for 4 hours under semi-occlusive conditions. No edema reactions were observed 1, 24, 48, and 72 h after removal of the patch in any animal. At 24 h all 3 animals showed erythema reactions (score 2). At 24 h and 48 h erythema scores of 1/1/2 and 1/0/1 were observed in the animals. All erythema were fully reversed within 72 h. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. In conclusion, the test substance was not skin irritating under the experimental conditions of the study.

Eye irritation:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloropropenoic acid ester (CAS 96383-55-0) was tested for its eye irritation potential in a study according to OECD 405 in New Zealand White rabbits (van Otterdijk, 2004). The test substance (0.1 mL) was applied in one eye of 3 animals in a tiered approach (at first treatment of 1 animal, 7 days later treatment of 2 further animals). No washing was performed and the eyes were scored 1, 24, 48, and 72 h after instillation of the test substance. No effects on cornea and iris were observed in any animal at any reading time point. Slight redness (score 1-2) was observed 1 h after instillation in all 3 animals. In 1 animal the effects on the conjunctivae was fully reversible within 24 h. In the other 2 animals conjunctiva redness was observed at 24 h (score 1), but was fully reversible within 48 h. The mean values over 24, 48, and 72 h were 0 for cornea, iris and chemosis in all animals. For conjuctiva redness the mean values over 24, 48, and 72 h were 0.3 each in 2 animals and 0 in 1 animal. The effects were fully reversible within 48 h. In conclusion, the test substance was not irritating to the eyes under the experimantal conditions of the study.

 


Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Justification for classification or non-classification

The available data on skin- and eye irritation of 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloropropenoic acid ester 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.