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Description of key information

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:
2012
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
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 2.8 - 2.9 kg
- Housing: single housing in polycarbonate/stainless steel cages
- Diet (e.g. ad libitum): Stanrab (P) SQC from Special Diet Services available ad libitum
- Water (e.g. ad libitum): Municipal supply available ad libitum
- Acclimation period: at least 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2012-09-16 To: 2012-09-21
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted (as supplied)

VEHICLE
- Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm area of skin clipped free of hair on the dorsal and lateral parts of the trunk of the animals
- % coverage: Not applicable to test method
- Type of wrap if used: Surgical gauze tape 25 x 25 mm (soaked with test substance) held in place by non-irritating tape. The application area was then immobilised with an elastic adhesive dressing acting as a semi-occlusive barrier

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scale according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritant / corrosive response data:
Very slight erythema was recorded in 2 of the 3 animals approximately 1 hour after treatment. Recovery had occurred within 24 hours and no response to treatment was evident.

AVERAGE SCORE
- Erythema: 0.0
- Oedema: 0.0
Other effects:
There was no indication of a systemic effect

Irritant/corrosive response data for each animal at each observation time of each animal from the test

Time point

Erythema

Oedema

Max. score: 4

Max. score: 4

60 minutes

1/1/0

0/0/0

24 hours

0/0/0

0/0/0

48 hours

0/0/0

0/0/0

72 hours

0/0/0

0/0/0

Average 24, 48 and 72 hours

0.0

0.0

 

Interpretation of results:
GHS criteria not met
Conclusions:
No systemic effects were observed. Very slight erythema was observed following treatment which had resolved within 24 hours. The observed irritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.
Executive summary:

Dermal irritation following a 4 hour exposure period has been assessed in accordance with OECD/EU test methods.

No systemic effects were observed. Very slight erythema was observed following treatment which had resolved within 24 hours. The observed irritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.

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:
2012
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
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: 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 Italia S.p.A.
- Age at study initiation: 15 - 17 weeks
- Weight at study initiation: 2.9 kg
- Housing: conventional, singly housed in metal cages with perforated noryl floors
- Diet (e.g. ad libitum): Stanrab (P) from Special Diet Services UK, ad libitum
- Water (e.g. ad libitum): Municipal supply ad libitum
- Acclimation period: at least 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2012-10-15 To: 2012-11-05
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, 7, 14 and 21 days after application
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize scale, according to test guideline

TOOL USED TO ASSESS SCORE: None
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Response was assessed in a single animal. Well defined conjunctival chemosis and moderate redness were observed 1, 24 and 48 hours post-exposure. Seventy-two hours after exposure, slight chemosis and severe redness were observed. Slight redness was still observed after 7 and 14 days. Slight discharge and chemosis were noted after 14 days after dosing. Slight corneal opacity with the area of cornea involved greater than half was observed from 1 hour post-exposure up to the end of the observation period (21 days after treatment). The extension of the opacity gradually decreased from 48 hour post-exposure.

AVERAGE SCORE
- Cornea: 1.0
- Iris: 0.0
- Conjuntivae (Redness): 2.3
- Conjuntivae (Chemosis): 1.7

Irritant/corrosive response data at each observation time

 


Score at time point / Reversibility

Cornea

Iris

Conjunctival redness

Conjunctival chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 minutes

1

0

2

2

24 hours

 1

 0

2

 2

48 hours

 1

 0

 2

 2

72 hours

 1

 0

 3

 1

7 days

 1

 0

 1

 0

14 days

 1

 0

 1

 1

21 days

 1

 0

 0

 0

 

Average 24, 48, 72 hours

 

1.0

 

0.0

 

2.3

 

1.7

 

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Acute eye irritation has been investigated in the rabbit using methods in accordance with OECD/EU test guidelines. Significant irritation was observed that had not resolved within 21 days.
Executive summary:

Acute eye irritation has been investigated in the rabbit using methods in accordance with OECD/EU test guidelines. Significant irritation was observed that had not resolved within 21 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute dermal irritation has been assessed in the rabbit using OECD/EU test methods. The irritation observed was not of sufficient severity or persistence for the substance to require classification as a skin irritant.

Acute eye irritation has been assessed in the rabbit using OECD/EU test methods. The severity and persistence of ocular response was sufficient for the substance to require classification as an eye irritant.

Justification for classification or non-classification

Skin:

Based on the results of the available data the substance does not require to be classified and labelled according to Regulation 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).

Eyes:

The information available is regarded as sufficient to be able to draw conclusions regarding the need for classification. Classification as serious eye damage Category 1 - H318 according to CLP (1272/2008/EC) and risk of serious damage to eyes - R41 according to 67/548/EEC is indicated.

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