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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:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with internationally recognised test guidelines
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: 41 - 43 weeks
- Weight at study initiation: 4.3 - 5.2 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: 2013-01-27 To: 2013-02-12
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:
14 days
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:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: n/a
Irritant / corrosive response data:
No erythema or oedema was recorded in all animals approximately 1 hour after treatment. Well defined erythema (score 2) was observed in all animals approximately 24, 48 and 72 hours after dosing. Animals showed slight erythema (score 1) at observation performed on Day 8 of the study. Recovery occurred in all animals at the end of the observation period (Day 15).

AVERAGE SCORE
- Erythema: 2.0
- Edema: 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

0/0/0

0/0/0

24 hours

2/2/2

0/0/0

48 hours

2/2/2

0/0/0

72 hours

2/2/2

0/0/0

7 days

1/1/1

0/0/0

14 days

0/0/0

0/0/0

Average 24, 48 and 72 hours

2.0

0.0

 

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No systemic effects were observed. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation 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. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
June 18-21, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with internationally recognised test guidelines
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 OPPTS 870.2400 (Acute Eye Irritation)
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: 10 - 12 weeks
- Weight at study initiation: 2.4 - 2.5 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: 2012-06-18 To: 2012-06-21
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 after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize scale, acording to test guideline

TOOL USED TO ASSESS SCORE: None
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0
Other effects:
Slight conjunctival redness observed in all 3 animals and slight discharge observed in 1 animal 1 hour after exposure. Recovery occurred within 24 hours.

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

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 minites

0/0/0

 0/0/0

 1/1/1

 0/0/0

24 hours

 0/0/0

 0/0/0

 0/0/0

 0/0/0

48 hours

 0/0/0

 0/0/0

 0/0/0

 0/0/0

72 hours

 0/0/0

 0/0/0

 0/0/0

 0/0/0

Average 24, 48, 72 hours

 0.0

 0.0

 0..0

 0.0

 

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute eye irritation has ben investigated in the rabbit using methods in accordance with OECD/EU test guidelines. No significant irritation was observed.
Executive summary:

Acute eye irritation has ben investigated in the rabbit using methods in accordance with OECD/EU test guidelines. No significant irritation was observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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 not sufficient for the substance to require classification as an eye irritant.

Justification for selection of skin irritation / corrosion endpoint:
Single study available for evaluation

Justification for selection of eye irritation endpoint:
Single study available for evaluation

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

Observed response in both a skin irritation study and an eye irritation study was not of sufficient severity or persistence to require classification aacoding to the criteria of EC Regulation No. 1272/2008.

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