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Diss Factsheets

Administrative data

Description of key information

Skin irritation / corrosion: 
The individual mean scores (mean of 24, 48, 72 h) calculated for animals no. 1-3 were 0.33 / 0.00 / 0.66 for erythema and 0.33 / 0.00 / 0. 33 for edema. The effects were fully reversible within 72 h. No signs of skin corrosion were observed. Thus the test item did not induce significant or irreversible damage to the skin.
Eye irritation:
All individual mean scores (mean of 24, 48, 72 h) calculated for animals no. 1-3 were 0.00  for cornea, iris, conjunctivae chemosis and conjunctivae redness respectively. Slight initial effects at the 1 h reading were fully reversible within 24 h.  Thus the test item did not induce significant or irreversible damage to the eye.

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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP compliant OECD guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K.
- Age at study initiation: 12 - 17 weeks
- Weight at study initiation: 2.23 - 2.34 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers, Limited, New Leake, Boston, Lincolnshire, U.K.) ( ad libitum)
- Water: drinking water (ad libitum)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 60 - 65
- Air changes (per hr): PPROX: !%
- Photoperiod: 12 hrs dark /12 hrs light
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
the test material was moistened with distilled water
Controls:
no
Amount / concentration applied:
A quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (2 females, 1 male)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (gauze patch)
- Type of wrap if used: surgical adhesive tape (2.5 cm x 4 cm) additionally fixed with an elastic corset

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0; Very slight erythema (barely perceptible) 1; Well-defined erythema 2; Moderate to severe erythema 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema Formation
No oedema 0; Very slight oedema (barely perceptible) 1; Slight oedema (edges of area well-defined by definite raising) 2;
Moderate oedema (raised approximately 1 millimetre) 3; Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial signs of slight irritation were fully reversible within 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: no signs of irritation at any time
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites one hour after patch removal, at two treated skin sites at the 24-hour observation and at one treated skin site at the 48-hour observation.

Very slight oedema was noted at two treated skin sites at the 24-hour observation. No other adverse skin reactions were noted.

All treated skin sites appeared normal 72 hours after treatment.
Other effects:
No other effects reported.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test result, it is concluded thatthe test substance is not irritating to skin.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B.4. in Commission Directive 84/449/EEC.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. All treated skin sites appeared normal 72 hours after treatment. No corrosive effects were noted.

Based on these findings it is concluded that the test item is not irritating to skin.

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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP compliant OECD guideline study
Qualifier:
according to guideline
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: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.28 - 2.81 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers, Limited, New Leake, Boston, Lincolnshire, U.K. (ad libitum):
- Water: Drinking Water (ad libitum):
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 65 - 67
- Air changes (per hr): approximately 15
- Photoperiod: 12 hrs dark /12 hrs light
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye served as control
Amount / concentration applied:
0.1 ml of the test material, weighing approximately 64 mg
Duration of treatment / exposure:
single application without removal by washing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

- SCORING SYSTEM:
CONJUNCTIVAE Redness: 0 - 3; Chemosis: 0 - 4; Discharge: 0 - 3
IRIS: 0 - 2;
CORNEA Degree of Opacity: 0 - 4; Area of cornea involved: 0 - 4

- TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal: # 1-3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: no signs of irritation at any time
Irritation parameter:
iris score
Basis:
animal: # 1-3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 1-3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
animal: # 1-3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: initial signs of slight irritation - if any - were fully reversible within 24 h
Irritant / corrosive response data:
No adverse corneal effects were noted during the study.
Iridial inflammation was noted in two treated eyes one hour after treatment.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eyes appeared normal at the 24-hour observation.
Other effects:
No other effects reported.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test result, it is concluded that the test substance is not irritating to eyes.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC.

A single application of the test material to the non-irrigated eye of three rabbits produced slight iridial inflammation and minimal conjunctival irritation. All treated eyes appeared normal 24 hours after treatment.

Based on these findings it is concluded that the test item is not irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
no alternative study available

Justification for selection of eye irritation endpoint:
no alternative study available

Justification for classification or non-classification

The mean scores determined for skin irritation / corrosion and eye irritation are below the respective threshold values.

Since these findings do not meet the criteria for classification with respect to skin corrosion/irritation or serious eye damage/eye irritation according to the rules laid down in Directive 67/548EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.