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Administrative data

Description of key information

In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.

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:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
Four normal, healthy, albino rabbits, weighing 2 - 3.5 kg, were used in this study. The animals had been acclimated to laboratory conditions for at least two weeks prior to being placed on test. Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three cm, longitudinally, over the clipped area of exposure.
The test material, at a level of 5 ml. per kilo, was applied to the clipped intact and abraded skin areas. These areas were covered with a rubber sleeve or dam which fit snuggly around each animal. The animals were then placed in a multiple animal holder and held there for a twenty-four hour period. During this time each test animal was allowed its daily ration of rabbit pellets and water.
Following the twenty-four hour exposure period the rubber sleeves were removed from the test animals and skin reactions recorded. Each animal was thoroughly wiped down and returned to its own metabolism cage to be observed for a fourteen day period.
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
5 mL/kg
Duration of treatment / exposure:
24 h
Observation period:
up to 14 days
Number of animals:
4
Details on study design:
Single application of 5 mL/kg onto intact and abraded skin, occlusive dressing over 24 hrs, readings at patch removal
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
other: eschar score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.
Executive summary:

In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
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 vivo
Type of information:
experimental study
Adequacy of study:
key study
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
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: DR . K . THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: 3.00-3.38 kg
- Housing: single housing
- Diet (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Water (e.g. ad libitum): KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, (ABOUT 130 G PER ANIMAL PER DAY)
- Acclimatization period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: untreated eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1/24/48/72h and 8 d
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1/24/48/72h and 8d
Score:
0.2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 1/24/48/72 h and 8 d
Score:
2.1
Max. score:
3
Reversibility:
fully reversible
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Due reversible of conjunctivae redness (score >=2) a classification of Category 2B is justified.
Executive summary:

Three White New Zealand were subject to a single ocular application of 0.1 mL. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
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 conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.