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Administrative data

Description of key information

A skin irritation test showed no edema and no histological changes.

An eye irritation test showed no effects on the eyes.

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:
1972
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drogs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the United States of America.
Version / remarks:
1965
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- mean weight at study initiation: males 2.90 kg, females 2.73 kg
- Housing: Rabbits were caged singly in a room.
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum and sterile filtered water was available at all times.
- Acclimation period: six rabbits were maintained under pretest conditions for one week prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to fifteen hours of artificial light from 8.00 hours to 23.00 hours daily.
Type of coverage:
occlusive
Preparation of test site:
other: abraded and shaved
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application side: back
- % coverage: at least 10% of the total body surface
- Type of wrap if used: aluminium foil secured with "sleek" adhesive tape, which was in turn covered by Coban 6 wide self-adhering elastic bandages
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
0.09
Max. score:
4
Reversibility:
fully reversible
Remarks:
after 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritant / corrosive response data:
Due to the staining of the stratum corneum by the test compound, it was impossible to assess the degree of erythema.

Histopathological report on Biopsy Specimens:

One animal No. 15 revealed a minimal acanthosis of the epidermis. This lesion is of little significance and is such as might be caused by clipping and cleaning the area of skin involved.

Interpretation of results:
GHS criteria not met
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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to
Guideline:
other: Regulation under the Federal Hazardous Substance Labelling Act (February 1965) Part 191.12(b)(2)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- mean body weight at study initiation: males 2.90 kg and females 2.73 kg
- Housing: 6 rabbits were maintained under pretest conditions for one week prior to to the test.
- Diet: a commercial irradiated diet /Styles-Oxoid) was fed ad libitum
- Water: water was available at all times.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 - 70%
- Photoperiod (hrs dark / hrs light): animals were exposed to fifteen hours of artificial light from 08.00 hours to 23.00 hours daily.

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 25 mg (= 0.1 mL bulk volume)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
6
Details on study design:
- the test substance was applied into the conjunctival sac of the left eye. The eyelids were then closed for one second.
- the non-treated left eye served as control
- the test substance was not washed out
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
3

Clinical Symptoms:

1 hour: Very mild ptosis present in one animal (male)

2. hours. Very mild ptosis present in one male and one female

4 hours: All animals normal and remained normal until autopsy

The nature of the material precluded any further detailed assessment at the times other than the examination of the lids and evidence of chemosis.

Autopsy:

No lesions attributed to the compound were found

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An acute skin irritation study with New Zealand White rabbits was performed (Ciba-Geigy, 1972) according to the method in the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" published by the Editorial Committee of the Association of Food and Drug Officials of the united States of America (1965). Twenty-four hours prior the dermal application, the backs of the rabbits were shaved over an area constituting at least 10% of the total body surface. On each rabbit two test sites located at the mid-line of the back, were used. Immediately before application the right hand site was abraded, the left hand site remained intact. 500 mg of the test substance was mixed with 0.5 mL 66 OP Industrial Spirit and applied to each test site on a gauze pad approximately 2.5 x 2.5 cm. The test sites were covered with an occlusive dressing for 24 hours. Due to substance-colored skin, it was impossible to assess the degree of erythema. The test substance did not cause any irritation on the intact skin of the test animals (mean edema score (24, 72 h) of 0 and no histological signs of an effect). One animal with abraded skin developed very slight edema at 24 hours. A mean edema score (24, 72 h) of 0.09 awas observed on the abraded skin. The observed edema effect was fully reversible within 72 hours. Because of the findings regarding the intact skin, the test substance is not considered irritating to the skin.

An acute eye irritation study with New Zealand White rabbits was performed (Ciba-Geigy, 1972) according to the procedure set out in the Regulations under the Federal Hazardous Substances Labelling Act (February 1965) Part 191.12. 25 mg of the test material, equivalent to 0.1 mL volume was instilled into the conjunctival sac of the left eye of 6 Vienna White rabbits. The eyelids were then closed for one second and the test substance was not washed out. The eyes were examined at the following times after application of the test substance: 1, 2, 4, 24, 48 and 72 hours. At no time an irritation of the eye was observed (mean score of six animals (24,48,72 h) = 0). Based on the results of this study, the test substance is not considered irritating to the eye.

Justification for classification or non-classification

Based on the available information classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.