Registration Dossier

Administrative data

Description of key information

No irritant effects were recorded on skin and eye of the rabbit

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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 2.0-2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: sesame oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50 % suspension

VEHICLE
- Amount(s) applied (volume or weight with unit): 500µL
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cellulose patch on a piece of surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water after exposure
- Time after start of exposure: 4 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4-72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
a transient, very slight erythema was recorded at the end of exposure only
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study test item is not irritating to skin.
Executive summary:

PROCEDURE

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g of the test item pasted with 0.5 ml sesame oil DAB 10.

The substance was administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage .

The exposure period was 4 hours.

After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE

All other changes of the skin were recorded.

RESULTS

30 - 60 minutes after decontamination two animals showed very slight erythema. 24 hours after decontamination all signs of irritation disappeared.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar all animals: 0.0

Oedema formation all animals: 0.0

Conclusion

Based on the results of this study 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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Age at study initiation:
- Weight at study initiation: 3.3-3.9 kg

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 ±20%

- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg/eye
Duration of treatment / exposure:
single instillation , rinsing after 24 h
Observation period (in vivo):
3 days (72 h)
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 0-72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0-72 h
Score:
0.55
Max. score:
1
Reversibility:
fully reversible within: 3 days
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Executive summary:

Procedure

100 mg of the test item were administered once to the conjunctival sac of the left eyes of three rabbits. The untreated eyes served in each case as a control. 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.

The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance. At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

RESULTS

One hour up to 48 hours after administration the conjunctivae of the animals showed definitely injected blood vessels and sporadically very slight swellings. Additionally, serous eye discharge was noted. Four days after administration all signs of irritating were reversible.

Opacity of cornea all animals 0.0

Iris all animals 0.0

Redness of conjunctiva all animals 0.55

Chemosis of conjunctiva all animals 0.0

Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.

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:
only valid available study

Justification for selection of eye irritation endpoint:
most recent and most valid study

Justification for classification or non-classification

No classification

No irritant effects were observed in studies for skin and eye irritation on rabbits.