Registration Dossier

Administrative data

Description of key information

Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.
Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.

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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
New Zealand albino rabbit
Charles River Deutschland GmbH
88353 Kißlegg
3 animals
3.4 - 3.6 kg b.w. at start of study
numbered ear tags for identification
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Polyethylenglycol 400 (0,5 mL)
Controls:
other: untreated skin
Amount / concentration applied:
500 mg per patch
Duration of treatment / exposure:
4 h
Observation period:
see details on study design
Number of animals:
3 animals
Details on study design:
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 Beta W 7 A 1.0 pasted with 0.5 ml
Polyethylenglycol 400 (Riedel de Haen Aktiengesellschaft). The substance was
administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of
surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). 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 (see Appendix "Scale for scoring dermal reactions", page 11). All
other changes of the skin were recorded.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin.
Other effects:
One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.
Executive summary:

Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance 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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand albino rabbit
Charles River Deutschland GmbH 88353 Kißlegg
3 animals
3.5 - 3.9 kg b.w. at start of study
numbered ear tags for identification
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
see details on study design
Observation period (in vivo):
see details on study design
Number of animals or in vitro replicates:
3 animals
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined
under UV light for comeallesions after instillation of one drop of a 0.01 %
fluorescein-sodium solution. Only animals without ocular abnormalities were used for
the study.
100 mg Beta W 7 A 1.0 was administered once to the conjunctival sac of the left eye
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 (see Appendix "Scale for scoring
ocular reactions" page 11 and 12). All other changes or toxic effects were recorded.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible within 2 days.
Other effects:
One hour up to one day after application the conjunctiva of the animals showed
definitely injected blood vessels up to more diffuse deeper crimson red colours and
slight swellings of lids. The irritations were attended by clear coloured eye discharge.
Two days p.a all irritations were reversible.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye.
Executive summary:

Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 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

Testing of Beta W 7 A 1.0 for primary eye irritation in the rabbit according to OECD 405 showed that the substance is not irritating to eye. Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.


Justification for selection of skin irritation / corrosion endpoint:
OECD Guideline Study

Justification for selection of eye irritation endpoint:
OECD Guideline Study

Justification for classification or non-classification