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Diss Factsheets

Administrative data

Description of key information

Skin irritation potential of the substance BMS 217947-01 was tested according to EU Test Method B4, Directive 92/69/EEC and OECD Guideline 404. 500 mg of the test substance were diluted in distilled water and applied semi-occlusively on 3 New Zealand White rabbits. The test material produced a primary irritation index of 0.0 (according to the Draize classification scheme) and no corrosive effects were noted. Therefore, it does not meet the cirteria for classification as irritant or corrosive according to the CLP Regulation.

Potential of the substance BMS 217947-01 for causing eye damage or irritation was tested according to EU Test Method B5, Directive 92/69/EEC and OECD Guideline 405. The test substance was applied to 3 New Zealand White rabbits. Mild, transient irritation was observed. Iridial inflammation in two treated eyes was observed at the one hour observation, but it was resolved by the 24 hour observation. Moderate to mild redness and mild chemosis of the conjunctivae were observed, but the effects were fully reversible in all cases within 7 days. No corneal alterations were observed. As a result, the substance is not classified for causing eye irritation or eye damage.

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:
2 December 1998 - 5 December 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, Method B4;OECD Guideline No.404
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
The test substance was moistened with distilled water.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
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: 0 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: 0 d; Max. value at end of observation period: 0 (related to all animals)
Other effects:
The test material produced a primary irritation index of 0.0 to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a primary irritation index of 0.0 to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol & risk phrase are required.
Executive summary:

Skin irritation potential of the substance BMS 217947-01 was tested according to EU Test Method B4, Directive 92/69/EEC and OECD Guideline 404. 500 mg of the test substance were diluted in distilled water and applied semi-occlusively on 3 New Zealand White rabbits. The test material produced a primary irritation index of 0.0 (according to the Draize classification scheme) and no corrosive effects were noted. Therefore, it does not meet the cirteria for classification as irritant or corrosive according to the CLP Regulation.

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:
10th Dec 1998 - 24th Dec 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, Method B5;OECD Guideline No.405
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
30 mg
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hour
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hour
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hour
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
A single application of the test material to the non-irrigated eye of three rabbits produced translucent iridial inflammation in two treated eyes at the one hour observation. These had resolved by the 24 hour observation.
Moderate to mild redness of the conjunctivae was apparent up to 72 hours in two rabbits which had resolved by 7 days. Moderate to mild chemosis of the conjunctivae was also
present but resolved in all rabbits by 7 days. No corneal alterations were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
Mild, transient irritation may be possible but severity is not sufficient for classification under EC criteria.
Executive summary:

Potential of the substance BMS 217947-01 for causing eye damage or irritation was tested according to EU Test Method B5, Directive 92/69/EEC and OECD Guideline 405. The test substance was applied to 3 New Zealand White rabbits. Mild, transient irritation was observed. Iridial inflammation in two treated eyes was observed at the one hour observation, but it was resolved by the 24 hour observation. Moderate to mild redness and mild chemosis of the conjunctivae were observed, but the effects were fully reversible in all cases within 7 days. No corneal alterations were observed. As a result, the substance is not classified for causing eye irritiaion or eye damage.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The test material produced a primary irritation index of 0.0 (according to the Draize classification scheme) and no corrosive effects were noted. Therefore, it does not meet the cirteria for classification as irritant or corrosive according to the CLP Regulation.

Mild, transient irritation was observed, bur it was not sufficient for classification according to CLP