Registration Dossier

Administrative data

Description of key information

CSB caused in animals tests no or even slight irritation on the rabbit skin (Monsanto 1973, 1982). In early patch-tests with human volunteers no irritating effects were noted (Monsanto Co 1950, 1955). CBS caused slight irritation on the conjunctivae of the rabbit eye (Monsanto 1973).


The test substance was classified as not skin and eye irritating according to the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964) (F.H.S.A.).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to guideline study with acceptable restrictions (e.g. no 48 h observation time point)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 48 h observation time point, 24 h exposure time, intact and abraded skin tested
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h
Number of animals:
6 (3 males and 3 females)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not determined
Remarks on result:
other: score not determined at 48 h
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Remarks on result:
other: score not determined at 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Other effects:
No other effects.

Slight erythema (4 x erythema grade 1.0 in 3 amimals on intact skin; 9 x erythema grad 1 in 4 animals on abraded skin) and edema (6 x edema grad 1 in 3 animals on abraded skin) were observed at 24 h after treatment. No signs of erythema or edema were visible at 72 h and the study was terminated.

Interpretation of results:
GHS criteria not met
Executive summary:

In a skin irritation study with 6 New Zealand White rabbits 0.5 g of CBS moistened with saline was applied under semi-occlusive dressings to clipped intact and abraded skin of each of the rabbits (three males and three females) for 24 hours. There were four application sites in each rabbit (two sites for intact, two sites for abraded skin). 24 hours post application, a Draize score of 0.33 in 6 animals was seen at the intact application sites which were reversible within 72 hours (Monsanto Co. 1982).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable documented study report, with limitiations (e.g. type of application and type coverage not documented)
Principles of method if other than guideline:
Skin irritation study.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
Up to 168 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Test conditions:
Mode of administration: not reported
Exposure time: 24 hours
Number of animals: 6
Test result:
Mean erythema score: 0.00
Mean edema score: 0.00
Other effects: none
Healing time: not applicable

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study with 6 rabbits, neither erythema nor edema were detected at any time points evaluated (4 h, 24 h, 48, 72, and 168 h post-application) in any of the treated animals (Monsanto 1973).
Executive summary:

In a skin irritation study with 6 rabbits, neither erythema nor edema were detected at any time points evaluated (4 h, 24 h, 48, 72, and 168 h post-application) in any of the treated animals (Monsanto 1973).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
100 mg of finely ground test substance was placed into the conjunctival sac of 6 New Zealand albino male and female rabbits. A 7-d observation period followed application. Eye responses were scored in accordance with the Federal Hazardous Substance Act, 21 CFR, § 191.12 (1964).
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48, 72, 168 h
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: at 24 h: slight erythema and moderate discharge
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
5.66
Max. score:
20
Reversibility:
fully reversible within: 40 hours
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
5.66
Max. score:
20
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
20
Reversibility:
fully reversible

Number of animals: 6
Test results:
Draize score: 1.8/110
1 hr: slight erythema, copious discharge

24 h: slight erythema in five instances, moderate discharge

The test substance was slightly irritating to the rabbit eye, 1.8/110.0

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation test with six New Zealand albino rabbits the test substance caused slightly and transient erythema of the conjunctivae. No effects were noted after 48 hours. An irritation score of 1.8 (Draize score: 1.8/110) was indicated (Monsanto 1973).
Executive summary:

In an eye irritation test with six New Zealand albino rabbits the test substance caused slightly and transient erythema of the conjunctivae. No effects were noted after 48 hours. An irritation score of 1.8 (Draize score: 1.8/110) was indicated (Monsanto 1973).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

Non-human information

In a skin irritation study with 6 New Zealand White rabbits 0.5 g of CBS moistened with saline was applied under semi-occlusive dressings to clipped intact and abraded skin of each of the rabbits (three males and three females) for 24 hours. There were four application sites in each rabbit (two sites for intact, two sites for abraded skin). 24 hours post application, 4 erythema grad 1.0 were observed in 3 animals at the intact application sites which were reversible within 72 hours (Monsanto Co. 1982). In another skin irritation study with 6 rabbits, neither erythema nor edema were detected at any time points evaluated (4 h, 24 h, 48, 72, and 168 h post-application) in any of the treated animals (Monsanto 1973).

Human information

The test substance CBS have been tested in early patch tests with human volunteers. No skin irritation was observed after dermal application for 24 hours (0/204) or 48 hours (0/196) (Monsanto Co 1950, 1955).

Eye

Non-human information

In an eye irritation test with six New Zealand albino rabbits the test substance caused slightly and transient erythema of the conjunctivae. No effects were noted after 48 hours. An irritation score of 1.8 (Draize score: 1.8/110) was indicated (Monsanto 1973).

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.