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Diss Factsheets

Administrative data

Description of key information

DCBS showed only very slight and transient skin and eye irritation in guideline studies performed according to GLP with rabbits (Monsanto Co. 1985).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Principles of method if other than guideline:
Method: other: exposure time: 24 h (no further data)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 and 24 h
Observation period:
up to 72 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 4 h treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 4 h treatment
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 24 h treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 24 h treatment
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
8
Reversibility:
other: 4 h treatment no effects
Remarks on result:
other: 4 h treatment
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 24 h treatment

The test substance DCBS was essentially non-irritating to the skin. The only irritation seen was transient very slight (barely perceptible) erythema in one animal at the sites exposed for 24 hours under occlusive covering. This animal was free of irritation at both sites by day 7. The primary irritation index for the 24 -hour exposures was 0.1.

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP and EPA Guideline study with New Zealand White rabbits, the dermal application of 0.5 g of the solid test substance DCBS to 6 animals for 4 and 24 hours was essentially non-irritating to the skin. The only irritation seen was transient very slight (barely perceptible) erythema in one animal at the sites exposed for 24 hours under occlusive covering. This animal was free of irritation at both sites by day 7. The primary irritation index for the 24 -hour exposures was 0.1 (Monsanto Co. 1985).

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes
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 h and 7 d after treatment
Number of animals or in vitro replicates:
6
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: slight effects 1 h after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: slight effects 1h after treatment
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: *1/6 animal with (+) grade at 24 and 48 h, reversible within 72 h

DCBS produced only mild, transient ocular irritation, consisting primarily of mild conjunctivial irritation (redness, chemosis and/or discharge) and iridial changes, with most severe effects occurring at one hour. No responses considered to be positive under the reference regulations were seen. All animals were free of ocular irritation within 24 hours to 7 days after instillation of the test material.

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP and EPA guideline study with six New Zealand White rabbits, a single application of 0.1cc DCBS in the lower conjunctivial sac of the right eye produced only mild and transient ocular irritation, consisting primarily of mild conjunctivial irritation (redness, chemosis and/or discharge) and iridial changes, with most severe effects occurring at one hour. All animals were free of ocular irritation within 24 hours to 7 days after instillation of the test material (Monsanto Co. 1985).

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

Additional information

Skin

Non-human information

In a GLP and EPA Guideline study with New Zealand White rabbits, the dermal application of 0.5 g of the solid test substance DCBS to 6 animals for 4 and 24 hours was essentially non-irritating to the skin. The only irritation seen was transient very slight (barely perceptible) erythema in one animal at the sites exposed for 24 hours under occlusive covering. This animal was free of irritation at both sites by day 7. The primary irritation index for the 4 h-hour exposure was 0 and for the 24 -hour exposures 0.1 (Monsanto Co. 1985).

Eye

Non-human information

In a GLP and EPA guideline study with six New Zealand White rabbits, a single application of 100 mg DCBS in the lower conjunctivial sac of the right eye produced only mild and transient ocular irritation, consisting primarily of mild conjunctivial irritation (redness, chemosis and/or discharge) and iridial changes, with most severe effects occurring at one hour. All animals were free of ocular irritation within 24 hours to 7 days after instillation of the test material (Monsanto Co. 1985).

Justification for classification or non-classification

No classification is required according to the classification of regulation no. 1272/2008 (GHS).