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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity of this substance is very low because LD50 values by oral exposure route are high, greater than 5000 mg/kg bw (de Groot 1975, Monsanto 1985). An even low acute oral toxicity of DCBS was also indicated in another rat study (JETOC 1998).
Dermal toxicity in the rabbit is low concern based on 0% mortality (0/10) when dosed once at 5000 mg/kg bw. No significant systemic signs of toxicity and no treatment-related gross pathology findings were noted (Monsanto 1985).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
other: CDr (Sprague-Dawley derivated)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 1 % methocel A15C (Dow)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: at 24 hours after application some animals exhibited decrease food consumption, several were hypoactive and a few exhibited other abnormalities
Clinical signs:
other:

Mortality: all animals survived throughout the study (0/10)

Body weight: 3%5 females exhibited slight weight loss at day 7, but all animals gained weight between days 7 and 14.

Pharmacologic and toxicologic signs: most animals were free of abnormalites on day of dosing. However, at 24 hours animals exhibited decrease food consumption, several were hypoactive and a few exhibited other abnormalities

Abnormalities: nasal discharge (1/10 day 6); red nasal discharge (1/10 day 1); oral discharge (1/10 day 1, 1/10 day 7); wet rales (1/10 2 h); ocular discharge (2/10 at day 1); red ocular discharge (1/10 at day 1, 2 and 3); urinary straining (2/10 day 1); unthrifty coat (1/10 at day 1, 2,4, 5, 6 and 7 and 2/10 at day 3; soft stool (1/10 4 h; hypoactivity: 7/10 day 1, 4/10 day 2, 1/19 day 3;food consumption decreased (10/10 day 1, 6/10 day 2, 3/10 day 3, 1/10 day 4; eyes closed 2/10 day 1 and 2). Abnormalities continued in a few animals through day 7 but all animals were free of abnormalities from day 8 through termination of the study (day 14).

Gross postmortem observation: gross postmortem observations were similar to those seen in control animals in this laboratory.

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP and guideline study with male and female CDR rats no mortality was observed after treatment with 5000 mg/kg bw. Three of the five treated females exhibited slight weight loss at day 7 but all treated animals gained weight between day 7 and termination of the study (day 14). Most animals were free of abnormalities on the day of dosing. However, after 24 hours all animals exhibited decreased food consumption, several were hypoactive and a few exhibited other abnormalities (nasal discharge, oral discharge, wet rales, ocular discharge, urinary straining, unthrifty coat, soft stool, and eyes closed). In addition, no treatment-related gross pathology findings were noted. Based on these findings, the authors concluded that the LD50 of DCBS in rats is greater than 5000 mg/kg bw (Monsanto 1985).

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: most animals were free of signs of systemic toxicity, although several occurences of nasal discharge were seen
Clinical signs:
other:

Mortality: all animals survived throughout the study, therefore the dermal LD50 of DCBS is greater than 5000 mg/kg bw

Body weight: most animals exhibited little or no weight change at day 7, but all gained weight between days 7 and 24.

Pharmacologic and toxicologic signs: most animals were free of signs of systemic toxicity, although several occurences of nasal discharge were seen, primarily in a single animal, and a few occurences of ocular irritation were noted in another animal.

Gross postmortem observations: Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.

Interpretation of results:
GHS criteria not met
Executive summary:

The acute dermal toxicity of the test substance DCBS was evaluated with New Zealand White rabbits in a GLP and guideline study. Moistened test substance was applied for 24 h directly to the clipped intact skin of New Zealand White rabbits at a dose of 5000 mg/ kg bw (5 males and 5 females.). A 14-day observation period followed application. No mortality was observed. Most animals were free of signs of systemic toxicity, although several occurrences of nasal discharge were seen, primarily in a single animal, and a few occurrences of ocular irritation were noted in another animal. Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation. Based on these findings the authors concluded that the LD50 is greater than 5000 mg/kg bw (Monsanto 1985).

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Acute toxicity: oral

In a GLP and EPA guideline study with male and female CD rats no mortality was observed after treatment with 5000 mg/kg bw. Three of the five treated females exhibited slight weight loss at day 7 but all treated animals gained weight between day 7 and termination of the study (day 14). Most animals were free of abnormalities on the day of dosing. However, after 24 hours all animals exhibited decreased food consumption, several were hypoactive and a few exhibited other abnormalities (nasal discharge, oral discharge, wet rales, ocular discharge, urinary straining, unthrifty coat, soft stool, and eyes closed). In addition, no treatment-related gross pathology findings were noted. Based on these findings, the authors concluded that the LD50 of DCBS in rats is greater than 5000 mg/kg bw (Monsanto 1985).

This finding confirmed an earlier acute oral toxicity study with rats, which identified an oral LD50 of 10000 mg/kg bw(de Groot 1975).

In another acute oral toxicity study no dose-related increases in mortality were observed. Male and female Crj: CD (SD) rats received 1077, 1401, 1821, 2367, 3077 and 4000 mg DCBS /kg by gavage. Mortality occurred in males at doses of 2367 (2/5) mg/kg bw and higher (2367 mg/kg bw (2/5), 3077 mg/kg bw (2/5), 4000 mg/kg bw (1/5) and in females at doses of 1401 mg/kg bw (1/5) and higher (2367 mg/kg bw (4/5), 3077 mg/kg bw (1/4), 4000 mg/kg bw(4/5). Clinical signs such as tremor, convulsion, decreased locomotor activity, deep respiration, piloerection, chromodacryorrhea and perigenital region solid with urine, as well as low body weight in comparison to control were observed in both sexes. Based on the absence of a dose-response relationship of mortality the author assessed that the LD50 value for male rats is higher than 1821 mg/kg bw and for female rats higher than 1077 mg/kg bw (JETOC 1998).

Moreover, in a very limited documented publication, the LD50 for mice is assessed to be 8500 mg/kg bw (Vorobeva 1968).

Acute toxicity: dermal

The acute dermal toxicity of the test substance DCBS was evaluated with New Zealand White rabbits in a GLP and EPA guideline study. Moistened test substance was applied for 24 h directly to the clipped intact skin of New Zealand White rabbits at a dose of 5000 mg/ kg bw (5 males and 5 females.). A 14-day observation period followed application. No mortality was observed. Most animals were free of signs of systemic toxicity, although several occurrences of nasal discharge were seen, primarily in a single animal, and a few occurrences of ocular irritation were noted in another animal. Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation. Based on these findings the authors concluded that the LD50 is greater than 5000 mg/kg bw (Monsanto 1985).

Justification for classification or non-classification

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