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Diss Factsheets

Administrative data

Description of key information

Reliable acute toxicity studies are available via the oral and dermal route. The results show that SDBR is not toxic after single exposure.

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
Study period:
Feb- April 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Version / remarks:
1991
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Stability: stable
Solubility: in toluene, methylene chloride
Insoluble: in water
Storage conditions: room temperature
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA, USA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 49 to 74 days old
- Weight at study initiation: 221.9-249.4g (males), 201.3-216.9g (females)
- Fasting period before study: yes, o/n prior to dosing
- Housing: group housed in polycarbonate cages with hardwood chips as contact bedding
- Diet: commercial rodent feed (AgWay Prolab, Waverly, NY), ad libitum
- Water: municipal tap water, ad libitum
There were no known contaminants present in the feed, bedding, or water expected to interfere with the test data.
- Acclimatization period: 6 days

ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum 10-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 March 1994 To: 13 April 1994
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: <10 mL/ kg bw

DOSAGE PREPARATION:
The test substance was suspended in corn oil and placed at 70ºC for 60 minutes to allow the test substance to melt. The suspension was cooled at room temperature and the suspension was continuously stirred during the dosing period.
Doses:
Total dose: 5000 mg/kg bw (animals were dosed twice within a period of 4 hours)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were weighed on Day 7 and on Day 14 prior to sacrifice. At the end of the study, the animals were sacrificed by CO2 inhalation.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died at this dose level during the observation period.
Clinical signs:
other: No signs of toxicity were noted throughout the study.
Gross pathology:
No unusual lesions were noted in any of the animals at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an acute oral toxicity study in male and female rats, the LD50 was found to exceed 5000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD0
Value:
5 000 mg/kg bw
Quality of whole database:
One study is available (Klimisch 1 study).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Density: 1.08 kg/L
Storage conditions: at ambient room temperature
Species:
rat
Strain:
Wistar
Remarks:
Crl:(WI) WU BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 194-206g (males), 143-175g (females)
- Fasting period before study: No
- Housing: During exposure period animals were housed individually.
Type of coverage:
occlusive
Vehicle:
maize oil
Details on dermal exposure:
After the exposure period materials and residues were removed as much as possible. The animals were observed for mortality for 14 days.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were dosed at 5 mL/kg bw of a 400 mg/mL suspension of the test item.
Body weights were recorded at the start of the study, and on days 3, 7 and 14.
Clinical signs were observed at least once daily (including 1 hour and within 4 hours after dosing), skin effects were evaluated using the Draize system on day 1 after test item removal and on days 3, 7 and 14 of the study.
Gross necropsy was done at sacrifice (carbon dioxide).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs were observed after treatment of 5 males and 5 females with the 2000 mg/kg bw dose level.
Gross pathology:
Macroscopic examination of the animals at the end of the observation period did not reveal treatment-related gross changes.
Other findings:
Skin effects observed consisted of very slight erythema and very slight oedema in all treated rats on day 1 of the study. In addition, the 5 females showed very slight scaliness on day 3 of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an acute dermal toxicity study in male and female rats, the LD50 was found to exceed 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD0
Value:
2 000 mg/kg bw
Quality of whole database:
One study is available (Klimisch 1 study).

Additional information

Based on the results of an acute oral toxicity study in male and female rats, the LD50 was found to exceed 5000 mg/kg bw. Based on the results of an acute dermal toxicity study in male and female rats, the LD50 was found to exceed 2000 mg/kg bw. 

Justification for classification or non-classification

Based on the available results, the test substance is not classified for acute toxicity according to Regulation (EC) No 1272/2008.