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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

SDCC is of very low  toxicity by the oral and percutaneous route. 
LD50 oral (OECD 423) ≥ 2500 mg/kg bw
LD50 dermal (OECD 402) ≥ 5000 mg/kg bw

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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Both sexes were tested (females are preferred)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River Ltd, Margate, Kent, UK
Age/weight at study initiation : ♂: 8 weeks, 232-238 g, ♀: 8 weeks, 226-242 g
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a group of three fasted animals of the other sex at the same dose level.
Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Statistics:
Method of determination of LD50: ATC method flow chart
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
No death occurred during the study.
Clinical signs:
other: Hunched posture and lethargy were noted in all animals four hours after dosing. Pilo-erection was noted in females only four hours after dosing with hunched posture noted on females only one day after dosing.
Gross pathology:
No abnormalities were noted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River Ltd, Margate, Kent, UK
Age/weight at study initiation ♂: 8 weeks/216-238 g, ♀: 8 weeks/204-238 g
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.27 mL/kg bw

Duration of exposure:
24 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occurred during the study.
Clinical signs:
other: Signs of systemic toxicity noted were lethargy, decreased respiratory rate, laboured respiration, ptosis, pilo-erection, ataxia, hunched posture and increased lachrymation. All animals recovered one day after dosing. There were no signs of dermal irritati
Gross pathology:
No abnormalities were noted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

SDCC is of very low toxicity by the oral and percutaneous route. The low vapour pressure (SDDC: 2 × 10–4 Pa at 25°C) and the envisaged use pattern do not necessitate investigation of acute inhalation toxicity.


Justification for selection of acute toxicity – oral endpoint
The reliable GLP compliant OECD Guideline study was chosen.

Justification for selection of acute toxicity – inhalation endpoint
No study required since exposure of humans via inhalation is unlikely taking into account the physico-chemical properties of the substances and the lack of exposure to aerosols, particles or droplets of inhalable size under normal conditions of use.

Justification for selection of acute toxicity – dermal endpoint
The reliable GLP compliant OECD Guideline study was chosen.

Justification for classification or non-classification

The criteria for classification for acute lethal effects are not reached (LD50 oral and dermal: >2000 mg/kg).