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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key information is based on a classic in-vivo oral single dose study in rats with multiple doses of CERAPHYL® 60 (6% solids) ranging from 2 to 64 ml per kg.

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:
July 5 - July 2 6, 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act
Version / remarks:
Not specified
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
CERAPHYL® 60: 1-Propanaminium, 3-(D-gluconoylamino)-N-(2-hydroxyethyl)-N,N-dimethyl-, chloride: 60% (58 - 62%)
CERAPHYL® 60 (6% solids): 1-Propanaminium, 3-(D-gluconoylamino)-N-(2-hydroxyethyl)-N,N-dimethyl-, chloride: 6% (10x dilution of CERAPHYL® 60)
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No further details
Route of administration:
other: The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.
Vehicle:
unchanged (no vehicle)
Doses:
2, 4, 8, 16, 32, 64 ml CERAPHYL® 60 (6% solids)/kg corrseponding with 120, 240, 480, 960, 1920 and 3840 mg test material per kg bw.
No. of animals per sex per dose:
30 albino male and female rats equally distributed at a total of five ats per group.
Control animals:
no
Details on study design:
Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No postmortem, or histopathology examinations were performed in this particular study.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 840 mg/kg bw
Based on:
test mat.
Mortality:
No mortality at any of the doses.
Clinical signs:
Not examined
Body weight:
Not examined
Gross pathology:
Not examined
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 in rats was > 2000 mg/kg, the upper limit for CLP classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 840 mg/kg bw
Quality of whole database:
Performed according to the Federal Hazardous Substances Act.

Additional information

Justification for classification or non-classification

The oral LD50 in rats was > 2000 mg/kg, the upper limit for CLP classification.