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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The key value is based on an in-vivo study from pre-GLP period.

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:
November 7, 1978 to November 21, 1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
According to Hagan, E.C. (1959) Acute Toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17 - 25.
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Diet: ad libitum (Wayne animal feeds):
- Water: ad libitum):
- Housing: maintained under standard laboratory conditions for a minimum of seven days, and fasted overnight prior to adminstration of the test material.
- Weight at study initiation: 214-240 g
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
The rats were dosed individually by gavage, according to bodyweight
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage.
Observations were made daily thereafter to a total of fourteen days.
Animals sacrificed at the end of the 14-day observation period were subjected to complete gross necropsy.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat. (total fraction)
Mortality:
1 male died on day 9 following exposure.
Clinical signs:
other: Slight Depression in two male rats after 24 h following dosing.
Gross pathology:
No gross changes observed in the surviving rats, fibrous tissue encasing heart and lungs in the rat that died.
Interpretation of results:
GHS criteria not met
Conclusions:
CERAPHYL® 70 is not a toxic material orally to rats under conditions of this test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Acceptable.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Rat received an oral dose of 5000 mg/kg bw. Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage. Further observations were made daily thereafter to a total of fourteen days. One male died on day 9 and slight depression observed in two male rats. The LD50 was > 5000 mg/kg bw.

Justification for classification or non-classification

CERAPHYL® 70 is not toxic when orally administered to rats and classification according to CLP or GHS criteria were not met.