Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
dermal absorption
Type of information:
other: Expert statement based on available experimental work , QSAR and physical/chemical properties.
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluation based on reliable experiments and internationally accepted QSAR tools.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other: Expert statement
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Constituent 1

Test animals

Species:
rabbit

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
no effects
Absorption in different matrices:
A low potential for dermal absorption or metabolism of Ceraphyl 55 is suggested by the results of an acute dermal test on five male and five New Zealand White rabbits (MB Research Laboratories, 2004). No mortality occurred after exposing the rabbits to a semi-occlusive dorsal application corresponding with a dose of 2000 mg/kg. The body weight values were in the normal range and the necropsy did not reveal any abnormalities. The result of the study showed that the acute dermal toxicity LD50 of Ceraphyl 55 was >2000 mg/kg.
Examination of local skin effects showed no evidence of potential for irritation, but skin sensitization was observed in three of the four studies reported in this dossier. Positive sensitization was observed in local lymph node assays (LLNAs) after applications of ≥ 25% Ceraphyl 55 in an acetone/olive oil mixture. Although only limited absorption is required for inducing sensitization, the chemical must gain access to the viable epidermis in order to elicit a cutaneous immune response.

Applicant's summary and conclusion

Conclusions:
The evaluation of the toxicokinetics of Ceraphyl 55 shows that based on its physicochemical properties absorption via the dermal route is rather limited.